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Completed

NCT Number: NCT01163214

Management of Postoperative Pain After Total Knee Replacement.

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

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Key information

Conditions

Postoperative Pain Knee Replacement Arthroplasty Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic

Phoenix, Arizona, 85054, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nerve block

Drug

Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.

Other names: Naropin

Periarticular Injection

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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.

  3. 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.

  4. Length of Stay in Hospital

    Time frame: Approximately 2 days after surgery

    Length of stay data were calculated from the medical record.

  5. 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.

Sponsors and collaborators

Lead sponsor

Mark J. Spangehl, M.D.

Other

Registry information

Official study title

Prospective Randomized Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Postoperative Pain After Total Knee Replacement.

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 15, 2010
Registry last updated
Nov 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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