Post Operative PainNCT02245126
The Use of Lignocaine and Bupivacaine Mix in Adult Safe Male Circumcision
A study testing 3-3-4 mix and 4-4-2 in people with Post Operative Pain, run by International Hospital Kampala at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- 3-3-4 mix and 4-4-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteUganda
- Study dates
- Jan 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- all adult male aged18 and 49 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Lignocaine and Bupivacaine Mix in Adult Safe Male Circumcision; Less is More
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.
Read the 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
- Being tested
- 3-3-4 mix, 4-4-2
- Keywords
- Pain, Visual analogue scale
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-3-4 mixDrug
Also called Lidocaine, Bupivaciane
the drug mix included lidocaine, bupivacaine and water for injection
4-4-2Drug
Also called Lidocaine, Bupivacaine
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: 4-4-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
measure at intervals after the procedure is completed
Measured: immediate post operative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Hospital Kampala
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University
- Responsible party
- Principal investigator, Moses Galukande, International Hospital Kampala
- Investigators
- Moses Galukande, MD, Principal investigator, International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245126
- Sponsor's protocol ID
- REC REF 2014-050
- Status last verified
- Sep 2014
- First submitted
- 2 Aug 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29084559
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Lignocaine and Bupivacaine Mix in Adult Safe Male Circumcision; Less is More
- ClinicalTrials.gov ID
- NCT02245126
- Acronym / sponsor ID
- REC REF 2014-050
- Conditions
- Post Operative Pain
- Keywords
- Pain, Visual analogue scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- International Hospital KampalaUniversity, hospital or other
- Collaborators
- Makerere University
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lignocaine-bupivacaine lower dosage mix | Experimental | Drug: 3-3-4 mixMen 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 |
| Lignocaine-bupivacaine higher dosage mix | Active comparator | Drug: 4-4-2In 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all adult male aged18 and 49 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-3-4 mixAlso: Lidocaine, Bupivacianethe drug mix included lidocaine, bupivacaine and water for injection | Drug | Lignocaine-bupivacaine lower dosage mix |
| 4-4-2Also: Lidocaine, BupivacaineIn 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 | Lignocaine-bupivacaine higher dosage mix |
Primary outcome
pain score
Time frame: immediate post operative period
measure at intervals after the procedure is completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
- Derived from this study: PubMed 29084559Galukande 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moses Galukande, MD principal investigator
International Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-3-4 mix and 4-4-2 in people with Post Operative Pain, run by International Hospital Kampala at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: immediate post operative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02245126, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2014.