The Use of Lignocaine and Bupivacaine Mix in Adult Safe Male Circumcision
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

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)
    

Intervention name(s): 3-3-4 mix; 4-4-2
Intervention type(s): Drug; Drug
Intervention description(s): the drug mix included lidocaine, bupivacaine and water for injection; 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.
Other intervention name(s): Lidocaine; Bupivaciane; Lidocaine; Bupivacaine
Intervention MeSH terms: Lidocaine; Bupivacaine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain, Visual analogue scale