A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Placebo (one of medication)
Ropivacaine (epidural injection)
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring pain, preemptive, postoperative, epidural injection, laminectomy
Eligibility Criteria
Inclusion Criteria:
- laminectomy
Exclusion Criteria:
- r/o infection
- reoperation
- mental change
- allergy to local anesthetics
Sites / Locations
- ChungAng University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
epidural injection (group I)
epidural injection group (group C)
Arm Description
patients in Group I will receive epidural injection of 0.1% ropivacaine 10 ml before skin incision.
control group will receive no medication preoperatively and during operation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
visual analogue scale 24hour
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
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
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
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
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
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
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
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
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
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
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.
Full Information
NCT ID
NCT01117610
First Posted
May 4, 2010
Last Updated
May 4, 2010
Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01117610
Brief Title
A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery
Official Title
A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery: A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
April 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
pain, preemptive, postoperative, epidural injection, laminectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
epidural injection (group I)
Arm Type
Active Comparator
Arm Description
patients in Group I will receive epidural injection of 0.1% ropivacaine 10 ml before skin incision.
Arm Title
epidural injection group (group C)
Arm Type
Placebo Comparator
Arm Description
control group will receive no medication preoperatively and during operation
Intervention Type
Drug
Intervention Name(s)
Placebo (one of medication)
Other Intervention Name(s)
patient in group C will receive none of medication
Intervention Description
patients in Group C will receive none of medication preoperatively and intraoperatively
Intervention Type
Drug
Intervention Name(s)
Ropivacaine (epidural injection)
Other Intervention Name(s)
epidural injection
Intervention Description
patient in group I will receive epidural injection of 0.1% ropivacaine 10ml before skin incision.
Primary Outcome Measure Information:
Title
Visual analogue scale 4hour
Description
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.
Time Frame
post op 4hour
Secondary Outcome Measure Information:
Title
visual analogue scale 24hour
Description
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.
Time Frame
Post Op 24 hour
Title
visual analogue scale 12 hour
Description
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.
Time Frame
Post op 12 hour
Title
Visual analogue scale 48hour
Description
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.
Time Frame
Post Op 48hour
Title
Opioid consumption 4hour
Description
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.
Time Frame
Post Op 4hour
Title
Opioid consumption 24hour
Description
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.
Time Frame
Post op 24 hour
Title
Opioid consumption 12 hour
Description
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.
Time Frame
Post Op 12 hour
Title
Opioid consumption 48hour
Description
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
Time Frame
Post Op 48 hour
Title
FPB 4 hour
Description
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.
Time Frame
Post Op 4 hour
Title
FPB 12 hour
Description
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.
Time Frame
post op 12 hour
Title
FPB 24 hour
Description
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.
Time Frame
Post Op 24 hour
Title
FPB 48 hour
Description
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.
Time Frame
Post Op 48 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
laminectomy
Exclusion Criteria:
r/o infection
reoperation
mental change
allergy to local anesthetics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwang-Sup Song, M.D. & Ph.D.
Organizational Affiliation
ChungAng University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hyun Kang, M.D. & Ph.D.
Organizational Affiliation
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
ChungAng University
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SeongDeok Kim, M.D. & Ph.D.
Phone
+82-2-6299-2571
Email
ksdeok@cau.ac.kr
12. IPD Sharing Statement
Citations:
PubMed Identifier
23467861
Citation
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.
Results Reference
derived
Learn more about this trial
A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery
We'll reach out to this number within 24 hrs