Intrathecal Morphine for Postoperative Pain Management in Patients Undergoing Laparoscopic Bariatric Surgery
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Assiut University
- Enrollment
- 100
- Primary Endpoint
- Total postoperative analgesic consumption.
Study Overview
Brief Summary
this study compares the use of intrathecal morphine, to multimodal analgesic techniques for postoperative pain management following laparoscopic bariatric surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •American Society of Anesthesia (ASA) II-III patients.
- •Aged 30-50 years.
- •The body mass index (BMI) of the patients needed to be over 40 kg/m² or over 35 kg/m² with at least one comorbidity.
Exclusion Criteria
- •Patients with a known allergy to the study drugs.
- •Advanced cardiac, respiratory, renal or hepatic disease.
- •Coagulation disorders.
- •Infection at or near the site of intrathecal injection.
- •Drug or alcohol abuse.
- •Psychiatric illnesses that may interfere with perception and assessment of pain.
Arms & Interventions
group I: morphine group
received 0.3mg morphine (0.3ml) added to 1.2ml of bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia.
Intervention: intrathecal morphine (Drug)
group II: control group
received 0.3ml saline added to 1.2mlof bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia.
Intervention: intrathecal saline (Drug)
Outcomes
Primary Outcomes
Total postoperative analgesic consumption.
Time Frame: 24 hours postoperative
the efficacy of the studied dose of intrathecal morphine in reducing postoperative analgesic consumption.
Secondary Outcomes
- Time to first request of rescue analgesia.(24 hours postoperative)
- Visual analogue scale (VAS) scores(24 hours postoperative)
- Tolerability as assessed by the incidence of side effects(24 hours postoperative)
Investigators
Ahmad Mohammad Abd El-Rahman
Lecturer of anesthesia, icu, and pain management
Assiut University