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

NCT02245126 | Completed

• 1 other identifier: REC REF 2014-050
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Keywords

Pain, Visual analogue scale

Outcome Measures

Primary Outcomes (1)

• pain score

  measure at intervals after the procedure is completed

  immediate post operative period

Study Arms (2)

Lignocaine-bupivacaine lower dosage mix

EXPERIMENTAL

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

Drug: 3-3-4 mix

Lignocaine-bupivacaine higher dosage mix

ACTIVE COMPARATOR

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.

Drug: 4-4-2

Interventions

3-3-4 mix DRUG

the drug mix included lidocaine, bupivacaine and water for injection

Also known as: Lidocaine, Bupivaciane

Lignocaine-bupivacaine lower dosage mix

4-4-2 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.

Also known as: Lidocaine, Bupivacaine

Lignocaine-bupivacaine higher dosage mix

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• all adult male aged18 and 49 years

You may not qualify if:

• 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

Sponsors & Collaborators

• International Hospital Kampala: lead
• Makerere University: collaborator

Study Sites (1)

International Hospital Kampala

Kampala, Kampala, 414, Uganda

Location

Related Publications (1)

• 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.

  PMID: 29084559 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Lidocaine; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Moses Galukande, MD

  International Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of Surgery

Study Record Dates

• First Submitted: August 2, 2014
• First Posted: September 19, 2014
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: September 19, 2014

Record last verified: 2014-09

Locations

UG (1)