Postoperative Epidural Analgesia in Spine Fusion Surgery

Phase 2

Completed

• Conditions: Pain
• Interventions: Drug: 0.125% Bupivacaine HCL @ 4-5 ml/h; Drug: 0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h; Drug: 0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h

• Registration Number: NCT01838707
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-04
• Study First Submitted: 2013-04-20
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-24
• Last Update Submitted: 2013-04-24
• Last Update Posted: 2013-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine	0.125% Bupivacaine HCL @ 4-5 ml/h	0.125% Bupivacaine HCL @ 4-5 ml/h
Bupivacaine, Morphine	0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h	0.125% Bupivacaine HCL , Morphine sulphate 3 mg @ 3-5 ml/h
Bupivacaine, Fentanyl	0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h	0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h

Primary Outcome Measures

Name	Time	Method
Assessment of pain	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 Outcome Measures

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

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt