Intrathecal Morphine for Postoperative Analgesia Following Laparoscopic Bariatric Surgery

April 6, 2016 updated by: Ahmad Mohammad Abd El-Rahman, Assiut University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: 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: 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.
Drug: intrathecal saline
received 0.3ml saline added to 1.2mlof bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total postoperative analgesic consumption.
Time Frame: 24 hours postoperative
the efficacy of the studied dose of intrathecal morphine in reducing postoperative analgesic consumption.
24 hours postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

April 3, 2016

First Submitted That Met QC Criteria

April 6, 2016

First Posted (Estimate)

April 7, 2016

Study Record Updates

Last Update Posted (Estimate)

April 7, 2016

Last Update Submitted That Met QC Criteria

April 6, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 274

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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