Clinical trial NCT01163214: Management of Postoperative Pain After Total Knee Replacement.
Official title: Prospective Randomized Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Postoperative Pain After Total Knee Replacement.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Knee Replacement Arthroplasty
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-07-15
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Post-Operative Pain
timeFrame: Afternoon on post-operative Day 1, approximately 14:00
Secondary outcomes:
measure: Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment)
timeFrame: Afternoon on post-operative Day 1, approximately 14:00
measure: Narcotic Use
timeFrame: Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2
measure: Straight-leg Raise
timeFrame: Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon
measure: Length of Stay in Hospital
timeFrame: Approximately 2 days after surgery
measure: Number of Subjects Who Experienced Neurological Changes Postoperatively
timeFrame: 6 weeks postoperative
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Mark J Spangehl, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spangehl MJ, Clarke HD, Hentz JG, Misra L, Blocher JL, Seamans DP. The Chitranjan Ranawat Award: Periarticular injections and femoral & sciatic blocks provide similar pain relief after TKA: a randomized clinical trial. Clin Orthop Relat Res. 2015 Jan;473(1):45-53. doi: 10.1007/s11999-014-3603-0.