Postoperative Epidural Analgesia in Spine Fusion Surgery

NCT ID: NCT01838707

Last Updated: 2013-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2013-03-31

Brief Summary

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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

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Bupivacaine

0.125% Bupivacaine HCL @ 4-5 ml/h

Group Type ACTIVE_COMPARATOR

0.125% Bupivacaine HCL @ 4-5 ml/h

Intervention Type DRUG

Bupivacaine, Morphine

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Bupivacaine, Fentanyl

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Interventions

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0.125% Bupivacaine HCL @ 4-5 ml/h

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Omnia Askar

assistant lecturer of anesthesia and ICU, Assiut University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omnia A Abd El Raof, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Assiut University Hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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1976

Identifier Type: -

Identifier Source: org_study_id

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