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

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dc.contributor.authorOchieng, G.O.
dc.contributor.authorKeogh, Sarah C.
dc.contributor.authorFry, Kenzo
dc.contributor.authorMbugua, Edwin
dc.contributor.authorAyallo, Mark
dc.contributor.authorQuinn, Heidi
dc.contributor.authorNgo, Thoai D.
dc.date.accessioned2015-04-07T08:12:13Z
dc.date.available2015-04-07T08:12:13Z
dc.date.issued2014
dc.descriptiondoi:10.1186/1472-6874-14-21en_US
dc.description.abstractBackground: 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. Conclusion: 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. Trial registration: Pan-African Clinical Trials Registry PACTR201304000495942en_US
dc.description.sponsorshipThis paper is made possible by the support from the American People through the United States Agency for International Development (USAID) through the project Support for International Family Planning Organizations (SIFPO), a five-year program funded by the USAID under Cooperative Agreement No. AID-OAA-A-10-00059. The contents are the responsibility of MSI and do not necessary reflect the views of USAID or the United States Government. The sponsor of the study had no role in study design, data collection, data analysis, data interpretation, or writing of this paper. All authors had full access to all the data in the studyen_US
dc.identifier.citationBMC Women's Health (Impact Factor: 1.66). 02/2014; 14(1):21en_US
dc.identifier.issn1472-6874
dc.identifier.other1472-6874
dc.identifier.urihttp://www.biomedcentral.com/1472-6874/14/21
dc.identifier.urihttp://ir-library.ku.ac.ke/handle/123456789/12450
dc.language.isoenen_US
dc.publisherBioMed Centralen_US
dc.subjectVocal localen_US
dc.subjectKenyaen_US
dc.subjectFamily planningen_US
dc.subjectPain managementen_US
dc.subjectTubal ligationen_US
dc.titleVocal local versus pharmacological treatments for pain management in tubal ligation procedures in rural Kenya: a non-inferiority trialen_US
dc.typeArticleen_US
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