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Management of Postoperative Pain After Total Knee Replacement.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark J. Spangehl, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01163214
First received: July 14, 2010
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

The purpose of this study is to compare two methods of postoperative pain management in patients undergoing total knee replacement.


Condition Intervention Phase
Postoperative Pain
Knee Replacement Arthroplasty
Drug: Nerve Block
Drug: Periarticular Injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Postoperative Pain After Total Knee Replacement.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Post-Operative Pain [ Time Frame: Afternoon on post-operative Day 1, approximately 14:00 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Afternoon on post-operative Day 1, approximately 14:00 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2 ] [ Designated as safety issue: No ]
    Use of additional narcotic medications (as needed), measured in morphine equivalents.

  • Straight-leg Raise [ Time Frame: Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon ] [ Designated as safety issue: No ]
    Post-operative quadriceps function was measured by the number of participants who could perform a straight-leg raise.

  • Length of Stay in Hospital [ Time Frame: Approximately 2 days after surgery ] [ Designated as safety issue: No ]
    Length of stay data were calculated from the medical record.

  • Number of Subjects Who Experienced Neurological Changes Postoperatively [ Time Frame: 6 weeks postoperative ] [ Designated as safety issue: No ]
    Participants were questioned at the 6 weeks follow-up visit regarding any neurological changes that were not present preoperatively.


Enrollment: 160
Study Start Date: July 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nerve Block
Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.
Drug: Nerve Block
Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.
Other Name: Naropin
Active Comparator: Periarticular Injection
Injection combination prior to skin closure.
Drug: Periarticular Injection
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.
Other Names:
  • Naropin
  • Adrenalin
  • Toradol

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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163214

Locations
United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
Sponsors and Collaborators
Mark J. Spangehl, M.D.
Investigators
Principal Investigator: Mark J Spangehl, M.D. Mayo Clinic
  More Information

Publications:
Responsible Party: Mark J. Spangehl, M.D., Associate Professor of Orthopedics, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01163214     History of Changes
Other Study ID Numbers: 10-003312, UL1TR000135
Study First Received: July 14, 2010
Results First Received: October 30, 2014
Last Updated: November 3, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014