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

NCT ID: NCT02245126

Last Updated: 2014-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-01-31

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.

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)

Conditions

Post Operative Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

3-3-4 mix

Intervention Type: DRUG

the drug mix included lidocaine, bupivacaine and water for injection

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.

Group Type: ACTIVE_COMPARATOR

4-4-2

Intervention Type: DRUG

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.

Interventions

3-3-4 mix

the drug mix included lidocaine, bupivacaine and water for injection

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Lidocaine; Bupivaciane; Lidocaine; Bupivacaine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Makerere University

OTHER

Sponsor Role: collaborator

International Hospital Kampala

OTHER

Sponsor Role: lead

Responsible Party

Moses Galukande

director of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moses Galukande, MD

Role: PRINCIPAL_INVESTIGATOR

International Hospital

Locations

International Hospital Kampala

Kampala, Kampala, Uganda

Countries

Uganda

References

Galukande M, Nakaggwa F, Busisa E, Sekavuga Bbaale D, Nagaddya T, Coutinho A. Long term post PrePex male circumcision outcomes in an urban population in Uganda: a cohort study. BMC Res Notes. 2017 Oct 30;10(1):522. doi: 10.1186/s13104-017-2845-9.

Reference Type: DERIVED

PMID: 29084559 (View on PubMed)

Other Identifiers

REC REF 2014-050

Identifier Type: -

Identifier Source: org_study_id