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Intrathecal Morphine for Postoperative Pain in Bariatric Surgery
NCT02731430Phase 3
Key facts
- Status
- Unknown
- Start
- Dec 2015
- Primary completion
- Mar 2016
- Sponsor
- Assiut University
- Modality
- Small Molecules
- Drugs
- morphine
- Conditions
- postoperative pain
01
Overview
Phase 3, randomised trial of morphine in postoperative pain (2 arms), sponsored by Assiut University. Primary endpoint: Total postoperative analgesic consumption. Status: unknown.
02
Design
2 arms- Study design
- Randomized
Morphine Group
0.3mg morphine + 1.2ml bupivacaine 0.5% intrathecally
Control Group
0.3ml saline + 1.2ml bupivacaine 0.5% intrathecally
03
Who it enrols
Adult patients (30-50 years) with ASA II-III and BMI >40 or >35 with comorbidity undergoing laparoscopic bariatric surgery. Excludes patients with advanced cardiac, respiratory, renal, or hepatic disease, coagulation disorders, infection at injection site, drug/alcohol abuse, or psychiatric illnesses.
04
Endpoints
Primary
Total postoperative analgesic consumption
Secondary
Visual Analogue Scale scores
Time to first request of rescue analgesia
Incidence of side effects
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