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Management of Postoperative Pain After Total Knee Replacement.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01163214
First Posted: July 15, 2010
Last Update Posted: November 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mark J. Spangehl, M.D., Mayo Clinic
  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
Intervention Model: Parallel Assignment
Masking: None (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 Mark J. Spangehl, M.D., Mayo Clinic:

Primary Outcome Measures:
  • Post-Operative Pain [ Time Frame: Afternoon on post-operative Day 1, approximately 14:00 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Length of stay data were calculated from the medical record.

  • Number of Subjects Who Experienced Neurological Changes Postoperatively [ Time Frame: 6 weeks postoperative ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( U.S. NIH Grant/Contract )
First Submitted: July 14, 2010
First Posted: July 15, 2010
Results First Submitted: October 30, 2014
Results First Posted: November 5, 2014
Last Update Posted: November 5, 2014
Last Verified: November 2014

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