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Treatment of pain following keyhole surgery in West Africa

Feasibility study for a randomised controlled trial of bupivacaine, lignocaine with adrenaline, or placebo wound infiltration to reduce postoperative pain after laparoscopic cholecystectomy in West Africa

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17667918
Enrollment
69
Registered
2018-07-03
Start date
2015-07-01
Completion date
Unknown
Last updated
2019-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain following laparoscopic cholecystectomy Surgery Post-operative pain

Interventions

At the end of the procedure, skin, subcutaneous tissue, fascia, and parietal peritoneum will be infiltrated with one of the following solutions: 1. 3 ml of 2% lignocaine with adrenalin

Sponsors

Obafemi Awolowo University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older 2. Undergoing elective laparoscopic cholecystectomy for symptomatic gallstone disease

Exclusion criteria

Exclusion criteria: 1. American Society of Anesthesiology (ASA) physical status class 3+ 2. Pregnant women 3. Acute cholecystitis 4. History of allergy to bupivacaine, lignocaine or related local anaesthetic drugs 4. Known peptic ulcer disease 5. Known opiate addiction 6. Known contraindications to use of NSAIDs such as bronchial asthma 7. If an abdominal drain is inserted or the operation was converted to an open procedure, the patient will not receive the allocated intervention and pain scores will not be collected

Design outcomes

Primary

MeasureTime frame
1. Number of patients recruited over a 24 month period 2. Compliance with randomised treatment allocation assessed by the proportion of patients who receive their randomised treatment allocation 3. Outcome assessment completion assessed by the proportion of pain assessments (measured using both the numerical rating scale and verbal rating scale at 2, 6, 12, and 24 hours postoperatively) and nausea assessments (measured using the numerical rating scale measured at 2, 6, 12, and 24 hours postoperatively) that are completed

Secondary

MeasureTime frame
Completion of nausea assessment (numerical rating scale) at 2, 6, 12, and 24 hours postoperatively,

Countries

Nigeria

Contacts

Public ContactAdewale Adisa

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026