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

NCT ID: NCT01117610

Last Updated: 2010-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-04-30

Brief Summary

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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

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

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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epidural injection (group I)

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

Group Type ACTIVE_COMPARATOR

Ropivacaine (epidural injection)

Intervention Type DRUG

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

epidural injection group (group C)

control group will receive no medication preoperatively and during operation

Group Type PLACEBO_COMPARATOR

Placebo (one of medication)

Intervention Type DRUG

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

Interventions

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Placebo (one of medication)

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

Intervention Type DRUG

Ropivacaine (epidural injection)

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

Intervention Type DRUG

Other Intervention Names

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patient in group C will receive none of medication epidural injection

Eligibility Criteria

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Inclusion Criteria

* laminectomy

Exclusion Criteria

* r/o infection
* reoperation
* mental change
* allergy to local anesthetics
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Chung-Ang University Hospital

Principal Investigators

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Kwang-Sup Song, M.D. & Ph.D.

Role: STUDY_DIRECTOR

ChungAng University

Hyun Kang, M.D. & Ph.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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ChungAng University

Seoul, , South Korea

Site Status

Countries

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South Korea

Facility Contacts

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SeongDeok Kim, M.D. & Ph.D.

Role: primary

+82-2-6299-2571

References

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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.

Reference Type DERIVED
PMID: 23467861 (View on PubMed)

Other Identifiers

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ChungAngUH

Identifier Type: -

Identifier Source: org_study_id

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