Intrathecal Morphine for Postoperative Analgesia Following Laparoscopic Bariatric Surgery

Phase 2

• Conditions: Postoperative Pain
• Interventions: Drug: intrathecal saline; Drug: intrathecal morphine

• Registration Number: NCT02731430
• Lead Sponsor: Assiut University

Brief Summary

this study compares the use of intrathecal morphine, to multimodal analgesic techniques for postoperative pain management following laparoscopic bariatric surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Primary Completion: 2016-03
• Status Verified: 2016-04
• Study Completion: 2016-04
• Study First Submitted: 2016-04-03
• Study First Submitted QC: 2016-04-06
• Last Update Submitted: 2016-04-06
• Study First Posted: 2016-04-07
• Last Update Posted: 2016-04-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
group II: control group	intrathecal saline	received 0.3ml saline added to 1.2mlof bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia.
group I: morphine group	intrathecal morphine	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.

Primary Outcome Measures

Name	Time	Method
Total postoperative analgesic consumption.	24 hours postoperative	the efficacy of the studied dose of intrathecal morphine in reducing postoperative analgesic consumption.

Secondary Outcome Measures

Name	Time	Method
Time to first request of rescue analgesia.	24 hours postoperative
Visual analogue scale (VAS) scores	24 hours postoperative	postoperative pain scores
Tolerability as assessed by the incidence of side effects	24 hours postoperative	the incidence of side effects