A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery: A Prospective Randomized Study
Overview
- Phase
- Phase 4
- Intervention
- Ropivacaine (epidural injection)
- Conditions
- Postoperative Pain
- Sponsor
- Chung-Ang University Hosptial, Chung-Ang University College of Medicine
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Visual analogue scale 4hour
- Last Updated
- 16 years ago
Overview
Brief Summary
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.
Detailed Description
Patients in group I will receive 0.1% ropivacaine 10 ml before skin incision under guide of C-arm.
Investigators
Eligibility Criteria
Inclusion Criteria
- •laminectomy
Exclusion Criteria
- •r/o infection
- •reoperation
- •mental change
- •allergy to local anesthetics
Arms & Interventions
epidural injection (group I)
patients in Group I will receive epidural injection of 0.1% ropivacaine 10 ml before skin incision.
Intervention: Ropivacaine (epidural injection)
epidural injection group (group C)
control group will receive no medication preoperatively and during operation
Intervention: Placebo (one of medication)
Outcomes
Primary Outcomes
Visual analogue scale 4hour
Time Frame: post op 4hour
Patients will be assessed for pain using a visual analogue pain scale (VAS). It is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end; left side end which represents 0 is 'No pain', right side end with 100 is 'Very severe pain'. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. To check the severity of pain VAS will be measured at post op 4hour.
Secondary Outcomes
- visual analogue scale 24hour(Post Op 24 hour)
- visual analogue scale 12 hour(Post op 12 hour)
- Visual analogue scale 48hour(Post Op 48hour)
- Opioid consumption 4hour(Post Op 4hour)
- Opioid consumption 24hour(Post op 24 hour)
- Opioid consumption 12 hour(Post Op 12 hour)
- Opioid consumption 48hour(Post Op 48 hour)
- FPB 4 hour(Post Op 4 hour)
- FPB 12 hour(post op 12 hour)
- FPB 24 hour(Post Op 24 hour)
- FPB 48 hour(Post Op 48 hour)