Intraoperative Direct vs Postoperative Ultrasound Guided Adductor Canal Nerve Block After Total Knee Arthroplasty

Intraoperative Direct Adductor Canal Nerve Block Versus Post Operative Ultrasound Guided Adductor Canal Nerve Block in Total Knee Arthroplasty: a Double-blind Randomized Trial

This study compares analgesic effect between two techniques of adductor canal nerve block after total knee arthroplasty. The first group of the patients will receive intraoperative adductor canal nerve block; and the other group post operative ultrasound guided adductor canal nerve block. Investigators will measure postoperative opioid consumption, pain management and rehabilitation goals.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Total Knee Arthroplasty; Nerve Block
• Intervention / Treatment: Procedure: Intraoperative Block; Procedure: Ultrasound Placebo; Procedure: Ultrasound Block; Procedure: Intraoperative Placebo

Detailed Description

Total knee arthroplasty (TKA) is a successful alternative to treat late stage knee osteoarthritis (OA). Pain management has been one of the main focuses of postoperative care. Most surgeons prefer a comprehensive multimodal approach including preoperative pharmacological treatment, intraoperative infiltration with complex drug mixes and postoperative peripheral nerve block.

The most common postoperative nerve block alternative is the proximal femoral nerve block (FNB) which has shown improvements on postoperative pain measured by reduced opioid consumption and decreased pain at rest. Its main detractors argue that the motor nerve block effect is deleterious to early ambulation and have promoted adductor canal nerve blocks (ACB). Described by Lund et al in 2011, ACB block main femoral pain sensory contributors to the knee (articular branches of obturator nerve, vastus medialis branch and saphenous nerve) but is more distal to most motor branches to the quadriceps allowing near to normal quadriceps strength.

Standard ACB block is performed under ultrasound guidance after surgery completion, still in the operating room (OR). Recent literature has shown the anatomic feasibility of intraoperative ACB via blunt suprapatellar dissection in standard medial parapatellar TKA approaches. The study seeks to determine the effectiveness of standard ultrasound guidance ACB compared with intraoperative ACB.

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Región Metropolitana
    • Santiago, Región Metropolitana, Chile, 8330024
      • Pontificia Universidad Catolica de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Primary total knee arthroplasty
• Unilateral
• American Society of Anesthesiologists (ASA) score I, II or III
• Accepts spinal anesthesia

Exclusion Criteria:

• General anesthesia
• Chronic kidney disease
• Drug or alcohol abuse
• Chronic opioid use
• Allergic to bupivacaine or similar

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraoperative Block; Before skin closure, blunt suprapatellar dissection proximal to medial femoral condyle towards adductor canal. Nerve block at this level with 20ml of Bupivacaine 0.25%. Postoperatively, mid-thigh ultrasound guided standard adductor canal nerve block with 20ml of saline solution (NaCl 0.9%).	Procedure: Intraoperative Block; One shot adductor canal nerve block with 20ml of bupivacaine 0.25% through surgical incision; Procedure: Ultrasound Placebo; One shot adductor canal nerve infusion with 20ml of saline solution mid-thigh
Active Comparator: Ultrasound Block; Before skin closure, blunt suprapatellar dissection proximal to medial femoral condyle towards adductor canal. Nerve block at this level with 20ml of of saline solution (NaCl 0.9%). Postoperatively, mid-thigh ultrasound guided standard adductor canal nerve block with 20ml Bupivacaine 0.25%.	Procedure: Ultrasound Block; One shot adductor canal nerve block with 20ml of bupivacaine 0.25% mid-thigh; Procedure: Intraoperative Placebo; One shot adductor canal nerve infusion with 20ml of saline solution through surgical incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hour opioid consumption	Opioid consumption by patient controlled analgesia (PCA) and any other oral or IV analgesics	First 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 patient reported pain	Patient reported pain scale using visual analog scale (VAS) every 6 hours after surgery (0 hours, 6 hours, 12 hours, 18 hours and 24 hours)	First 24 hours after surgery
Time up and go Test	Standardised test to determine patients ability to walk 24 hours after surgery	24 hours after surgery
Time to Discharge	Time between surgery and patient in conditions for discharge: no IV requirements, basic walking capability and VAS pain score equal or below 3	7 days
Range of motion	Active and passive knee range of motion	24 hours after surgery

Collaborators and Investigators

• Sponsor: Pontificia Universidad Catolica de Chile
• Investigators: Principal Investigator: Pablo Besa, Pontificia Universidad Catolica de Chile

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Actual): May 12, 2022
• Study Completion (Actual): October 24, 2022

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 180620002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No