Ultrasound-guided Adductor Canal Block for Total Knee Replacement

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

Ultrasound-guided Adductor Canal Block for Total Knee Replacement: a Randomized, Double-blind Placebo Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02100579
• Other study ID #: STU00088239
• Secondary ID: STU00088239
• Status: Recruiting
• Phase: Phase 4
• First received: March 25, 2014
• Last updated: October 1, 2015
• Start date: March 2014

Study information

• Verified date: October 2015
• Source: Northwestern University
• Contact: Mark Kendall, MD
• Phone: 312-695-2528
• Email: m-kendall[@]northwestern.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Drug:
• Bupivacaine
10 ml of 0.25% bupivacaine
• Preservative free normal saline
10 ml of preservative free normal saline

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption		72 hours	Yes
Secondary	Visual Analog Scale pain score	Visual Analog Scale pain score; 0 = no pain, 10 = excruciating pain) in the knee at rest and during activity recorded every 4 hours up to 48hrs following surgery.	4hr intervals up to 48hrs	No
Secondary	Length of hospitalization		24 to 72 hrs	No