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

NCT01117610 | Unknown Phase 4

• 1 other identifier: ChungAngUH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

pain; preemptive; postoperative; epidural injection; laminectomy

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale 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.

  post op 4hour

Secondary Outcomes (11)

• 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

Study Arms (2)

epidural injection (group I)

ACTIVE COMPARATOR

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

Drug: Ropivacaine (epidural injection)

epidural injection group (group C)

PLACEBO COMPARATOR

control group will receive no medication preoperatively and during operation

Drug: Placebo (one of medication)

Interventions

Placebo (one of medication) DRUG

patients in Group C will receive none of medication preoperatively and intraoperatively

Also known as: patient in group C will receive none of medication

epidural injection group (group C)

Ropivacaine (epidural injection) DRUG

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

Also known as: epidural injection

epidural injection (group I)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• laminectomy

You may not qualify if:

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

Sponsors & Collaborators

• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: lead

Study Sites (1)

ChungAng University

Seoul, 156-755, South Korea

Location

Related Publications (1)

• Kang H, Jung HJ, Lee JS, Yang JJ, Shin HY, Song KS. Early postoperative analgesic effects of a single epidural injection of ropivacaine administered preoperatively in posterior lumbar interbody spinal arthrodesis: a pilot randomized controlled trial. J Bone Joint Surg Am. 2013 Mar 6;95(5):393-9. doi: 10.2106/JBJS.K.01729.

  PMID: 23467861 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Ropivacaine; Injections, Epidural

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Kwang-Sup Song, M.D. & Ph.D.

  ChungAng University

  STUDY DIRECTOR

• Hyun Kang, M.D. & Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 5, 2010
• Study Start: May 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 5, 2010

Record last verified: 2010-05

Locations

KR (1)