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


METHODS
We 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.


RESULTS
A 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.


CONCLUSIONS
VL + 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.


BACKGROUND
Pan-African Clinical Trials Registry PACTR201304000495942.
Sarah C
SC
Keogh
Kenzo
K
Fry
Edwin
E
Mbugua
Mark
M
Ayallo
Heidi
H
Quinn
George
G
Otieno
Research, Monitoring, and Evaluation Team, Health System Department, Marie Stopes International, 1 Conway Street, London W1T 6LP, UK. thoai.ngo@mariestopes.org.
Thoai D
TD
Ngo
D000328:Adult; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D000779:Anesthetics, Local / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D007630:Kenya; D008012:Lidocaine / Q000627:therapeutic use*; D016014:Linear Models; D015999:Multivariate Analysis; D059408:Pain Management / Q000379:methods*; D017060:Patient Satisfaction; D012424:Rural Population; D013246:Sterilization, Tubal / Q000379:methods*; D014147:Tramadol / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
D000701:Analgesics, Opioid; D000779:Anesthetics, Local; D014147:Tramadol; D008012:Lidocaine