Back to resultsManagement of Postoperative Pain After Total Knee Replacement.
Primary Purpose
Postoperative Pain, Knee Replacement Arthroplasty
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nerve Block
Periarticular Injection
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Unilateral primary total knee replacement.
- Weight 50-125 kg.
- Age 18-79 years.
- Intact neurological exam to the surgical lower extremity.
- Cognitively intact with ability to sign informed consent.
Exclusion Criteria:
- Renal insufficiency with creatinine >1.5 mg/dL.
- Allergy to medication used in the study.
- Using narcotic medication prior to surgery (morphine equivalents >=20 mg/day for >7 days.)
- Prior open knee surgery with regional anesthesia or periarticular injection for post-operative pain management.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nerve Block
Periarticular Injection
Arm Description
Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.
Injection combination prior to skin closure.
Outcomes
Primary Outcome Measures
Post-Operative Pain
Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).
Secondary Outcome Measures
Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment)
Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).
Narcotic Use
Use of additional narcotic medications (as needed), measured in morphine equivalents.
Straight-leg Raise
Post-operative quadriceps function was measured by the number of participants who could perform a straight-leg raise.
Length of Stay in Hospital
Length of stay data were calculated from the medical record.
Number of Subjects Who Experienced Neurological Changes Postoperatively
Participants were questioned at the 6 weeks follow-up visit regarding any neurological changes that were not present preoperatively.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01163214
Brief Title
Management of Postoperative Pain After Total Knee Replacement.
Official Title
Prospective Randomized Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Postoperative Pain After Total Knee Replacement.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mark J. Spangehl, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare two methods of postoperative pain management in patients undergoing total knee replacement.
Detailed Description
Patients undergoing total knee replacement will be assigned at random to receive one of two methods of postoperative pain management. Patients assigned to nerve block will receive regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block. Patients assigned to periarticular injection will receive periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Additionally, all patients will be given a standardized combination of oral analgesic medications preoperatively and postoperatively. All patients will receive a posterior stabilized total knee replacement through an medial parapatellar approach.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Knee Replacement Arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nerve Block
Arm Type
Experimental
Arm Description
Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.
Arm Title
Periarticular Injection
Arm Type
Active Comparator
Arm Description
Injection combination prior to skin closure.
Intervention Type
Drug
Intervention Name(s)
Nerve Block
Other Intervention Name(s)
Naropin
Intervention Description
Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.
Intervention Type
Drug
Intervention Name(s)
Periarticular Injection
Other Intervention Name(s)
Naropin, Adrenalin, Toradol
Intervention Description
Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.
Primary Outcome Measure Information:
Title
Post-Operative Pain
Description
Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).
Time Frame
Afternoon on post-operative Day 1, approximately 14:00
Secondary Outcome Measure Information:
Title
Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment)
Description
Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).
Time Frame
Afternoon on post-operative Day 1, approximately 14:00
Title
Narcotic Use
Description
Use of additional narcotic medications (as needed), measured in morphine equivalents.
Time Frame
Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2
Title
Straight-leg Raise
Description
Post-operative quadriceps function was measured by the number of participants who could perform a straight-leg raise.
Time Frame
Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon
Title
Length of Stay in Hospital
Description
Length of stay data were calculated from the medical record.
Time Frame
Approximately 2 days after surgery
Title
Number of Subjects Who Experienced Neurological Changes Postoperatively
Description
Participants were questioned at the 6 weeks follow-up visit regarding any neurological changes that were not present preoperatively.
Time Frame
6 weeks postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral primary total knee replacement.
Weight 50-125 kg.
Age 18-79 years.
Intact neurological exam to the surgical lower extremity.
Cognitively intact with ability to sign informed consent.
Exclusion Criteria:
Renal insufficiency with creatinine >1.5 mg/dL.
Allergy to medication used in the study.
Using narcotic medication prior to surgery (morphine equivalents >=20 mg/day for >7 days.)
Prior open knee surgery with regional anesthesia or periarticular injection for post-operative pain management.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J Spangehl, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24706022
Citation
Spangehl MJ, Clarke HD, Hentz JG, Misra L, Blocher JL, Seamans DP. The Chitranjan Ranawat Award: Periarticular injections and femoral & sciatic blocks provide similar pain relief after TKA: a randomized clinical trial. Clin Orthop Relat Res. 2015 Jan;473(1):45-53. doi: 10.1007/s11999-014-3603-0.
Results Reference
result
Learn more about this trial
Management of Postoperative Pain After Total Knee Replacement.
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