Management of Postoperative Pain After Total Knee Replacement.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01163214
First received: July 14, 2010
Last updated: November 26, 2013
Last verified: November 2013
  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
Total Knee Replacement
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:
  • Pain [ Time Frame: 14:00 on post-operative Day 1 ] [ Designated as safety issue: No ]
    Linear analog scale score for pain on a scale from 0 to 10 points.


Estimated Enrollment: 150
Study Start Date: July 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (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.
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.

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
Mayo Clinic
Investigators
Principal Investigator: Mark J Spangehl, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Mark J Spangehl, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01163214     History of Changes
Other Study ID Numbers: 10-003312
Study First Received: July 14, 2010
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 20, 2014