Continuous Adductor Canal Block in Fast Track Total Knee Arthroplasty

NCT05962970 | Unknown

• 1 other identifier: 21-0041-A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee arthroplasty (TKA) is a frequent performed surgery. Many institutions are implementing fast track 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 ambulatory TKA, and its effects on patients' quality of recovery. Investigators hypothesize that continuous adductor canal block would lead to decrease in opioid consumption in patients undergoing fast track TKA. Significance There are no published prospective randomized controlled trials to assess patient's reported quality of recovery after receiving CACB in same day primary knee arthroplasties. As this is a frequent type of surgery and has the prediction to increase its incidence for the next years, there is significant importance in investigations about interventions which may improve its recovery in a fast track regime. A postoperative analgesic technique that offers better pain control, has less adverse effects, reduces the opioid analgesia requirement and is safe to be used in a fast track setting may have additional impact on decreasing health care cost and may lead to an enhanced recovery and better quality of life. Objectives To evaluate effectiveness and safety of using CACB in patients undergoing ambulatory TKA, in comparison to SACB. Primary objective is opioid consumption (in oral morphine equivalent doses) Secondary objectives are to evaluate postoperative QoR-15 scores (10), pain scores, opioid-induced adverse effects (measured via validated opioid symptom distress scale), postoperative functional status, complications relating to the perineural catheter and readmissions.

Conditions

Total Knee Arthroplasty

Keywords

Orthopaedic; Postoperative Pain Management; total knee arthroplasty; Continuous adductor canal block; Fast-track

Outcome Measures

Primary Outcomes (1)

• opioid consumption

  opioid consumption. Total opioid consumption changes will be assessed at 24, 48, 72 hours, seven, 30 and 90 days postoperatively.

  At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively

Secondary Outcomes (3)

• Quality of Recovery

  At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively

• Intensity of postoperative pain

  At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively

• Opioid related side effects

  At baseline, 24, 48, 72 hours, seven, 30 and 90 days postoperatively

Study Arms (2)

CACB

ACTIVE COMPARATOR

continuous adductor canal block

Drug: continuous adductor canal block (CACB) ropivacaine

Control group

PLACEBO COMPARATOR

sham continuous adductor canal block - ShACB

Drug: sham continuous adductor canal block - ShACB NaCl

Interventions

continuous adductor canal block (CACB) ropivacaine DRUG

The CACB group will receive an infusion of 0.2% ropivacaine 5mL/h

CACB

sham continuous adductor canal block - ShACB NaCl DRUG

sham continuous adductor canal block - ShACB and ShACB group will receive an infusion of NaCl 0.9% 5mL/h.

Control group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing unilateral primary TKA in the fast track setting.
• Patients older than 21 years of age, with 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:

• Perioperative complication or discharge delay leading to hospital admission.
• 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

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital, Toronto

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

Related Publications (12)

• 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

• Wang J, Vahid S, Eberg M, Milroy S, Milkovich J, Wright FC, Hunter A, Kalladeen R, Zanchetta C, Wijeysundera HC, Irish J. Clearing the surgical backlog caused by COVID-19 in Ontario: a time series modelling study. CMAJ. 2020 Nov 2;192(44):E1347-E1356. doi: 10.1503/cmaj.201521. Epub 2020 Sep 1.

  PMID: 32873541 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

• Khan MI, Khandadashpoor S, Rai Y, Vertolli G, Backstein D, Siddiqui N. Comparing Analgesia on an As-Needed Basis to Traditional Intravenous Patient-Controlled Analgesia Within Fast-Track Orthopedic Procedures: A Randomized Controlled Trial. Pain Manag Nurs. 2022 Dec;23(6):832-837. doi: 10.1016/j.pmn.2022.04.003. Epub 2022 May 20.

  PMID: 35599141 BACKGROUND

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Naveed Siddiqui, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naveed Siddiqui, MD

CONTACT

416-586-4800; naveed.siddiqui@uhn.ca

Yehoshua Gleicher, MD

CONTACT

416-586-4800; Josh.Gleicher@sinaihealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: July 27, 2023
• Study Start: October 4, 2023
• Primary Completion: August 3, 2024
• Study Completion: December 31, 2024
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)