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Management of Postoperative Pain After Total Knee Replacement.

M

Mark J. Spangehl, M.D.

Status and phase

Completed
Phase 4

Conditions

Postoperative Pain
Knee Replacement Arthroplasty

Treatments

Drug: Periarticular Injection
Drug: Nerve Block

Study type

Interventional

Funder types

Other

Identifiers

NCT01163214
10-003312
UL1TR000135 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

160 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

Nerve Block
Experimental group
Description:
Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.
Treatment:
Drug: Nerve Block
Periarticular Injection
Active Comparator group
Description:
Injection combination prior to skin closure.
Treatment:
Drug: Periarticular Injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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