The Use of Lignocaine and Bupivacaine Mix in Adult Safe Male Circumcision
Primary Purpose
Post Operative Pain
Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
3-3-4 mix
4-4-2
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain focused on measuring Pain, Visual analogue scale
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
Sites / Locations
- International Hospital Kampala
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lignocaine-bupivacaine lower dosage mix
Lignocaine-bupivacaine higher dosage mix
Arm Description
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
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.
Outcomes
Primary Outcome Measures
pain score
measure at intervals after the procedure is completed
Secondary Outcome Measures
Full Information
NCT ID
NCT02245126
First Posted
August 2, 2014
Last Updated
September 17, 2014
Sponsor
International Hospital Kampala
Collaborators
Makerere University
1. Study Identification
Unique Protocol Identification Number
NCT02245126
Brief Title
The Use of Lignocaine and Bupivacaine Mix in Adult Safe Male Circumcision
Official Title
The Use of Lignocaine and Bupivacaine Mix in Adult Safe Male Circumcision; Less is More
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Hospital Kampala
Collaborators
Makerere University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Pain, Visual analogue scale
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
217 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lignocaine-bupivacaine lower dosage mix
Arm Type
Experimental
Arm Description
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
Arm Title
Lignocaine-bupivacaine higher dosage mix
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
3-3-4 mix
Other Intervention Name(s)
Lidocaine, Bupivaciane
Intervention Description
the drug mix included lidocaine, bupivacaine and water for injection
Intervention Type
Drug
Intervention Name(s)
4-4-2
Other Intervention Name(s)
Lidocaine, Bupivacaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain score
Description
measure at intervals after the procedure is completed
Time Frame
immediate post operative period
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moses Galukande, MD
Organizational Affiliation
International Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Hospital Kampala
City
Kampala
ZIP/Postal Code
414
Country
Uganda
12. IPD Sharing Statement
Citations:
PubMed Identifier
29084559
Citation
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.
Results Reference
derived
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The Use of Lignocaine and Bupivacaine Mix in Adult Safe Male Circumcision
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