A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Ropivacaine (epidural injection); Drug: Placebo (one of medication)

Study type: Interventional

Funder types: Other

Identifiers

NCT01117610

ChungAngUH

Details and patient eligibility

About

This prospective randomized study aims to evaluate the effectiveness of epidural injection of ropivacaine on the relief of pain in patients undergoing laminectomy.

Total 60 patients will be randomized into one of two groups (groupC or groupI) based on Excel number generation.

Patients in group C will receive no medication intraoperatively, and patients in group I will receive epidural injection of 0.1% ropivacaine 10ml before skin incision.

Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4,12,24,48 hour postoperatively.

Full description

Patients in group I will receive 0.1% ropivacaine 10 ml before skin incision under guide of C-arm.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• laminectomy

Exclusion criteria

• r/o infection
• reoperation
• mental change
• allergy to local anesthetics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

epidural injection (group I)

Active Comparator group

Description:

patients in Group I will receive epidural injection of 0.1% ropivacaine 10 ml before skin incision.

Treatment:

Drug: Ropivacaine (epidural injection)

epidural injection group (group C)

Placebo Comparator group

Description:

control group will receive no medication preoperatively and during operation

Treatment:

Drug: Placebo (one of medication)