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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Chung-Ang University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Chung-Ang University Hospital
ClinicalTrials.gov Identifier:
NCT01117610
First received: May 4, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
 Drug: Placebo (one of medication)
Drug: Ropivacaine (epidural injection)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery: A Prospective Randomized Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chung-Ang University Hospital:

Primary Outcome Measures:
  • Visual analogue scale 4hour [ Time Frame: post op 4hour ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • visual analogue scale 24hour [ Time Frame: Post Op 24 hour ] [ Designated as safety issue: No ]

    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 24hour.


  • visual analogue scale 12 hour [ Time Frame: Post op 12 hour ] [ Designated as safety issue: No ]

    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 12 hour.


  • Visual analogue scale 48hour [ Time Frame: Post Op 48hour ] [ Designated as safety issue: No ]

    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 48 hour.


  • Opioid consumption 4hour [ Time Frame: Post Op 4hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid fom immediately after operation to post op 4hour will be measured.

  • Opioid consumption 24hour [ Time Frame: Post op 24 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid from 12 hour to post op 24 hour will be measured.

  • Opioid consumption 12 hour [ Time Frame: Post Op 12 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid from post op 4hour to post op 12 hour will be measured.

  • Opioid consumption 48hour [ Time Frame: Post Op 48 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. In the case of persistent pain greater than a visual analogue scale (VAS) pain score of 30 mm, an additional 50 μg of fentanyl will be injected intra-venously by nursing staff until the pain was relieved to a level less than a VAS pain score of 30 mm. And sum of delivery from PCA system and additional opioid from post op 24 hour to post op 48 hour will be measured

  • FPB 4 hour [ Time Frame: Post Op 4 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And total frequency of patient to push the button of the PCA machine (FPB) fom immediately after operation to post op 4 hour will be measured.

  • FPB 12 hour [ Time Frame: post op 12 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And frequency of patient to push the button of the PCA machine (FPB) from post op 4 hour to post op 12 hour will be measured.

  • FPB 24 hour [ Time Frame: Post Op 24 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And frequency of patient to push the button of the PCA machine (FPB) fom post op 12 hour to post op 24 hour will be measured.

  • FPB 48 hour [ Time Frame: Post Op 48 hour ] [ Designated as safety issue: No ]
    The patients will be taught to push the button of the PCA system, which delivered a bolus of drug, each time pain occurred. And frequency of patient to push the button of the PCA machine (FPB) fom post op 24 hour to post op 48 hour will be measured.


Estimated Enrollment: 60
Study Start Date: May 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: epidural injection (group I)
patients in Group I will receive epidural injection of 0.1% ropivacaine 10 ml before skin incision.
 Drug: Ropivacaine (epidural injection)
patient in group I will receive epidural injection of 0.1% ropivacaine 10ml before skin incision.
Other Name: epidural injection
Placebo Comparator: epidural injection group (group C)
control group will receive no medication preoperatively and during operation
 Drug: Placebo (one of medication)
patients in Group C will receive none of medication preoperatively and intraoperatively
Other Name: patient in group C will receive none of medication

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • laminectomy

Exclusion Criteria:

  • r/o infection
  • reoperation
  • mental change
  • allergy to local anesthetics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01117610

Locations
Korea, Republic of
ChungAng University Not yet recruiting
Seoul, Korea, Republic of, 156-755
Contact: SeongDeok Kim, M.D. & Ph.D.     +82-2-6299-2571     ksdeok@cau.ac.kr    
Sponsors and Collaborators
Chung-Ang University Hospital
Investigators
Study Director: Kwang-Sup Song, M.D. & Ph.D. ChungAng University
Principal Investigator: Hyun Kang, M.D. & Ph.D. Chungang University Hospital
  More Information

No publications provided by Chung-Ang University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kwang-Sup Song, Chung-Ang University Hospital
ClinicalTrials.gov Identifier: NCT01117610     History of Changes
Other Study ID Numbers: ChungAngUH
Study First Received: May 4, 2010
Last Updated: May 4, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Chung-Ang University Hospital:
pain
preemptive
postoperative
epidural injection
laminectomy

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013