The Use of Lignocaine and Bupivacaine Mix in Adult Safe Male Circumcision

Post Operative Pain Clinical Trial

Official title:

The Use of Lignocaine and Bupivacaine Mix in Adult Safe Male Circumcision; Less is More

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02245126
• Other study ID #: REC REF 2014-050
• Status: Completed
• Phase: N/A
• First received: August 2, 2014
• Last updated: September 17, 2014
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: September 2014
• Source: International Hospital Kampala
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Lignocaine and Bupivacaine (LiB) mixtures and procedure Lignocaine 2% and bupivacaine 0.5% were procured locally, from suppliers licensed and approved by the national drug authority (NDA), and was within the expiry date. The 4-4-2 mix was 4cc of Lignocaine 2%, 4cc of 0.5% bupivacaine and 2cc of water for injection, all drawn into a 10cc syringe. The 3-3-4 mix was 3cc of Lignocaine 2%, 3cc of bupivacaine 0.5% and 4 cc of water for injection.

We assigned participants to the two groups (each group on alternative weeks). We administered additional local analgesia for those who experienced break-through pain during the procedure. We recorded the mix ratio, the time the procedure commenced and ended using a stop clock, presence of break-through pain during SMC, and pain at 30 and 60 minutes after SMC (post-operative). We encouraged clients to report pain and a visual analogue score (VAS) pain chart was used to estimate pain intensity. Post-operative pain was graded as mild if the VAS score were 0-5, moderate if scores were 6-8 and severe if 9-10. We monitored the clients in the recovery room for additional post-operative pain and oral analgesia were given when and if was needed.

Other adverse events: participants were observed for central nervous system (CNS) toxicity, convulsions, coma and respiratory depression and cardiovascular system (CVS) toxicity Bradycardia pulse rate < 60bpm (beats per minute)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• 3-3-4 mix
the drug mix included lidocaine, bupivacaine and water for injection
• 4-4-2
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.

Locations

Country	Name	City	State
Uganda	International Hospital Kampala	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
International Hospital Kampala	Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score	measure at intervals after the procedure is completed	immediate post operative period	No