Ultrasound-guided Adductor Canal Block for Total Knee Replacement

NCT02100579 | Completed Phase 4 Results

• 1 other identifier: STU00088239
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Complications; Arthroplasty; Knee Injuries

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption (mg morEq)

  Opioid consumption (morphine equivalents)

  36 hours

Secondary Outcomes (2)

• Visual Analog Scale Pain Score

  Pain burden at 36hr

• Length of Hospitalization

  0 to 192 hours

Study Arms (2)

Active Group

ACTIVE COMPARATOR

Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine

Drug: Bupivacaine

Control Group

PLACEBO COMPARATOR

Ultrasound-guided sham block with 10 ml of preservative free normal saline

Drug: Preservative free normal saline

Interventions

Bupivacaine DRUG

10 ml of 0.25% bupivacaine

Also known as: Sensorcaine

Active Group

Preservative free normal saline DRUG

10 ml of preservative free normal saline

Also known as: 0.9% sodium chloride

Control Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Knee Injuries

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Antoun Nader
• Organization: Northwestern University, Feinberg School of Medicine

a-nader2@northwestern.edu

312-695-3045

Study Officials

• Antoun Nader, MD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: April 1, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 11, 2017
• Results First Posted: November 2, 2016

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)