Combined Intrathecal Morphine and Dexmedetomidine Analgesia (ITMandDEX)

May 5, 2015 updated by: Khaled Mohamed Fares, Assiut University

Safety and Efficacy of Dexmedetomidine Addition to Intrathecal Morphine for Postoperative Analgesia in Cancer Patients Undergoing Major Abdominal Surgery

The current study investigated the effect of adding dexmedetomidine to intrathecal morphine for postoperative analgesia in cancer patients undergoing major abdominal surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Opioids, administered intrathecal or epidural, are widely used for postoperative, and chronic nociceptive pain secondary to cancers. Intrathecal injection of morphine to provide postoperative analgesia during the initial 24 h after operation is a widely used technique.The Human studies on the antinociceptive effects of co-administrated intrathecal morphine and dexmedetomidine in postoperative pain are still lacking. In this study, the investigators aimed to compare the synergistic interaction and side-effects of combined intrathecal morphine and dexmedetomidine with either drug alone for postoperative analgesia in cancer patients undergoing major abdominal surgery. Patients were randomly allocated into three groups of 30 patients each to receive either; hyperbaric bupivacaine 0.5% (Group I/Bupivacaine Group), bupivacaine and 0.5 mg morphine (Group II/Morphine Group), bupivacaine and 0.5 mg morphine plus 5 µg of dexmedetomidine (Group III/Morphine-DEX Group). The assigned drugs were dissolved in 1ml physiological saline and administered intrathecal with bupivacaine before induction of general anesthesia.

Study Type

Interventional

Enrollment (Actual)

90

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

28 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- major abdominal cancer surgery (e.g. hemi-colectomy or cystectomy)

Exclusion Criteria:

  • known allergy to study drugs
  • Significant cardiac, respiratory, renal or hepatic disease.
  • 2nd or 3rd degree heart block.
  • Coagulation disorders.
  • Low back pain or other back problems.
  • Drug or alcohol abuse.
  • BMI>30kg\m2.
  • Psychiatric illnesses that would 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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intrathecal Bupivacaine
intrathecal injection of 10 mg hyperbaric bupivacaine 0.5% in 2 ml volume and 1ml of saline 0.9%
Drug: Bupivacaine
intrathecal 10 mg bupivacaine
Other Names:
  • Buvicaine
Active Comparator: Intrathecal Morphine
intrathecal injection of 10mg bupivacaine 0.5% in 2ml volume intrathecal injection of 0.5 mg morphine in 1ml volume
Drug: Bupivacaine
intrathecal 10 mg bupivacaine
Other Names:
  • Buvicaine
Drug: Morphine
intrathecal 0.5mg morphine
Other Names:
  • morphine sulphate
Active Comparator: Intrathecal Morphine-Dex
intrathecal 10mg bupivacaine 0.5% in 2 ml volume intrathecal 0.5 mg morphine intrathecal 5 µg of dexmedetomidine in 1ml volume .
Drug: Bupivacaine
intrathecal 10 mg bupivacaine
Other Names:
  • Buvicaine
Drug: Morphine
intrathecal 0.5mg morphine
Other Names:
  • morphine sulphate
Drug: Dexmedetomidine (Precedex)
intrathecal administration
Other Names:
  • Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total dose of intravenous PCA morphine consumption in the first 48 h postoperative
Time Frame: 48 hours
Calculating the cumulative intravenous PCA morphine dose
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Noninvasive blood pressure
Time Frame: 48 hours
non invasive systolic and diastolic blood pressure intra-operative and postoperative in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative.
48 hours
Heart rate
Time Frame: 48 hours
non invasive assessment of heart rate in the 6th, 12th, 18th, 24th, 36th, and 48th postoperative. intraoperative and postoperative
48 hours
peripheral arterial oxygen saturation
Time Frame: 48 hours
assessment of pulse oximetry intraoperative and in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative
48 hours
postoperative VAS scores
Time Frame: 48 hours
assessment of pain scores on admission to surgical intensive care unit and in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative.
48 hours
time to first request for analgesia
Time Frame: 48hours
measuring the time in hours of first request for intravenous PCA morphine
48hours

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Saher AB Mohamed, MD, Assisstant professor in Anesthesia and intensive care department, South Egypt Cancer institute, Assiut university, Egypt
  • Study Director: Hala s Abdel-Ghaffar, MD, Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

April 26, 2015

First Submitted That Met QC Criteria

May 5, 2015

First Posted (Estimate)

May 6, 2015

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IORG0006563/reference. no. 64

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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