<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02245126</url>
  </required_header>
  <id_info>
    <org_study_id>REC REF 2014-050</org_study_id>
    <nct_id>NCT02245126</nct_id>
  </id_info>
  <brief_title>The Use of Lignocaine and Bupivacaine Mix in Adult Safe Male Circumcision</brief_title>
  <official_title>The Use of Lignocaine and Bupivacaine Mix in Adult Safe Male Circumcision; Less is More</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Hospital Kampala</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Makerere University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>International Hospital Kampala</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Using routinely collected data to compare different concentrations of locally applied&#xD;
      anaesthetic drugs and determine which concentrations give better pain control during&#xD;
      voluntary medical Male circumcision.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study therefore was to assess self-reported pain and adverse events&#xD;
      when using two different concentrations of lignocaine and bupivacaine mixture while&#xD;
      performing routine safe medical circumcision (SMC).&#xD;
&#xD;
      Methods Design This was an observational analytical study.&#xD;
&#xD;
      Setting At an urban high volume SMC site in a resource limited setting, over a 6 weeks&#xD;
      period.&#xD;
&#xD;
      Participants Adult males aged18 - 49 years presenting for routine voluntary SMC were&#xD;
      recruited for enrollment. All men were offered voluntary HIV counseling and testing before&#xD;
      the surgery, received group counseling /health education on HIV prevention, were offered HIV&#xD;
      testing, individual counseling where necessary to address questions and to clarify any&#xD;
      queries, and free condoms were available. All participants were screened for&#xD;
      contraindications to SMC such as active sexual transmitted infections (STI), commonly&#xD;
      manifesting as urethral discharge or penile ulcers.&#xD;
&#xD;
      Ethical consideration All participants after they were counselled and provided written&#xD;
      informed consent. Ethical approval was obtained from the Makerere College of Health Sciences&#xD;
      Ethics and Research Committee.&#xD;
&#xD;
      Lignocaine and Bupivacaine (LiB) mixtures and procedure Lignocaine 2% and bupivacaine 0.5%&#xD;
      were procured locally, from suppliers licensed and approved by the national drug authority&#xD;
      (NDA), and was within the expiry date. The 4-4-2 mix was 4cc of Lignocaine 2%, 4cc of 0.5%&#xD;
      bupivacaine and 2cc of water for injection, all drawn into a 10cc syringe. The 3-3-4 mix was&#xD;
      3cc of Lignocaine 2%, 3cc of bupivacaine 0.5% and 4 cc of water for injection.&#xD;
&#xD;
      We assigned participants to the two groups (each group on alternative weeks). We administered&#xD;
      additional local analgesia for those who experienced break-through pain during the procedure.&#xD;
      We recorded the mix ratio, the time the procedure commenced and ended using a stop clock,&#xD;
      presence of break-through pain during SMC, and pain at 30 and 60 minutes after SMC&#xD;
      (post-operative). We encouraged clients to report pain and a visual analogue score (VAS) pain&#xD;
      chart was used to estimate pain intensity. Post-operative pain was graded as mild if the VAS&#xD;
      score were 0-5, moderate if scores were 6-8 and severe if 9-10. We monitored the clients in&#xD;
      the recovery room for additional post-operative pain and oral analgesia were given when and&#xD;
      if was needed.&#xD;
&#xD;
      Other adverse events: participants were observed for central nervous system (CNS) toxicity,&#xD;
      convulsions, coma and respiratory depression and cardiovascular system (CVS) toxicity&#xD;
      Bradycardia pulse rate &lt; 60bpm (beats per minute)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain score</measure>
    <time_frame>immediate post operative period</time_frame>
    <description>measure at intervals after the procedure is completed</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">217</enrollment>
  <condition>Post Operative Pain</condition>
  <arm_group>
    <arm_group_label>Lignocaine-bupivacaine lower dosage mix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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)&#xD;
3-3-4 mix was administered</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lignocaine-bupivacaine higher dosage mix</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>3-3-4 mix</intervention_name>
    <description>the drug mix included lidocaine, bupivacaine and water for injection</description>
    <arm_group_label>Lignocaine-bupivacaine lower dosage mix</arm_group_label>
    <other_name>Lidocaine</other_name>
    <other_name>Bupivaciane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>4-4-2</intervention_name>
    <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.</description>
    <arm_group_label>Lignocaine-bupivacaine higher dosage mix</arm_group_label>
    <other_name>Lidocaine</other_name>
    <other_name>Bupivacaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all adult male aged18 and 49 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe comorbid states such as sickle cell disease&#xD;
&#xD;
          -  uncontrolled diabetes&#xD;
&#xD;
          -  hypertension&#xD;
&#xD;
          -  active sexually transmitted infections and genital ulcers&#xD;
&#xD;
          -  in addition known allergy to lidocaine or bupivacaine&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moses Galukande, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>International Hospital Kampala</name>
      <address>
        <city>Kampala</city>
        <zip>414</zip>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 17, 2014</last_update_submitted>
  <last_update_submitted_qc>September 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>International Hospital Kampala</investigator_affiliation>
    <investigator_full_name>Moses Galukande</investigator_full_name>
    <investigator_title>director of Surgery</investigator_title>
  </responsible_party>
  <keyword>Pain, Visual analogue scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02245126
org study id: REC REF 2014-050
nct id: NCT02245126
lead sponsor: 
collaborator: 
has dmc: No
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.
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)
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: pain score
time frame: immediate post operative period
description: measure at intervals after the procedure is completed
arm group label: Lignocaine-bupivacaine lower dosage mix
arm group type: Experimental
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 group label: Lignocaine-bupivacaine higher dosage mix
arm group type: Active Comparator
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: 3-3-4 mix
description: the drug mix included lidocaine, bupivacaine and water for injection
arm group label: Lignocaine-bupivacaine lower dosage mix
other name: Lidocaine
other name: Bupivaciane
intervention type: Drug
intervention name: 4-4-2
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.
arm group label: Lignocaine-bupivacaine higher dosage mix
other name: Lidocaine
other name: Bupivacaine
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Moses Galukande, MD
role: Principal Investigator
affiliation: International Hospital
facility: 
country: Uganda
responsible party type: Principal Investigator
investigator affiliation: International Hospital Kampala
investigator full name: Moses Galukande
investigator title: director of Surgery
mesh term: Pain, Postoperative
mesh term: Lidocaine
mesh term: Bupivacaine