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Clinical Trials/NCT01838707
NCT01838707
Completed
Phase 2

Postoperative Epidural Analgesia in Spine Fusion Surgery

Assiut University1 site in 1 country60 target enrollmentDecember 2007

Overview

Phase
Phase 2
Intervention
0.125% Bupivacaine HCL @ 4-5 ml/h
Conditions
Pain
Sponsor
Assiut University
Enrollment
60
Locations
1
Primary Endpoint
Assessment of pain
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 2007
End Date
March 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Omnia Askar

assistant lecturer of anesthesia and ICU, Assiut University

Assiut University

Eligibility Criteria

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.

Arms & Interventions

Bupivacaine

0.125% Bupivacaine HCL @ 4-5 ml/h

Intervention: 0.125% Bupivacaine HCL @ 4-5 ml/h

Bupivacaine, Morphine

0.125% Bupivacaine HCL , Morphine sulphate 3 mg @ 3-5 ml/h

Intervention: 0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h

Bupivacaine, Fentanyl

0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h

Intervention: 0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • assessment of patients' satisfaction(First 3 postoperative days)

Study Sites (1)

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