Can Single-Injection Adductor Canal Blocks Improve PostOp Pain Relief in Patients Undergoing Total Knee Arthroplasty?

NCT02276495 | Completed Results DMC

• 2 other identifiers: 20141217UCIANES06
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the effect of a single injection adductor canal block (ACB) on pain scores within 24 hours post total knee arthroplasty (TKA).

Conditions

Pain Management

Keywords

pain management for total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Pain Score

  The primary outcome variable of interest is the median maximum pain score within 24 hours postoperative. Pain scores were rated on a scale from 0 - 10, with 0 being no discomfort/pain and 10 being worst imaginable pain.

  within 24 hours postoperative

Secondary Outcomes (2)

• Opioid Use

  within 24 hours postoperative

• Ambulation Distance

  First 24 hours post-operative

Other Outcomes (3)

• Baseline Anxiety

  pre-operative day of surgery

• Baseline Pain Score

  Preoperatively day of surgery

• NRS Pain Rating

  Preop, PACU, and 4,8, 12, and 24 hours post-operatively.

Study Arms (3)

ACB Control + Local Infiltration

EXPERIMENTAL

ACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline

Other: ACB Control - 20 ml saline injection for ACB; Drug: Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline

ACB Study + Local infiltration

EXPERIMENTAL

ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline

Drug: ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block; Drug: Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline

ACB Study Only

EXPERIMENTAL

ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block

Drug: ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block

Interventions

ACB Control - 20 ml saline injection for ACB OTHER

Adductor Canal Block Control (20 ml saline injection)

ACB Control + Local Infiltration

ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block DRUG

Adductor Canal Block Study (20 ml 0.5% Ropivacaine)

ACB Study + Local infiltration; ACB Study Only

Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline DRUG

100 mLs of a solution containing: Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)

ACB Control + Local Infiltration; ACB Study + Local infiltration

Eligibility Criteria

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

You may qualify if:

• Males and Females age 18+ years old having total knee arthroplasty (TKA) at UCI Medical Center
• American Society of Anesthesiologists physical status I to III

You may not qualify if:

• Allergy to local anesthetics
• Pregnancy
• Nursing Mothers
• Children \<18 years of age
• Renal impairment (GFR\<60 mL/min/1.73m2)
• Hepatic Impairment (active hepatitis, elevated AST or ALT, jaundice)
• Opioid tolerant patients (defined as greater than 30 mg Morphine equivalent consumed daily)
• Patients that are diabetic with peripheral neuropathy
• BMI greater than 40

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Related Publications (10)

• Wylde V, Rooker J, Halliday L, Blom A. Acute postoperative pain at rest after hip and knee arthroplasty: severity, sensory qualities and impact on sleep. Orthop Traumatol Surg Res. 2011 Apr;97(2):139-44. doi: 10.1016/j.otsr.2010.12.003. Epub 2011 Mar 8.

  PMID: 21388906 BACKGROUND

• Robbins SM, Rastogi R, McLaughlin TL. Predicting acute recovery of physical function following total knee joint arthroplasty. J Arthroplasty. 2014 Feb;29(2):299-303. doi: 10.1016/j.arth.2013.06.033. Epub 2013 Jul 26.

  PMID: 23891055 BACKGROUND

• Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.

  PMID: 16698416 BACKGROUND

• Buvanendran A, Kroin JS. Multimodal analgesia for controlling acute postoperative pain. Curr Opin Anaesthesiol. 2009 Oct;22(5):588-93. doi: 10.1097/ACO.0b013e328330373a.

  PMID: 19606021 BACKGROUND

• Paul JE, Arya A, Hurlburt L, Cheng J, Thabane L, Tidy A, Murthy Y. Femoral nerve block improves analgesia outcomes after total knee arthroplasty: a meta-analysis of randomized controlled trials. Anesthesiology. 2010 Nov;113(5):1144-62. doi: 10.1097/ALN.0b013e3181f4b18.

  PMID: 20966667 BACKGROUND

• Feibel RJ, Dervin GF, Kim PR, Beaule PE. Major complications associated with femoral nerve catheters for knee arthroplasty: a word of caution. J Arthroplasty. 2009 Sep;24(6 Suppl):132-7. doi: 10.1016/j.arth.2009.04.008. Epub 2009 Jun 24.

  PMID: 19553071 BACKGROUND

• Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.

  PMID: 24121608 BACKGROUND

• Mudumbai SC, Kim TE, Howard SK, Workman JJ, Giori N, Woolson S, Ganaway T, King R, Mariano ER. Continuous adductor canal blocks are superior to continuous femoral nerve blocks in promoting early ambulation after TKA. Clin Orthop Relat Res. 2014 May;472(5):1377-83. doi: 10.1007/s11999-013-3197-y.

  PMID: 23897505 BACKGROUND

• Ng FY, Ng JK, Chiu KY, Yan CH, Chan CW. Multimodal periarticular injection vs continuous femoral nerve block after total knee arthroplasty: a prospective, crossover, randomized clinical trial. J Arthroplasty. 2012 Jun;27(6):1234-8. doi: 10.1016/j.arth.2011.12.021. Epub 2012 Feb 8.

  PMID: 22325963 BACKGROUND

• Teng Y, Jiang J, Chen S, Zhao L, Cui Z, Khan MS, Du W, Gao X, Wang J, Xia Y. Periarticular multimodal drug injection in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1949-57. doi: 10.1007/s00167-013-2566-0. Epub 2013 Jun 20.

  PMID: 23783531 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Sodium Chloride; Ropivacaine; Epinephrine; Ketorolac; Clonidine; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

The PI changed twice during the study period, and the final PI left after the beginning of the COVID-19 pandemic. We have endeavored to collect as much of the original study data as possible in order to close out this record, but many measures were not collected (baseline anxiety \& pain, NRS scores, etc). We have reported as much as possible based on hospital records and existing data that was collected during the study period.

Results Point of Contact

• Title: Dr. Joseph Rinehart
• Organization: UC Irvine Health Department of Anesthesiology & Perioperative Care

jrinehar@hs.uci.edu

714-456-7415

Study Officials

• Joseph Rinehart, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 28, 2014
• Study Start: January 1, 2015
• Primary Completion: June 20, 2020
• Study Completion: September 30, 2024
• Last Updated: October 29, 2024
• Results First Posted: October 29, 2024

Record last verified: 2024-10

Locations

US (1)