Overview

This trial is active, not recruiting.

Condition postoperative pain
Treatments intrathecal morphine, intrathecal saline
Phase phase 2/phase 3
Sponsor Assiut University
Start date December 2015
End date March 2016
Trial size 100 participants
Trial identifier NCT02731430, 274

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
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.
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.
(Placebo Comparator)
received 0.3ml saline added to 1.2mlof bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia.
intrathecal saline
received 0.3ml saline added to 1.2mlof bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia.

Primary Outcomes

Measure
Total postoperative analgesic consumption.
time frame: 24 hours postoperative

Secondary Outcomes

Measure
Visual analogue scale (VAS) scores
time frame: 24 hours postoperative
Time to first request of rescue analgesia.
time frame: 24 hours postoperative
Tolerability as assessed by the incidence of side effects
time frame: 24 hours postoperative

Eligibility Criteria

Male or female participants from 20 years up to 50 years old.

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.

Additional Information

Official title Intrathecal Morphine for Postoperative Pain Management in Patients Undergoing Laparoscopic Bariatric Surgery
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Assiut University.