Ultrasound-guided Adductor Canal Block for Total Knee Replacement

Phase 4

Completed

• Conditions: Knee Injuries; Complications; Arthroplasty
• Interventions: Drug: Preservative free normal saline; Drug: Bupivacaine

• Registration Number: NCT02100579
• Lead Sponsor: Northwestern University

Brief Summary

Total knee arthroplasty is associated with intense early postoperative pain. Fast track recovery programs including early therapy protocols and early hospital discharge are being implemented at various hospitals. The postoperative analgesic pain regimen should enhance functional recovery in addition to providing efficient analgesia with minimal side effects. Adductor canal blockade is commonly used to provide postoperative analgesia for total knee arthroplasty (TKA) surgery. The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.

Detailed Description

The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-25
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-04-01
• Primary Completion: 2015-10
• Study Completion: 2015-12
• Results First Submitted: 2016-09-14
• Results First Submitted QC: 2016-09-14
• Results First Posted: 2016-11-02
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-14
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Participants 40 to 75 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia

Exclusion Criteria

• Patient refusal
• American Society of Anesthesiologists physical status classification of 4 or higher
• Pre-existing neuropathy in the femoral or sciatic distribution
• Coagulopathy
• Infection at the site
• Chronic opioid use (greater than 3 months)
• Pregnancy
• Medical conditions limiting physical therapy participation
• Any other contra-indication to regional anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Preservative free normal saline	Ultrasound-guided sham block with 10 ml of preservative free normal saline
Active Group	Bupivacaine	Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine

Primary Outcome Measures

Name	Time	Method
Opioid Consumption (mg morEq)	36 hours	Opioid consumption (morphine equivalents)

Secondary Outcome Measures

Name	Time	Method
Length of Hospitalization	0 to 192 hours	The average time to discharge in hours. Participants were discharged home went physical therapy criteria were met.
Visual Analog Scale Pain Score	Pain burden at 36hr	Visual Analog Scale pain score; 0 = no pain, 10 = excruciating pain) in the knee recorded every 6 hours up to 36hrs following surgery.

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States