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Clinical Trials/NCT02731430
NCT02731430
Unknown
Phase 2

Intrathecal Morphine for Postoperative Pain Management in Patients Undergoing Laparoscopic Bariatric Surgery

Assiut University0 sites100 target enrollmentDecember 2015

Overview

Phase
Phase 2
Intervention
intrathecal morphine
Conditions
Postoperative Pain
Sponsor
Assiut University
Enrollment
100
Primary Endpoint
Total postoperative analgesic consumption.
Last Updated
10 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
April 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmad Mohammad Abd El-Rahman

Lecturer of anesthesia, icu, and pain management

Assiut University

Eligibility Criteria

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

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

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)

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