A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery: A Prospective Randomized Study

NCT01117610 Phase 4 UNKNOWN

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.

Details

Lead sponsor	Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Phase	Phase 4
Status	UNKNOWN
Enrolment	60
Start date	2010-05
Completion	2011-04

Conditions

• Postoperative Pain

Interventions

• Placebo (one of medication)
• Ropivacaine (epidural injection)

Primary outcomes

• Visual analogue scale 4hour — 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.

Countries

South Korea