Postoperative Epidural Analgesia in Spine Fusion Surgery

April 24, 2013 updated by: Omnia Askar, Assiut University
we aim to compare the analgesic effect of 0.125% bupivacaine HCL, 0.125% bupivacaine HCL + Morphine sulphate 3 mg, 0.125% bupivacaine HCL + Fentanyl 100 micro gram both at rest and mobilization maneuvers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Assiut university hospital

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

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing spine fusion surgery.

Exclusion Criteria:

  • Drug addiction. Intraoperative dural tear. Uses of opioids drug for any reason in the previous 48 hours. Mental dysfunction. Spinal fusion for any infectious or malignant causes.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Bupivacaine
0.125% Bupivacaine HCL @ 4-5 ml/h
Drug: 0.125% Bupivacaine HCL @ 4-5 ml/h
ACTIVE_COMPARATOR: Bupivacaine, Morphine
0.125% Bupivacaine HCL , Morphine sulphate 3 mg @ 3-5 ml/h
Drug: 0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h
ACTIVE_COMPARATOR: Bupivacaine, Fentanyl
0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h
Drug: 0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of pain
Time Frame: first 3 postoperative days
• Pain will be assessed using the VAS ranging from "0" (no pain) to "10" (worst imaginable pain). Pain will be evaluated at rest, while coughing, and during mobilization. Maneuvers of particular clinical importance for postoperative mobilization (alone and with help) will be chosen: Turning in bed, standing in front of the bed and walking, and using the toilet without help. The time needed until the patient can first successfully perform these maneuvers will be documented.
first 3 postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of patients' satisfaction
Time Frame: First 3 postoperative days
verbal rating score will be used (4 = very satisfied, 3 = satisfied, 2 = neutral, 1 = dissatisfied, and 0 = very dissatisfied).
First 3 postoperative days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
beta-endorphin
Time Frame: 1st postoperative day
3 serum samples for beta-endorphin will be taken 1st one preoperative base line , 2nd at VAS more than 3 at rest ,3rd when VAS less than 2 at rest
1st postoperative day

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Omnia A Abd El Raof, M.Sc., 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, 2007

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

April 20, 2013

First Submitted That Met QC Criteria

April 23, 2013

First Posted (ESTIMATE)

April 24, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 25, 2013

Last Update Submitted That Met QC Criteria

April 24, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1976

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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