Treatment of pain following keyhole surgery in West Africa
Phase 2
Completed
- Conditions
- Pain following laparoscopic cholecystectomySurgeryPost-operative pain
- Registration Number
- ISRCTN17667918
- Lead Sponsor
- Obafemi Awolowo University
- Brief Summary
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31388637 (added 04/04/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 69
Inclusion Criteria
1. Aged 18 years or older
2. Undergoing elective laparoscopic cholecystectomy for symptomatic gallstone disease
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Number of patients recruited over a 24 month period<br> 2. Compliance with randomised treatment allocation assessed by the proportion of patients who receive their randomised treatment allocation<br> 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<br>
- Secondary Outcome Measures
Name Time Method Completion of nausea assessment (numerical rating scale) at 2, 6, 12, and 24 hours postoperatively,