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Hum. Reprod. Advance Access originally published online on February 14, 2006
Human Reproduction 2006 21(6):1461-1466; doi:10.1093/humrep/del023
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© The Author 2006. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Effect of local lignocaine gel application for pain relief during suction termination of first-trimester pregnancy: a randomized controlled trial

H.W.R. Li1, C.Y.G. Wong, S.S.T. Lo and S.Y.S. Fan

The Family Planning Association of Hong Kong, Wanchai, Hong Kong SAR, China

1 To whom correspondence should be addressed at: The Family Planning Association of Hong Kong, 9th Floor, Southorn Centre, 130 Hennessy Road, Wanchai, Hong Kong, China. E-mail: hwli{at}famplan.org.hk and raymondli{at}hkam.org.hk


   Abstract
Top
 Abstract
Introduction
 Materials and methods
 Results
 Discussion
 Acknowledgements
 References
 
BACKGROUND: This study evaluated the effectiveness of local lignocaine gel application in pain control during first-trimester suction termination of pregnancy (STOP). METHODS: In this prospective randomized placebo-controlled double-blind trial, 131 women undergoing STOP between 7 and 10 weeks of gestation were studied. They were computer-randomized to receive 2% lignocaine gel or placebo (KY Jelly) locally applied to the cervix 1 min before cervical manipulation/dilatation. They all had cervical priming with misoprostol and premedication with diazepam and pethidine. Pain scores on a verbal analogue scale preoperative, at cervical manipulation/dilatation, intraoperative and 1 h post-operative, as well as the patients’ satisfaction level towards pain control, were compared. RESULTS: The lignocaine gel group had significantly reduced overall intraoperative pain score compared with placebo group (P = 0.021). No significant difference in pain score between the two groups was demonstrated at other time points. Subgroup analysis revealed that the difference in overall intraoperative pain scores between the two groups was evident in the multiparous (P = 0.015) but not the nulliparous subjects. CONCLUSION: The use of local lignocaine gel application reduces overall intraoperative pain in multiparous women undergoing first-trimester STOP preceded by misoprostol cervical priming and premedication for conscious sedation.

Key words: lignocaine gel/pain relief/randomized controlled trial/suction evacuation/termination of pregnancy


   Introduction
Top
 Abstract
 Introduction
Materials and methods
 Results
 Discussion
 Acknowledgements
 References
 
Surgical abortion is the most commonly practised gynaecological operation (Hong Kong College of Obstetricians and Gynaecologists, 2003). In Hong Kong, legal abortions are performed in gazetted institutions, i.e. private and public hospitals and the Family Planning Association of Hong Kong (FPAHK). Suction evacuation is the standard surgical technique employed for first-trimester pregnancy terminations. In the year of 2004, there were 12 551 first-trimester legal abortions performed in Hong Kong’s hospitals, 7825 of which were by suction evacuation. In FPAHK, 3329 were performed in 2004, all of which were by suction evacuation (Department of Health, personal communications). About 85% of our hospital cases (Hong Kong College of Obstetricians and Gynaecologists, 2003) and all cases in FPAHK are carried out as day procedures.

Although suction evacuation is a quick procedure requiring 5–10 min, it has been reported that up to 97% of women experienced pain during the procedure (Belanger et al., 1989Go). Suction evacuation can be performed under either general or local anaesthesia, but the latter is associated with less cost and anaesthesia-related complications and is recommended by Royal College of Obstetricians and Gynaecologists (2004). Nonetheless, patient suffers from pain without general anaesthesia. For pain relief, paracervical block with a local anaesthetic agent is commonly used, but its efficacy in pain reduction is controversial. Some randomized studies reported a significantly reduced pain when paracervical block is administered compared with placebo (Glantz and Shomento, 2001Go; Egziabher et al., 2002Go). However, some others reported that paracervical block offered no significant effect in terms of pain control (Kan et al., 2004Go). The use of paracervical block for pain control has also been reported in some other minor gynaecological procedures like hysteroscopy and colposcopy, and conflicting results have been reported. A local study has reported that paracervical anaesthesia not only failed to reduce pain during outpatient hysteroscopy but also carried a risk of introducing bradycardia and hypotension because of inadvertent intravenous administration (Lau et al., 1999Go).

Lignocaine gel is a local anaesthetic agent which is widely used in various clinical procedures. Its use is associated with less risk, but its effect in pain control for suction evacuation has not been studied. Hence, we conducted this prospective randomized placebo-controlled double-blind study to investigate the effectiveness of local application of lignocaine gel in pain control during suction termination of first-trimester pregnancy.


   Materials and methods
Top
 Abstract
 Introduction
 Materials and methods
Results
 Discussion
 Acknowledgements
 References
 
Subject recruitment
Patients attending our Family Planning Association for first trimester induced abortions were recruited if the following criteria were met: (i) age over 16 years, (ii) normal general and gynaecological examinations, (iii) between 7 and 10 weeks of gestation on the day of operation, (iv) uterine size corresponding to gestational age or ultrasound dating, (v) being ethnic Chinese and Cantonese speaking and (vi) no history of complicated medical or surgical problems for which operation in community-based day-care setting was contraindicated. Those with known allergy to lignocaine or prostaglandin or medical contraindications to the use of prostaglandins were also excluded. The study was approved by the Ethics Panel of the FPAHK.

The patients were counselled by the operating surgeon regarding the purpose and nature of the study. Written informed consent was sought before recruitment.

Assuming a reduction of pain level by 0.5 standard deviations was to be acceptable, the minimum sample size required would be 64 in each treatment arm to give a test significance of 0.05 and a power of 80%. An additional 12 subjects (making up to 70 per arm) were recruited to compensate for drop-outs.

Intervention and randomization
A sealed envelope containing the allocated intervention for each recruited patient, either 2% lignocaine jelly (Xylocaine Jelly®, AstraZeneca, Sodertalje, Sweden) or KY jelly® (Johnson & Johnson, Sezanne, France), was issued, according to a computer-generated randomization list. The randomization was only read by an operating theatre nurse who was not involved in pain assessment. The patient and the surgeon were blinded to the randomization. KY jelly, a non-medicated lubricant, was used as placebo as it resembled Xylocaine Jelly in appearance.

Suction evacuation
The operation was performed by two gynaecologists (HWRL and CYGW), according to the following standard protocol. Misoprostol 400 µg was given vaginally at 1–2 h (for multiparous women) or 3–5 h (for nulliparous women) before the operation for cervical priming. All patients received oral diazepam 5 mg and i.m. injection of pethidine 1 mg/kg body weight at 30 and 15 min, respectively, before the operation. After cleansing and draping, 3 ml of the lubricant agent (lignocaine gel or KY jelly) was applied digitally to the surface of the uterine cervix during bimanual examination and another 7 ml to the set of Hegar dilators and vaginal speculum for lubrication. The lubricant agent was presyringed by a theatre nurse, according to the randomization envelope. The patient and the surgeon were blinded to it. Although some of the agent would stay on the vaginal mucosa as well during digital application, the total amount given to each subject was identical. After 1 min, the cervix was dilated with Hegar dilators if necessary, and suction evacuation was performed using a number 7 or 8 Karman catheter with an electrical vacuum machine. A repeat dose of i.m. injection of pethidine was available should the patient complained of intolerable pain.

Assessment of pain and other outcome parameters
The surgeon graded the level of sedation of the patient preoperatively and intraoperatively, according to a standard scale (level 1, patient anxious and agitated or restless or both; level 2, patient co-operative, oriented and tranquil; level 3, patient responds to commands only; level 4, asleep and a brisk response to loud auditory stimulus; level 5, asleep and a sluggish response to loud auditory stimulus and; level 6, asleep and no response to loud auditory response) (Ramsay et al., 1974Go). The patient was asked by the surgeon or a nurse, blinded to the randomization, to grade the level of pain that she perceived on a verbal analogue scale from 0 to 10 (0, ‘no pain at all’ and 10, ‘intolerable pain’) at the following time points: (i) at injection of pethidine; (ii) on arrival to the operating theatre for any preoperative pain (e.g. pain because of side effects of misoprostol); (iii) during cervical manipulation and/or dilatation; (iv) immediately after operation for overall intraoperative pain and (v) 1 h after operation. Before discharge, the patient was also asked to grade her level of satisfaction towards pain control (5, ‘excellent’; 4, ‘satisfactory’; 3, ‘fair’; 2, ‘not very satisfactory’ and 1, ‘totally unsatisfactory’).

Statistical analysis
Comparison of categorical variables between groups was performed using the {chi}2-test. For continuous variables, the Student’s t-test and Mann–Whitney U-test were used for parametric and non-parametric data, respectively. All statistical analyses were performed using the Statistical Program for Social Sciences (SPSS Inc., Version 11.5, Chicago, IL, USA). A P value of <0.05 was considered as statistically significant.


   Results
Top
 Abstract
 Introduction
 Materials and methods
 Results
Discussion
 Acknowledgements
 References
 
A total of 140 women consented to participate in the study during the period from April to June 2005. Among them, 70 each were randomized to receive placebo (KY jelly) and lignocaine gel. However, nine were later excluded from the study because of incomplete data collection. This left 67 women in the placebo group and 64 in the lignocaine gel group available for analysis (Figure 1). None of the subjects required additional dose of pethidine intraoperatively.


Figure 1
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  		Figure 1. Flow-chart showing the progress of participants through the trial.

 

There were no significant difference in the socio-demographic background of the two groups with respect to age, marital status, education level, body weight, gestational age, parity and number of previous surgical and medical abortions (Table I).


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  		Table I. Demographic and clinical characteristics of the valid subjects

 

Table II summarizes the ease of cervical dilatation, sedation scale, pain scores and patient satisfaction levels. There were no significant differences in ease of cervical dilatation as well as in preoperative and intraoperative sedation levels among the two groups. Concerning the preoperative and intraoperative sedation levels, all subjects were classified at level 1, 2 or 3. With regard to the pain scores, a significantly lower score for overall intraoperative pain was revealed in the lignocaine gel group (mean ± SD = 6.50 ± 2.26) compared with the placebo group (mean ± SD = 7.37 ± 1.98; P = 0.021). However, there was no significant difference in pain scores between the two groups at pethidine injection, on arrival to the operating theatre, during cervical manipulation and/or dilatation and 1 h after operation (P > 0.05). The patient satisfaction level towards pain control was also not significantly different among the two groups (P > 0.05).


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  		Table II. Comparison of the ease of cervical dilatation, sedation scale, pain scores and patient satisfaction levels between the lignocaine gel treatment group and the placebo (KY jelly) group

 

Further subgroup analysis of the pain scores and patient satisfaction level in nulliparous and multiparous subjects is summarized in Table III. A significantly lower score for overall intraoperative pain in the lignocaine gel group compared with the placebo group can be shown only in the multiparous subgroup (P = 0.015) but not in the nulliparous subgroup of subjects (P = 0.383). Lignocaine gel treatment also significantly lowered the pain score at 1 h post-operative compared with placebo for the multiparous (P = 0.042) but not the nulliparous (P = 0.686) subgroup. No statistically significant difference was found in the pain scores at all other time points between the lignocaine gel group and the placebo group for both nulliparous and multiparous subjects.


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  		Table III. Subgroup analysis of the nulliparous and multiparous subjects comparing the sedation scale, pain scores and patient satisfaction levels between the lignocaine gel treatment group and the placebo (KY jelly) group

 

A comparison between the nulliparous and multiparous subgroups revealed that the latter had significantly higher intraoperative sedation level, lower pain scores preoperatively, during cervical manipulation/dilatation and intraoperatively, as well as higher satisfaction level towards pain control (Table IV).


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  		Table IV. Comparison of the sedation level, pain scores and patient satisfaction levels between the nulliparous and multiparous subgroups

 


   Discussion
Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
Acknowledgements
 References
 
Lignocaine gel is a simple and convenient local anaesthetic agent with minimal adverse effect. However, there is limited evidence regarding the effectiveness of its use in pain control during suction termination of pregnancy (STOP). There is only one report on the use of a dicaine-containing lubricant jelly for suction termination of first-trimester pregnancy, which suggested no significant difference in the ease of cervical dilatation between use and non-use of the medication. However, the same study reported significantly more satisfactory cervical dilatation in the group using dicaine-containing lubricant jelly compared with the group using lignocaine injection (Xu et al., 1990Go). Yet, the efficacy in pain relief was not reported in this study. For insertion of intrauterine device, there was a report on significant reduction in pain score by pretreatment with 2% lignocaine gel intracervically (Oloto et al., 1996Go). There were also some studies reporting on the use of local lignocaine application in hysteroscopy. A randomized controlled study reported that lignocaine spray significantly reduced pain during outpatient hysteroscopy (Soriano et al., 2000Go), whereas another randomized controlled trial conducted locally found that local application of lignocaine gel was not effective in reducing hysteroscopy-associated pain (Wong et al., 2000Go).

Our study is the first reported randomized double-blind placebo-controlled trial on the efficacy of local lignocaine gel for pain control in first-trimester STOP. KY jelly was used as placebo, because it resembled Xylocaine Jelly in appearance. Although there is a slight difference in consistency between the two which the surgeons with experience might differentiate, it would unlikely affect the validity of our results as the pain scores were given by the patients who did not know the exact agent applied. Only the sedation levels were scored by the surgeon, but this would not be influenced by Xylocaine Jelly. Although pain perception is subjective, bias owing to differences in individuals’ pain threshold was overcome by randomization and was further reassured by the lack of significant difference in the baseline pain scores at pethidine injection and on arrival to the operating theatre between the lignocaine gel and placebo groups.

We demonstrated a significant reduction in overall intraoperative pain level in the lignocaine gel group compared with the placebo group. However, there was no significant difference in pain scores between the two groups during presuction cervical manipulation, the step where we believed that topical anaesthetic agent would exert effect, if any. Theoretically, topical anaesthetic application could only reduce the pain component because of cervical manipulation/dilatation but not the pain component because of uterine instrumentation and contraction, because the upper part of the uterus derives its sensory innervation different from the cervix (the upper part of the uterus is innervated by the ovarian nerve plexus, whereas the lower part and the cervix is innervated by the parasympathetic plexus S2–S4). We postulate that our findings might be because of the short interval between lignocaine gel application and cervical manipulation/dilatation; the arbitrarily assigned 1-min interval might be inadequate for absorption of the agent and onset of action through the cervix. With passage of time during the operation, the local anaesthetic effect might peak subsequently, thus contributing to reduced pain during the suction procedure when the suction catheter passed to and fro repeatedly through the cervix. This might have resulted in the reduced overall pain level intraoperatively. Specific information about the pharmacokinetics of lignocaine gel applied locally to the vagina/cervix is limited. However, some studies on local anaesthesia of genital mucosa with a lidocaine/prilocaine combination cream in laser treatment of human papillomavirus lesions suggested that an application time of 4–20 min would be optimal (Monsonego and Semaille, 2000Go). Further studies on the effect of different application time intervals on pain level would help to determine the optimal protocol. Also, with routine use of misoprostol for cervical priming before suction evacuation, the pain component because of cervical dilatation would have been minimized in the first place. Hence, the lignocaine gel would help in reducing pain because of passage of the suction catheter back and forth during the whole procedure rather than that arising from cervical dilatation specifically.

Further subgroup analysis revealed that lignocaine gel reduced overall intraoperative pain only in the multiparous but not the nulliparous subjects. The reason for the differential effect of parity was uncertain. A similar phenomenon was shown in another local study on co-treatment of diclofenac with misoprostol for cervical priming before suction termination of first-trimester pregnancy, where a marginal benefit in pain relief was shown in the treatment group only in the multiparous but not the nulliparous subgroup (Li et al., 2003Go). We demonstrated that nulliparous subjects in general were more agitated and had higher pain scores both preoperatively and intraoperatively than multiparous subjects (Table IV). As pain is a subjective perception and the pain response can be modified by past experience of delivery and history of previous surgical abortion, it is understandable that the nulliparous might have higher anxiety and pain levels. With a lower background pain perception, the multiparous women might thus have more noticeable additional effect of pain relief from lignocaine.

Despite the reduced overall intraoperative pain score in the lignocaine gel group compared with the placebo group, there was no significant difference in the patients’ satisfaction level to pain control upon discharge. Actually about 60% of subjects in both treatment and placebo groups found the pain control ‘satisfactory’ or ‘excellent’, and less than 10% in both groups found that pain control was ‘not very satisfactory’ or ‘totally unsatisfactory’. This might be because of the amnesiac effect of diazepam which helped patients in both groups to forget the painful feelings during the operation.

To our knowledge, this was the first randomized controlled study in the peer-reviewed literature to evaluate the usefulness of local application of lignocaine gel for pain control in suction termination of first-trimester pregnancy. As most of these operations are performed as day procedures and local anaesthesia is the preferred mode of pain control, a simple convenient form of local anaesthetic, like lignocaine gel, that involve minimal cost and side effect, would be beneficial.

In conclusion, the use of local lignocaine gel application reduces overall intraoperative pain in multiparous women undergoing first-trimester STOP preceded by misoprostol cervical priming and premedication for conscious sedation.


   Acknowledgements
Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 Acknowledgements
References
 
The authors thank Ms Yau-Yin Shum, nursing sister in-charge, and all other nursing staff of the Operating Theatre, FPAHK, for their assistance in patient recruitment and data collection. We also thank the Health Statistics Section of the Department of Health, The Government of the Hong Kong Special Administrative Region of the People’s Republic of China, for provision of STOP statistics as background information.


   References
Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 Acknowledgements
 References
 
Belanger E, Melzack R and Lauzon P (1989) Pain of first-trimester abortion: a study of psychosocial and medical predictors. Pain 36,339–350.[CrossRef][ISI][Medline]

Egziabher TG, Ruminjo JK and Sekadde-Kigondu C (2002) Pain relief using paracervical block in patients undergoing manual vacuum aspiration of uterus. East Afr Med J 79,530–534.[Medline]

Glantz JC and Shomento S (2001) Comparison of paracervical block techniques during first trimester pregnancy termination. Int J Gynaecol Obstet 72,171–178.[CrossRef][Medline]

Hong Kong College of Obstetricians and Gynaecologists (2003) Territory-Wide Audit in Obstetrics and Gynaecology. HKCOG, Hong Kong SAR, China.

Kan ASY, Ng EHY and Ho PC (2004) The role and comparison of two techniques of paracervical block for pain relief during suction evacuation for first-trimester pregnancy termination. Contraception 70,159–163.[CrossRef][ISI][Medline]

Lau WC, Lo WK, Tam WH and Yuen PM (2003) Paracervical anaesthesia in outpatient hysteroscopy: a randomized double-blind placebo-controlled trial. Br J Obstet Gynaecol 106,356–359.

Li CFI, Wong CYG, Chan CPB and Ho PC (2003) A study of co-treatment of nonsteroidal anti-inflammatory drugs (NSAIDs) with misoprostol for cervical priming before suction termination of first trimester pregnancy. Contraception 67,101–105.[CrossRef][ISI][Medline]

Monsonego J and Semaille C (2000) Local anaesthesia of genital mucosa with a lidocaine/prilocaine combination cream before laser therapy of human papillomavirus lesions. Eur J Dermatol 10,607–610.[ISI][Medline]

Oloto EJ, Bromham DR and Murty JA (1996) Pain and discomfort perception at IUD insertion—effect of short-duration, low-volume, intracervical application of two percent lignocaine gel (InstillagelTM)—a preliminary study. Br J Fam Plann 22,177–180.

Ramsay MA, Savege TM, Simpson BR and Goodwin R (1974) Controlled sedation with alphaxalone-alphadolone. Br Med J 920,656–659.

Royal College of Obstetricians and Gynaecologists (2004) The Care of Women Requesting Induced Abortion: Evidence-Based Clinical Guideline Number 7. RCOG Press, London, UK.

Soriano D, Ajaj S, Chuong T, Deval B, Fauconnier A and Darai E (2000) Lidocaine spray and outpatient hysteroscopy: randomized placebo-controlled trial. Obstet Gynecol 96,661–664.[Abstract/Free Full Text]

Wong AYK, Wong KS and Tang LCH (2000) Stepwise pain score analysis of the effect of local lignocaine on outpatient hysteroscopy: a randomized, double-blind, placebo-controlled trial. Fertil Steril 73,1234–1237.[CrossRef][ISI][Medline]

Xu DZ, Li MF, Wu XM, Li LS, Ma QL, Fang QL, Zhang HY and Li GY (1990) Randomized trial of the effect of drugs on cervical dilatation for termination of first trimester pregnancy. Contraception 41,663–670.[ISI][Medline]

Submitted on October 10, 2005; resubmitted on December 3, 2005; accepted on January 13, 2006.


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This Article
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