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Effect of topical lignocaine on postoperative pain after laparoscopic tubal sterilisation in awake patients.

The introduction of laparoscopic sterilisation resulted in a more than twofold increase in the number of tubal sterilisations. (1) Tubal ligation is a widely accepted method of contraception, in India chosen by 37.3% of women. (2) Initially regional anaesthesia was considered to be safer and produced better surgical results than local anaesthesia. In a retrospective descriptive study conducted on 2 827 cases, laparoscopic tubal ligation with Silastic rings was safely carried out under local anaesthesia with a technical failure rate of 0.14% and a mean operating time of 10 minutes. (3)

Tubal ligation is associated with significant pain, both during and after the operation. Tubal rings produce more pain than clips, both during and after occlusion, as ischaemia from occlusion devices releases pain mediators such as prostaglandins. (4,5) In addition to analgesics, local anaesthetics such as lignocaine and bupivacaine have been applied topically as solutions, (6) injected into the mesosalpinx (7) and instilled cervically into the fallopian tubes. (8) However, either these studies were done under general anaesthesia (9) or they were not placebo-controlled and lacked randomisation. (6,10,11)

This randomised study evaluated whether, compared with a placebo, topical application of 1% lignocaine on the fallopian tubes reduces intra- and postoperative pain in tubal ligation under local anaesthesia.

Materials and methods

A randomised prospective clinical study was conducted in the Obstetrics and Gynaecology department of the All India Institute of Medical Sciences. To achieve power of 0.9 and an alpha coefficient of 0.5, it was determined that at least 15 patients in each group would be required to detect a difference of 2 in the verbal rating pain score. Using a computer-generated random number table, the patients were randomised to receive either 1% lignocaine or normal saline solution dripped onto each fallopian tube (5 ml of solution per fallopian tube) before tubal occlusion, which resulted in two groups: the study lignocaine group and the control placebo group.

All the enrolled patients were undergoing interval tubal ligation, had no history of prior surgery, pelvic inflammatory disease or pelvic mass; all were assessed as ASA1 (American Society of Anesthesiologists physical status 1--healthy), and were medically eligible for tubal ligation. All were told that the surgery would be done under local anaesthesia plus topical application of a solution over the tubes. Informed consent for tubal ligation was taken from both the partners, and they consented to be part of the trial. A detailed history was taken and physical examination was done. Height, weight, pulse and blood pressure were recorded in all patients, and baseline haemoglobin levels were measured. Intravenous sedation using pentazocine (0.5 mg/kg) and diazepam (0.1-0.2 mg/kg) was given to all patients 5 minutes before the procedure. Pain was assessed using a 4-point verbal rating score (VRS) (0 = no pain, 1 = minimal, 2 = mild, 3 = moderate and 4 = severe).12 Ten millilitres of 1% lignocaine was infiltrated at the incision site. The VRS score at incision was measured. Carbon dioxide gas was used to create pneumoperitoneum. The procedure was done using a 10 mm single-puncture, zero-degree laprocator (Karl Storz, Germany). In the study group 10 ml of 1% lignocaine (5 ml over each fallopian tube) was dripped under vision at the isthmus and ampullary region; normal saline was used in the control group. After 60 seconds, Falope rings were applied over each tube at the isthmic region. The VRS at application was noted. The patients were then moved to the recovery room, where the postoperative pulse rate and blood pressure were measured. Intramuscular diclofenac was given to patients who required additional analgesia. VRS scores were measured 15 minutes and 1 hour after the procedure. The nature and site of pain were noted, and side-effects were noted and suitably treated. Intra-operative and postoperative complications were recorded. All patients were discharged 4-5 hours after the procedure, and the VRS was measured at the time of discharge. When the patients came to the outpatient department for stitch removal after 7 days, they were questioned about their recovery at the end of 1 week (expressed as a percentage), whether they would have preferred the surgery to have been done under general anaesthesia, and whether the procedure had been as they had expected, worse or better.

Statistical analysis

The data were analysed using SPSS version 16. The continuous independent samples were analysed using Student's t-test, while continuous non-numerical variables were evaluated using the rank sum test. For categorical variables, Fisher's exact test was applied. The VRS scores at the various time points were analysed using generalised estimating equations.

Results

Of 40 eligible women only 36 were included in the study, 17 in the study group and 19 as controls. One patient had tubal transection, 1 had congenital absence of the left tube, and 2 had dense adhesions. The baseline characteristics were comparable in the two groups (Table I). The mean operative time was 8 minutes (standard deviation (SD) 2.5 minutes, range 4.5-11 minutes). There were no unexpected complications in either group, and pulse and blood pressure measurements before and after the procedure did not differ significantly between the groups.

All patients had a pre-operative VRS score of 0. The mean VRS at incision was minimal (0.7 (SD 1.4) v. 0.4 (SD 0.8) in the study and control groups, respectively). The difference in the pain score in the two groups at 15 minutes, at 1 hour and at discharge was statistically significant. There was no difference in the pain score at ring application between the two groups (Table II). Three patients in the control group required additional analgesia in the form of 1 ml intramuscular diclofenac (75 mg). The site of pain was predominantly abdominal (68% in the study group v. 78% in the controls, not statistically significant);, 31% of study and 20% of control patients had pelvic pain. The total incidence of pain was similar in the two groups. There were only a few minor side-effects such as nausea, vomiting and giddiness, which were similar in the two groups; 94% of study and 89% of control patients had no side-effects. All patients were discharged in a stable condition. Recovery at the end of 1 week was 93% in the two groups. Of the patients in the study group, 68.7% considered the procedure better than they expected, as opposed to 16.7% in the control group; this difference was statistically significant. In the study group 6% of patients and in the control group 11% found the procedure worse than expected, and 33% of control but only 11% of study patients stated that they would have preferred surgery under general anaesthesia. This last difference was also statistically significant.

Discussion

Topically applied local anaesthetic significantly reduced postoperative discomfort after laparoscopic sterilisation. Unlike other studies, this study indicates that application of local anaesthetic at the time of occlusion (pre-emptive analgesia) reduces postoperative pain. (13) It emphasises the usefulness of topical application of 1% lignocaine in providing postoperative analgesia and thereby reducing the requirement for other analgesics. It is speculated that this difference may be due to differening methods of occlusion, as clips result in more ischaemia (13) than the Silastic bands used in our study.

Several studies have looked at local anaesthesia in conjunction with general anaesthesia for pain relief after laparoscopic sterilisation. (6,14) Garwood et al. observed that visceral pain, particularly genito-urinary, is frequently associated with nausea and vomiting. (13) They speculated that the reduction in nausea and vomiting in their study group was due to reduced opiate use as well as afferent inputs to the nervous system being blocked by previous application of lidocaine. However, we found a similar incidence of nausea and vomiting in our two groups.

In conclusion, topical application of lignocaine is a safe, easy and effective means of improving pain control. It reduces the requirement for supplemental analgesia and can be used as an effective alternative to general anaesthesia. This technique can be especially useful at primary health centre level, where facilities for general anaesthesia are not available in a developing country like India. Larger, double-blind studies are needed to confirm its efficacy so that it can be incorporated into routine practice. It should reduce morbidity and prove extremely useful in low-resource settings.

(1.) Sterilization. ACOG Technical Bulletin No. 113. Washington, DC: American College of Obstetricians and Gynecologists, February 1988.

(2.) Ramesh BM, Gulati SC, Retherford RD. Contraceptive use in India. National Family Health Survey (NFHS 3), Subiect report No. 2, 1996.

(3.) Poindexter AN, Abdul Malak M, Fast JE. Laparoscopic tubal sterilization under local anesthesia. Obstet Gynecol 1990;75(1):5-8.

(4.) Dobbs FF, Kumar V, Alexander JI, Hull MGR. Pain after laparoscopy related to posture and ring verus clip sterilization. Br J Obstet Gynaecol 1987;94:262-264.

(5.) Rioux JE, Yuzpe AA. Laparoscopic sterilization: Clinial aspects. In: Sciarra JJ, ed. Gynecology and Obstetrics looseleaf CD-ROM, vol 6. Philadelphia: Lippincott Williams & Wilkins, 1999: chapter 43.

(6.) Mc Kenzie R, Phitayakorn P, Uy TL, Tantisira B, Wadhwa K, Vicinie AF. Topical etidocaine during laparoscopic tubal occlusion for post operative pain relief. Obstet Gynecol 1986;67:447-449.

(7.) Moiniche S, Jorgensen H, Wetterslev J, Dahl JB. Local anaesthetic infiltration for post operative pain relief after laparoscopy: a quantitative and qualitative systematic review of intraperitoneal, port site infiltration and mesosalpinx block. Anesth Analg 2000;90:899-912.

(8.) Schytte T, Soerensen JA, Hauge B, Andersen B. Preoperative transcervical analgesia for laparoscopic sterilization with Filshie clips, a double blind randomized trial. Acta Obstet

ynecol Scand 2003;82(1):57-60.

(9.) Wheatley SA, Millar JM, Jadad AR. Reduction of pain after laparoscopic sterilisation with local bupivacaine: a randomised, parallel, double-blind trial. Br J Obstet Gynaecol 1994;101(5):443-446.

(10.) Pelland PC. Patient acceptance of laparoscopic tubal fulguration versus falope ring banding. Obstet Gynecol 1977;50:106-108.

(11.) Spielman FJ, Hulka JF, Ostheimer GW, Muller RA. Pharmacokinetics and pharmacodynamics of local analgesia for laparoscopic tubal ligations. Am J Obstet Gynecol 1983;146:821-824.

(12.) Jensen MP, Chen C, Brugger AM. Postsurgical pain outcome assessment. Pain 2002;99:101-109.

(13.) Garwood S, Reeder M, Mackenzie IZ, Guillebaud J. Tubal surface lidocaine mediates preemptive analgesia in awake laparoscopic sterilization: A prospective, randomized clinical trial. Am J Obstet Gynecol 2002;186:383-388.

(14.) Helvacioglu A, Weis R. Operative laparoscopy and post operative pain relief. Fertil Steril 1992;57:548-552.

Bindiya Gupta, MD

Department of Obstetrics and Gynaecology, University College of Medical Sciences and Guru Teg Bahadur Hospital, New Delhi, India

Sumana Gurunath, MD

Anupama Bahadur, DNB

Ballika Gupta, MD

Jai Bhagwan Sharma MD, MRCOG

Suneeta Mittal, MD, FRCOG

Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
Table I. Baseline characteristics of the study and control groups

                                           Study group (N=17)

Age (yrs) (mean (SD))                      29.3 (4.1)
Parity (%)
  2                                        33.3
  3                                        50
  4                                        11.1
  5                                        5.56
Weight (kg) (mean (SD))                    48.3 (5.2)
Height (cm) (mean (SD))                    151 (5.96)
Cycle length (d) (mean (SD))               28.9 (1.8)
Duration of menses (d) (mean (SD))         3.9 (0.68)
Retroverted uterus                         8
Pre-procedure pulse rate (/min) (median)   82
Pre-procedure blood pressure,              115 (10.9)
systolic (mmHg) (mean (SD))
Pre-procedure blood pressure,              76 (7)
diastolic (mmHg) (mean (SD))
Haemoglobin (g/dl) (mean (SD))             9.1 (1.2)
VRS at incision (mean (SD))                0.7 (0.6)
SD = standard deviation.

                                           Control group
                                           (N=19)           p-value

Age (yrs) (mean (SD))                      28.6 (3.2)       0.55
Parity (%)
  2                                        18.7
  3                                        62.5             0.66
  4                                        18.7
  5                                        0
Weight (kg) (mean (SD))                    45.5 (6.9)       0.19
Height (cm) (mean (SD))                    149.8 (5.5)      0.53
Cycle length (d) (mean (SD))               28.5 (1.9)       0.55
Duration of menses (d) (mean (SD))         4.2 (0.8)        0.4
Retroverted uterus                         9                0.65
Pre-procedure pulse rate (/min) (median)   84               0.91
Pre-procedure blood pressure,              110 (12.2)       0.9
systolic (mmHg) (mean (SD))
Pre-procedure blood pressure,              70.7 (18.4)      0.9
diastolic (mmHg) (mean (SD))
Haemoglobin (g/dl) (mean (SD))             8.9 (0.8)        0.32
VRS at incision (mean (SD))                0.6 (0.8)        0.73
SD = standard deviation.

Table II. Pain scores in the control and study groups

                            0            15 minutes    60 minutes

Control group (mean (SE))    3.6 (1.8)    2.9 (0.2)     2.3 (0.1)
Study group (mean (SE))      3.3 (0.2)    2 (0.2)       1.2 (0.2)
Difference in pain scores    0.42        -0.88         -1.15
95% CI                      -0.9 - 0.2   -1.4 - -0.3   -1.6 - -0.7
p-value                      0.13         0.002         0.000

                            At discharge

Control group (mean (SE))    1.1 (0.1)
Study group (mean (SE))      0.2 (1)
Difference in pain scores   -0.9
95% CI                      -1.2 - -0.6
p-value                      0.00

SE = standard error; CI = confidence interval.
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Title Annotation:ORIGINAL ARTICLE
Author:Gupta, Bindiya; Gurunath, Sumana; Bahadur, Anupama; Gupta, Ballika; Sharma, Jai Bhagwan; Mittal, Sun
Publication:South African Journal of Obstetrics and Gynaecology
Article Type:Report
Date:Sep 1, 2011
Words:2146
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