Adductor Canal Block (ACB) Before and After Primary Total Knee Arthroplasty (TKA)

NCT02908711 | Completed Phase 4 DMC

• 1 other identifier: 0524-16-RMC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee arthroplasty (TKA) is associated with severe postoperative pain. Multimodal analgesia, including peripheral nerve block, is recommended for post-operative pain relief 1. Perineural analgesia offers the advantage of extended pain relief up to 24 hours after surgery2. This is a prospective, randomized control trial designed to compare the analgesic efficacy of the adductor canal block (ACB) performed immediately before or immediately after primary total knee arthroplasty (TKA). The primary objective of this study is to measure pain score associated with knee motion following TKA among patients receiving ACB as part of their analgesic regimen for TKA. Secondary end points include assessment of postoperative ambulation, range of motion, pain at rest, opioid consumption, and patient satisfaction between the two analgesic approaches. The investigators hypothesize that ACB before the surgery will reduce a patient's postoperative pain and improve patient satisfaction. All consecutive patients undergoing primary TKA will be recruited for enrollment in the study. Patients will be for randomized preoperatively to receive either preemptive ABC (PreACB) or postoperative ABC (PostACB). Patients randomized to the PreACB group will receive the block prior to incision. Patients randomized to the PostACB group will receive the block at the end of the surgery. Both techniques are in accordance to the standard of care at our institute. All patients will have the ACB done by a regional anesthesiologist in the regional anesthesia unit, or in the operating room. Patient medical history will be obtained and blocks will be placed per usual protocol. Operative and anesthetic details, including medications given, will be recorded. Pain scores and pain medications given in the PACU will be recorded. Supplementary analgesics will be provided per institutional PACU protocol. Study data will be recorded for up to 72 hours or until patient discharge. A follow-up will occur in 4- 6 weeks at the orthopedic follow-up appointment to evaluate the patient's late pain scores and overall satisfaction. Data will be analyzed both at the conclusion of the study and at several intervals prior to completion of the study.

Conditions

Anesthesia, Regional

Outcome Measures

Primary Outcomes (1)

• Pain score associated with knee motion following TKA

  This study's primary endpoint the change in the patient's reported pain score on the preoperative visit, on postoperative day (POD) 1, and the patient's pain score reported on the 4-6 week follow- up visit. Pain score will be measured using a numeric verbal analogue scale (1-10). Pain will be measured using this scale on the pre-operative visit, and on POD1 prior to manipulation, with active (patient driven) movement and with passive (physician elicited) movement.

  4-6 Weeks postoperatively

Secondary Outcomes (10)

• Opioid consumption

  4-6 weeks postoperatively

• Patient satisfaction between the two analgesic approaches.

  24 hours postoperatively

• Assessment of postoperative ambulation.

  4-6 weeks postoperatively

• Assessment of postoperative pain at rest

  4-6 weeks postoperatively

• Thrombo-embolic complications

  Up to 24 weeks

Study Arms (2)

Patients receiving ACB before primary TKA

ACTIVE COMPARATOR

Patients receiving adductor canal block (ACB) before primary total knee arthroplasty (TKA). Patients randomized to this group will receive the block prior to incision after induction of general anesthesia

Drug: 0.5% ropivacaine

Patients receiving ACB after primary TKA

ACTIVE COMPARATOR

Patients receiving adductor canal block (ACB) immediately after primary total knee arthroplasty (TKA). Patients randomized to this group will receive the block at the end of the surgery.

Drug: 0.5% ropivacaine

Interventions

0.5% ropivacaine DRUG

Adductor canal block (ACB) performed as part of their analgesic regimen for primary total knee arthroplasty achieved with 20 cc of 0.5% ropivacaine under constant ultrasound visualization.

Patients receiving ACB after primary TKA; Patients receiving ACB before primary TKA

Eligibility Criteria

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

You may not qualify if:

• Allergy to local anesthetics or to systemic opioids
• Contraindication to regional anesthesia technique, such as local infection or coagulopathy
• Sensory/motor disorder involving operative limb
• Requirements of more than 30 mg morphine equivalent daily prior to surgery
• ASA 4 or greater
• Psychiatric or cognitive disorders
• Incarceration
• Renal insufficiency with Cr \> 2.0
• Hepatic failure
• Pregnancy
• Age under 18 years

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petach Tikvah, Israel

Location

Related Publications (11)

• Fischer HB, Simanski CJ, Sharp C, Bonnet F, Camu F, Neugebauer EA, Rawal N, Joshi GP, Schug SA, Kehlet H; PROSPECT Working Group. A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty. Anaesthesia. 2008 Oct;63(10):1105-23. doi: 10.1111/j.1365-2044.2008.05565.x. Epub 2008 Jul 10.

  PMID: 18627367 BACKGROUND

• O'Donnell BD, Iohom G. Regional anesthesia techniques for ambulatory orthopedic surgery. Curr Opin Anaesthesiol. 2008 Dec;21(6):723-8. doi: 10.1097/aco.0b013e328314b665.

  PMID: 19009687 BACKGROUND

• Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.

  PMID: 22221014 BACKGROUND

• Kang H, Ha YC, Kim JY, Woo YC, Lee JS, Jang EC. Effectiveness of multimodal pain management after bipolar hemiarthroplasty for hip fracture: a randomized, controlled study. J Bone Joint Surg Am. 2013 Feb 20;95(4):291-6. doi: 10.2106/JBJS.K.01708.

  PMID: 23302898 BACKGROUND

• Kazak Bengisun Z, Aysu Salviz E, Darcin K, Suer H, Ates Y. Intraarticular levobupivacaine or bupivacaine administration decreases pain scores and provides a better recovery after total knee arthroplasty. J Anesth. 2010 Oct;24(5):694-9. doi: 10.1007/s00540-010-0970-x. Epub 2010 Jun 23.

  PMID: 20571832 BACKGROUND

• Essving P, Axelsson K, Aberg E, Spannar H, Gupta A, Lundin A. Local infiltration analgesia versus intrathecal morphine for postoperative pain management after total knee arthroplasty: a randomized controlled trial. Anesth Analg. 2011 Oct;113(4):926-33. doi: 10.1213/ANE.0b013e3182288deb. Epub 2011 Aug 4.

  PMID: 21821506 BACKGROUND

• Myles PS, Hunt JO, Nightingale CE, Fletcher H, Beh T, Tanil D, Nagy A, Rubinstein A, Ponsford JL. Development and psychometric testing of a quality of recovery score after general anesthesia and surgery in adults. Anesth Analg. 1999 Jan;88(1):83-90. doi: 10.1097/00000539-199901000-00016.

  PMID: 9895071 BACKGROUND

• Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.

  PMID: 10740540 BACKGROUND

• Insall JN, Dorr LD, Scott RD, Scott WN. Rationale of the Knee Society clinical rating system. Clin Orthop Relat Res. 1989 Nov;(248):13-4.

  PMID: 2805470 BACKGROUND

• Melvin JS, Stryker LS, Sierra RJ. Tranexamic Acid in Hip and Knee Arthroplasty. J Am Acad Orthop Surg. 2015 Dec;23(12):732-40. doi: 10.5435/JAAOS-D-14-00223. Epub 2015 Oct 22.

  PMID: 26493971 BACKGROUND

• Heller S, Shemesh S, Rukinglaz O, Cohen N, Velkes S, Fein S. Efficacy of single-shot adductor canal block before Versus after primary total knee arthroplasty - Does timing make a difference? A randomized controlled trial. J Orthop Surg (Hong Kong). 2022 Sep-Dec;30(3):10225536221132050. doi: 10.1177/10225536221132050.

  PMID: 36189733 DERIVED

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2016
• First Posted: September 21, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: September 4, 2018

Record last verified: 2016-08

Locations

IL (1)