Postoperative Epidural Analgesia in Spine Fusion Surgery

Assiut University

Status and phase: Completed; Phase 2

Conditions: Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01838707

1976

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Bupivacaine

Active Comparator group

Description:

0.125% Bupivacaine HCL @ 4-5 ml/h

Treatment:

Drug: 0.125% Bupivacaine HCL @ 4-5 ml/h

Bupivacaine, Morphine

Active Comparator group

Description:

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

Treatment:

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

Bupivacaine, Fentanyl

Active Comparator group

Description:

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

Treatment:

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