The Use of Lignocaine and Bupivacaine Mix in Adult Safe Male Circumcision; Less is More
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 217
- Locations
- 1
- Primary Endpoint
- pain score
Study Overview
Brief Summary
Using routinely collected data to compare different concentrations of locally applied anaesthetic drugs and determine which concentrations give better pain control during voluntary medical Male circumcision.
Detailed Description
The objective of this study therefore was to assess self-reported pain and adverse events when using two different concentrations of lignocaine and bupivacaine mixture while performing routine safe medical circumcision (SMC).
Methods Design This was an observational analytical study.
Setting At an urban high volume SMC site in a resource limited setting, over a 6 weeks period.
Participants Adult males aged18 - 49 years presenting for routine voluntary SMC were recruited for enrollment. All men were offered voluntary HIV counseling and testing before the surgery, received group counseling /health education on HIV prevention, were offered HIV testing, individual counseling where necessary to address questions and to clarify any queries, and free condoms were available. All participants were screened for contraindications to SMC such as active sexual transmitted infections (STI), commonly manifesting as urethral discharge or penile ulcers.
Ethical consideration All participants after they were counselled and provided written informed consent. Ethical approval was obtained from the Makerere College of Health Sciences Ethics and Research Committee.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •all adult male aged18 and 49 years
Exclusion Criteria
- •severe comorbid states such as sickle cell disease
- •uncontrolled diabetes
- •hypertension
- •active sexually transmitted infections and genital ulcers
- •in addition known allergy to lidocaine or bupivacaine
Arms & Interventions
Lignocaine-bupivacaine lower dosage mix
Men who received the 3-3-4 local anaesthetic mix( 3 cc of lignocaine 2% , 3cc of bupivacaine 0.5% and 4cc of water for injection)
3-3-4 mix was administered
Intervention: 3-3-4 mix (Drug)
Lignocaine-bupivacaine higher dosage mix
In this group (4-4-2 group) eligible men were receiving an injection of the 4-4-2 local anesthetic mix ( composed of 4cc of parental lignocaine 2%, 4cc of parental bupivacaine 0.5% and 2cc of water for injection). This mix is given once before commencement of the surgical procedure safe male circumcision.
Intervention: 4-4-2 (Drug)
Outcomes
Primary Outcomes
pain score
Time Frame: immediate post operative period
measure at intervals after the procedure is completed
Secondary Outcomes
No secondary outcomes reported
Investigators
Moses Galukande
director of Surgery
International Hospital Kampala