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.
Highlights
Vocal local (VL) is a non-pharmacological pain management technique for gynecological procedures
While one study found that relaxation reduced pain following gynecological surgery [8], a review [9] showed that rhythmic breathing was not effective
The objective was to test whether VL + local anesthesia (LA) provide at least equivalent pain relief as the standard approach of using VL + LA with pharmacological analgesics
Summary
Vocal local (VL) is a non-pharmacological pain management technique for gynecological procedures. In rural sub-Saharan Africa, the provision of analgesics during gynecological procedures can be expensive, subjected to frequent stock-outs, and associated with potential side effects. Vocal local (VL) was developed as an alternative to pharmacological approaches to pain management In these settings, Marie Stopes International (MSI) uses VL and local anesthesia (LA) in place of opioid. Some studies suggest that distraction techniques reduce pain when used in adjunct to analgesics during acute pain and surgical procedures [3,4,5]; but their effectiveness as a substitute for analgesics has not been assessed. Some evidence suggests that empathetic attention reduces pain, anxiety, need for drugs and procedure time [6], yet other studies showed it hinders patients’ ability to cope with the pain [7]. Another review evaluating relaxation as the sole analgesic found limited evidence that relaxation was an effective form of pain relief [10]
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