Postoperative Epidural Analgesia in Spine Fusion Surgery

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01838707

Enrollment

Registered

2013-04-24

Start date

2007-12-31

Completion date

2013-03-31

Last updated

2013-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

postoperative, spine surgery

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.

Interventions

DRUG0.125% Bupivacaine HCL @ 4-5 ml/h

DRUG0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h

DRUG0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Other

Measure	Time frame	Description
beta-endorphin	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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026