Continuous Adductor Canal Block in Outpatient Total Knee Arthroplasty

NCT05100706 | Active Not Recruiting

• 1 other identifier: 21-0041-A
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee arthroplasty (TKA) is a frequent performed surgery. Many institutions are implementing outpatient programs for this surgery and adequate pain management is an important feature. Analgesic duration of single shot nerve blocks is limited to no more than 24h. Conversely, the use of continuous nerve block (CNB) through a perineural catheter and infusion of local anesthetic may increase duration of analgesia and provide better outcomes. The purpose of this study is to evaluate effectiveness and safety of using CNB in patients undergoing primary TKA, and its effects on patients' quality of recovery. We hypothesize that continuous adductor canal block would lead to a better quality of recovery in patients undergoing primary TKA.

Conditions

Knee Arthroplasty, Total; Anesthesia, Regional; Acute Pain

Outcome Measures

Primary Outcomes (3)

• Quality of Recovery 15 score (QoR-15)

  Quality of Recovery 15 score (QoR-15): from 0 to 150. Higher scores mean a better outcome.

  Day 1

• Quality of Recovery 15 score (QoR-15)

  Quality of Recovery 15 score (QoR-15): from 0 to 150. Higher scores mean a better outcome.

  Day 2

• Quality of Recovery 15 score (QoR-15)

  Quality of Recovery 15 score (QoR-15): from 0 to 150. Higher scores mean a better outcome.

  Day 3

Secondary Outcomes (9)

• Pain scores

  Day 1

• Pain scores

  Day 2

• Pain scores

  Day 3

• Pain scores

  Day 30

• Opioid usage

  Day 1

Study Arms (2)

Continuous adductor canal block (CACB)

EXPERIMENTAL

Will receive an infusion of 0.2% ropivacaine 5mL/h through adductor canal catheter.

Drug: Continuous adductor canal block (CACB)

Sham continuous adductor canal block (ShACB).

PLACEBO COMPARATOR

Will receive an infusion of NaCl 0.9% 5mL/h through adductor canal catheter.

Drug: Sham continuous adductor canal block (ShACB).

Interventions

Continuous adductor canal block (CACB) DRUG

Ropivacaine 0.2% infusion through adductor canal catheter

Continuous adductor canal block (CACB)

Sham continuous adductor canal block (ShACB). DRUG

NaCl 0.9% infusion through adductor canal catheter

Sham continuous adductor canal block (ShACB).

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing unilateral primary TKA in an outpatient or short-stay setting (estimated discharge on POD#0-1).
• Patients older than 21 years of age.
• American Society of Anesthesiologists (ASA) physical status I-III.
• No alcohol or drug dependency.
• Sufficient understand and co-operation about the perineural catheter.

You may not qualify if:

• Chronic opioid use of morphine 30mg equivalent per day for last 2 consecutive weeks.
• Allergy to the study medications.
• Coagulopathy and platelet count \< 105/μL.
• Patients with contraindications to the insertion of an epidural or adductor canal catheter (severe anatomic abnormalities or history of previous surgery at the site of catheter placement).

Sponsors & Collaborators

• University of Toronto: lead
• MOUNT SINAI HOSPITAL: collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (11)

• Price AJ, Alvand A, Troelsen A, Katz JN, Hooper G, Gray A, Carr A, Beard D. Knee replacement. Lancet. 2018 Nov 3;392(10158):1672-1682. doi: 10.1016/S0140-6736(18)32344-4.

  PMID: 30496082 BACKGROUND

• Cullom C, Weed JT. Anesthetic and Analgesic Management for Outpatient Knee Arthroplasty. Curr Pain Headache Rep. 2017 May;21(5):23. doi: 10.1007/s11916-017-0623-y.

  PMID: 28283810 BACKGROUND

• Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.

  PMID: 20889937 BACKGROUND

• Sharma S, Iorio R, Specht LM, Davies-Lepie S, Healy WL. Complications of femoral nerve block for total knee arthroplasty. Clin Orthop Relat Res. 2010 Jan;468(1):135-40. doi: 10.1007/s11999-009-1025-1. Epub 2009 Aug 13.

  PMID: 19680735 BACKGROUND

• Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.

  PMID: 29721648 BACKGROUND

• Leung P, Dickerson DM, Denduluri SK, Mohammed MK, Lu M, Anitescu M, Luu HH. Postoperative continuous adductor canal block for total knee arthroplasty improves pain and functional recovery: A randomized controlled clinical trial. J Clin Anesth. 2018 Sep;49:46-52. doi: 10.1016/j.jclinane.2018.06.004. Epub 2018 Jun 8.

  PMID: 29890381 BACKGROUND

• Yu R, Wang H, Zhuo Y, Liu D, Wu C, Zhang Y. Continuous adductor canal block provides better performance after total knee arthroplasty compared with the single-shot adductor canal block?: An updated meta-analysis of randomized controlled trials. Medicine (Baltimore). 2020 Oct 23;99(43):e22762. doi: 10.1097/MD.0000000000022762.

  PMID: 33120783 BACKGROUND

• Hanson NA, Lee PH, Yuan SC, Choi DS, Allen CJ, Auyong DB. Continuous ambulatory adductor canal catheters for patients undergoing knee arthroplasty surgery. J Clin Anesth. 2016 Dec;35:190-194. doi: 10.1016/j.jclinane.2016.07.022. Epub 2016 Aug 30.

  PMID: 27871518 BACKGROUND

• Myles PS. More than just morbidity and mortality - quality of recovery and long-term functional recovery after surgery. Anaesthesia. 2020 Jan;75 Suppl 1:e143-e150. doi: 10.1111/anae.14786.

  PMID: 31903564 BACKGROUND

• Sun C, Zhang X, Song F, Zhao Z, Du R, Wu S, Ma Q, Cai X. Is continuous catheter adductor canal block better than single-shot canal adductor canal block in primary total knee arthroplasty?: A GRADE analysis of the evidence through a systematic review and meta-analysis. Medicine (Baltimore). 2020 May;99(20):e20320. doi: 10.1097/MD.0000000000020320.

  PMID: 32443383 BACKGROUND

• Johansson Stark A, Charalambous A, Istomina N, Salantera S, Sigurdardottir AK, Sourtzi P, Valkeapaa K, Zabalegui A, Bachrach-Lindstrom M. The quality of recovery on discharge from hospital, a comparison between patients undergoing hip and knee replacement - a European study. J Clin Nurs. 2016 Sep;25(17-18):2489-501. doi: 10.1111/jocn.13278. Epub 2016 Jun 6.

  PMID: 27264877 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Naveed Siddiqui, MD, MSc

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomized to one of the two groups using a computer-generated random numbers table. The randomization will be done before the beginning of the study and will define which study number is going to be managed as interventional group (continuous adductor canal block - CACB) or control group (sham continuous adductor canal block - ShACB). Each patient will receive a study number following the order of their entrance on the study. The elastomeric pumps to be used connected to the catheter will be previously prepared by hospital pharmacy, accordingly to the randomization made and the subject study number, with no identification of the content (NaCl 0.9% or Ropivacaine 0.2%). Hospital pharmacy will not be blinded for which study number and elastomeric pump will be linked to the study group. Research coordinator, professional who performs the adductor canal catheter insertion and researcher who collects the data will be blinded to which group each patient was randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled prospective trial, blinded for patient and evaluator, in patients undergoing outpatient primary TKA at Sinai Health.

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 29, 2021
• Study Start: October 1, 2023
• Primary Completion: January 6, 2025
• Study Completion: June 30, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

CA (1)