Postoperative Epidural Analgesia in Spine Fusion Surgery

Pain Clinical Trial

Official title:

Postoperative Epidural Analgesia in Spine Fusion Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01838707
• Other study ID #: 1976
• Status: Completed
• Phase: Phase 2
• First received: April 20, 2013
• Last updated: April 24, 2013
• Start date: December 2007
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	beta-endorphin	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	Yes
Primary	Assessment of pain	• 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	No
Secondary	assessment of patients' satisfaction	verbal rating score will be used (4 = very satisfied, 3 = satisfied, 2 = neutral, 1 = dissatisfied, and 0 = very dissatisfied).	First 3 postoperative days	No