Management of Postoperative Pain After Total Knee Replacement.

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163214
• Other study ID #: 10-003312
• Secondary ID: UL1TR000135
• Status: Completed
• Phase: Phase 4
• First received: July 14, 2010
• Last updated: November 3, 2014
• Start date: July 2010
• Est. completion date: June 2013

Study information

• Verified date: November 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Replacement Arthroplasty
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Nerve Block
Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mark J. Spangehl, M.D.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-Operative Pain	Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).	Afternoon on post-operative Day 1, approximately 14:00	No
Secondary	Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment)	Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).	Afternoon on post-operative Day 1, approximately 14:00	No
Secondary	Narcotic Use	Use of additional narcotic medications (as needed), measured in morphine equivalents.	Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2	No
Secondary	Straight-leg Raise	Post-operative quadriceps function was measured by the number of participants who could perform a straight-leg raise.	Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon	No
Secondary	Length of Stay in Hospital	Length of stay data were calculated from the medical record.	Approximately 2 days after surgery	No
Secondary	Number of Subjects Who Experienced Neurological Changes Postoperatively	Participants were questioned at the 6 weeks follow-up visit regarding any neurological changes that were not present preoperatively.	6 weeks postoperative	No