Completed
Postoperative Epidural Analgesia in Spine Fusion Surgery
What is being tested
0.125% Bupivacaine HCL @ 4-5 ml/h
+ 0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h
+ 0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h
Drug
Who is being recruted
Neurologic Manifestations+1
+ Signs and Symptoms
+ Pathological Conditions, Signs and Symptoms
From 18 to 60 Years
+2 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: December 2007
Summary
Principal SponsorAssiut University
Last updated: April 25, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2007
Actual date on which the first participant was enrolled.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.
Principal SponsorAssiut University
Last updated: April 25, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPain
Criteria
1 inclusion criteria required to participate
patients undergoing spine fusion surgery
1 exclusion criteria prevent from participating
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
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active Comparator0.125% Bupivacaine HCL @ 4-5 ml/h
Group II
Active Comparator0.125% Bupivacaine HCL , Morphine sulphate 3 mg @ 3-5 ml/h
Group III
Active Comparator0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center