Vocal local versus pharmacological treatments for pain management in tubal ligation procedures in rural Kenya: a non-inferiority trial

Abstract

BackgroundVocal local (VL) is a non-pharmacological pain management technique for gynecological procedures. In Africa, it is usually used in combination with pharmacological analgesics. However, analgesics are associated with side-effects, and can be costly and subject to frequent stock-outs, particularly in remote rural settings. We compared the effectiveness of VL + local anesthesia + analgesics (the standard approach), versus VL + local anesthesia without analgesics, on pain and satisfaction levels for women undergoing tubal ligations in rural Kenya.MethodsWe conducted a site-randomised non-inferiority trial of 884 women receiving TLs from 40 Marie Stopes mobile outreach sites in Kisii and Machakos Districts. Twenty sites provided VL + local anesthesia + analgesics (control), while 20 offered VL + local anesthesia without additional analgesics (intervention). Pain was measured using a validated 11-point Numeric Rating Scale; satisfaction was measured using 11-point scales.ResultsA total of 461 women underwent tubal ligations with VL + local anesthesia, while 423 received tubal ligations with VL + local anesthesia + analgesics. The majority were aged ≥30 years (78%), and had >3 children (99%). In a multivariate analysis, pain during the procedure was not significantly different between the two groups. The pain score after the procedure was significantly lower in the intervention group versus the control group (by 0.40 points; p = 0.041). Satisfaction scores were equally high in both groups; 96% would recommend the procedure to a friend.ConclusionVL + local anesthesia is as effective as VL + local anesthesia + analgesics for pain management during tubal ligation in rural Kenya. Avoiding analgesics is associated with numerous benefits including cost savings and fewer issues related to the maintenance, procurement and monitoring of restricted opioid drugs, particularly in remote low-resource settings where these systems are weak.Trial registrationPan-African Clinical Trials Registry PACTR201304000495942.

Role of vocal distraction analgesia on pain management in the office hysteroscopy procedure: a randomized controlled studya

“…The multivariable analysis confirmed that the vocal distraction analgesia was a protective factor for pain (VAS > 4) (OR adj = 0.30; 95%CI: 0.11-0.78) and the other investigated factors resulted not significantly related to pain. This result agrees with the study carried out in Kenya [29], in which the majority of respondents were over 30 (78%), married (96%) with 3 or more children (99%).…”

“…A study in Kenya of 1000 women has demonstrated the effectiveness of vocal distraction as a method for reducing the perception of pain in the inability to use anaesthetic drugs [29]. In this study, women were divided into two groups: in one they were subjected to local anaesthesia and vocal distraction during the tying of the salpinges with a mini-laparotomy technique without the use of opioid analgesics, while in the control group the latter was administered.…”

A Standardized Protocol for Post-Partum Salpingectomy with Suture Ligation: A Prospective Feasibility Study

“…Danis et al [22] compared postpartum salpingectomy to post-partum bilateral tubal ligation in a retrospective consecutive cohort, and found significantly longer operative times for those undergoing post-partum salpingectomy (71.44 min ± 5.81 vs. 59.13 min ± 16 min p = 0.003) similar to our own findings. Wagar et al [21] reported a shorter median operative time for post-partum salpingectomy compared to bilateral tubal ligation immediately following vaginal delivery (30)(31)(32)(33)(34)(35)(36)(37)(38) vs. 34 min [IQR 26-42], p = 032). However, 97% of post-partum salpingectomy cases utilized a bipolar electrocautery device [21].…”

“…The use of post-partum-female permanent contraception varies widely by country [27]. Descriptions on the use of post-partum tubal ligations for permanent contraception and complication rates are available for at least two low and middle-income countries [28,29], and descriptions on how to increase accessibility by alternative approaches to analgesia are also available [30]. Our procedure described here would allow access not only to contraception, but also potential ovarian cancer risk reduction.…”

An Overview of Outpatient Hysteroscopy

“…Nonpharmacological management, e.g., music, conversation, and support by the medical personnel during the procedure, can also significantly reduce anxiety and pain during hysteroscopy, which has also been demonstrated in other surgical procedures with the patient awake [43]. This reduces the need for pharmacological pain relief and increases patient satisfaction with the care received [44].…”