Skip to main content
OpenTrials
Completed

NCT Number: NCT01838707

Postoperative Epidural Analgesia in Spine Fusion Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Assiut University Hospital

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Primary outcomes

  1. 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

  1. 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).

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Apr 24, 2013
Registry last updated
Apr 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.