Single Injection Adductor Canal Block vs Catheter for Total Knee Arthroplasty

NCT02798835 | Completed Phase 4 Results

• 1 other identifier: H16-01058
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study investigates single injection adductor canal block (ACB) with or without intravenous dexamethasone and adductor canal catheter for pain management of total knee arthroplasty. This is a non-inferiority trial seeking to determine whether single injection ACB with dexamethasone is "no worse" than a continuous catheter.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Cumulative 24 Hour Oral Morphine Equivalent Consumption

  Post-operative analgesia at 24 hours

  24 hours (Day 1)

Secondary Outcomes (7)

• Cumulative 12 Hour Oral Morphine Equivalent Consumption

  12 hours (Day 0)

• Cumulative 48 Hour Oral Morphine Equivalent Consumption

  48 hours (Day 2)

• Pain Score

  12, 24 and 48 hours

• Quality of Recovery (QoR-40)

  48 hours (Day 2)

• Length of Stay

  From surgical date until hospital discharge, up to 3 weeks

Other Outcomes (2)

• Adductor Canal Block Complications

  From time of catheter insertion until catheter removal, up to Day2/48 hours

• Nerve Block Complications

  0 to 48 hours

Study Arms (3)

Adductor Canal block

ACTIVE COMPARATOR

Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.

Drug: Adductor canal block; Drug: Bupivacaine; Drug: Fentanyl; Drug: Ropivacaine 0.5% Injectable Solution

Adductor canal block with dexamethasone

ACTIVE COMPARATOR

Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.

Drug: Adductor canal block with dexamethasone; Drug: Bupivacaine; Drug: Fentanyl; Drug: Ropivacaine 0.5% Injectable Solution; Drug: Dexamethasone

Adductor canal catheter

ACTIVE COMPARATOR

Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.

Drug: Adductor canal catheter; Drug: Bupivacaine; Drug: Fentanyl; Drug: Ropivacaine 0.5% Injectable Solution

Interventions

Adductor canal block DRUG

Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.

Adductor Canal block

Adductor canal block with dexamethasone DRUG

Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.

Adductor canal block with dexamethasone

Adductor canal catheter DRUG

Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.

Adductor canal catheter

Bupivacaine DRUG

Used in spinal anesthetic

Adductor Canal block; Adductor canal block with dexamethasone; Adductor canal catheter

Fentanyl DRUG

May or may not be used in spinal anesthetic

Adductor Canal block; Adductor canal block with dexamethasone; Adductor canal catheter

Ropivacaine 0.5% Injectable Solution DRUG

Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.

Adductor Canal block; Adductor canal block with dexamethasone; Adductor canal catheter

Dexamethasone DRUG

To be given intravenously at time of nerve block to one of the study arms.

Adductor canal block with dexamethasone

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over or equal to the age of 18 years old who can understand the study protocol and are able to give consent
• Patients with an American Society of Anaesthesiology (ASA) classification 1 to 3
• Patients must have a preoperative oral 24 hour opioid consumption of less than or equal to 30 mg morphine equivalents
• Patients must be able to understand and be able to use patient controlled analgesia
• Patients must be undergoing a primary total knee arthroplasty with neuraxial anesthesia

You may not qualify if:

• Patients with a contraindication to neuraxial and/or regional anaesthesia
• Patients with an allergy to local anaesthetics
• Patients who have chronic pain not related to their knee joint
• Patients with chronic opioid use (daily or almost daily use \>3 months)
• Patients with contraindications to dexamethasone (allergy, infection, Insulin dependent Diabetes Mellitus)
• Patients with pre-existing neuropathy
• Patients with hepatic failure
• Patients with renal failure with eGFR\<60
• Patients with allergy to ketorolac or NSAIDs

Sponsors & Collaborators

• University of British Columbia: lead

Related Publications (9)

• Perlas A, Kirkham KR, Billing R, Tse C, Brull R, Gandhi R, Chan VW. The impact of analgesic modality on early ambulation following total knee arthroplasty. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):334-9. doi: 10.1097/AAP.0b013e318296b6a0.

  PMID: 23759708 BACKGROUND

• Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.

  PMID: 24401769 BACKGROUND

• Allen HW, Liu SS, Ware PD, Nairn CS, Owens BD. Peripheral nerve blocks improve analgesia after total knee replacement surgery. Anesth Analg. 1998 Jul;87(1):93-7. doi: 10.1097/00000539-199807000-00020.

  PMID: 9661553 BACKGROUND

• Charous MT, Madison SJ, Suresh PJ, Sandhu NS, Loland VJ, Mariano ER, Donohue MC, Dutton PH, Ferguson EJ, Ilfeld BM. Continuous femoral nerve blocks: varying local anesthetic delivery method (bolus versus basal) to minimize quadriceps motor block while maintaining sensory block. Anesthesiology. 2011 Oct;115(4):774-81. doi: 10.1097/ALN.0b013e3182124dc6.

  PMID: 21394001 BACKGROUND

• Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.

  PMID: 23241723 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

• Abdallah FW, Johnson J, Chan V, Murgatroyd H, Ghafari M, Ami N, Jin R, Brull R. Intravenous dexamethasone and perineural dexamethasone similarly prolong the duration of analgesia after supraclavicular brachial plexus block: a randomized, triple-arm, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):125-32. doi: 10.1097/AAP.0000000000000210.

  PMID: 25629321 BACKGROUND

• Rahangdale R, Kendall MC, McCarthy RJ, Tureanu L, Doty R Jr, Weingart A, De Oliveira GS Jr. The effects of perineural versus intravenous dexamethasone on sciatic nerve blockade outcomes: a randomized, double-blind, placebo-controlled study. Anesth Analg. 2014 May;118(5):1113-9. doi: 10.1213/ANE.0000000000000137.

  PMID: 24686045 BACKGROUND

• Lee S, Rooban N, Vaghadia H, Sawka AN, Tang R. A Randomized Non-Inferiority Trial of Adductor Canal Block for Analgesia After Total Knee Arthroplasty: Single Injection Versus Catheter Technique. J Arthroplasty. 2018 Apr;33(4):1045-1051. doi: 10.1016/j.arth.2017.11.018. Epub 2017 Nov 16.

  PMID: 29198872 DERIVED

MeSH Terms

Interventions

Dexamethasone; Bupivacaine; Fentanyl; Ropivacaine

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Steven Lee
• Organization: Department of Anesthesia and Perioperative Care, Vancouver General Hospital, Vancouver, BC, Canada.

steven.lee2@vch.ca

6048754111

Study Officials

• Steven Lee, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 14, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 4, 2020
• Results First Posted: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share