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Pain ManagementNCT02276495

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

A study testing ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block and Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline in people with Pain Management, run by University of California, Irvine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain Management
What is being tested?
ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block and Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
1 Jan 2015to 30 Sep 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • Opioid tolerant patients (defined as greater than 30 mg Morphine equivalent consumed daily)
  • Patients that are diabetic with peripheral neuropathy
  • BMI greater than 40

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, Irvine Medical Center

    Orange, California, 92868

Other trials in United States

About this study

Official title: Does Single Injection Adductor Canal Block Improve Postoperative Analgesia in Patients Receiving Periarticular Local Anesthesia Injections for Total Knee Arthroplasty?

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).

Read the detailed description

Total knee arthroplasty (TKA), also known as total knee replacement, has been associated with a significant pain burden in the postoperative period. Methods to manage pain associated with this operation have in the past included injecting pain medication into the epidural space of the spinal cord, around a peripheral nerve, around the space surrounding the joint, or a combination of pain management techniques.

In recent years, the femoral nerve block (injection of pain medication around the peripheral nerve, specifically the femoral nerve) has been proposed as an effective way to manage pain while sparing many of the undesirable side effects of narcotic pain medications. Traditional techniques of the femoral nerve block involve the injection of pain medication around the peripheral nerve at the level of the groin area. A nerve block at this point in the path of the femoral nerve affects all of the musculature of the front part of the thigh as well as the nerves responsible for sensation to the majority of the knee joint. The femoral nerve block performed at the level of the groin provides an excellent level of pain relief at the knee joint, but is also associated with weakness of the quadriceps muscle. The resultant quadriceps weakness can both slow the physical therapy process and be a risk factor for post-operative falls. Participation in physical therapy is a critical component of the rehabilitation process and is started as soon as tolerated by the patient. The ideal pain management technique would provide the same degree of pain relief as the femoral nerve block while preserving the strength in the front part of the thigh muscles.

One suggested technique to achieve both of these goals is the injection of a large volume dilute local pain medication mixture around the joint during surgery. This has been used as a substitute to provide pain relief around the joint while maintaining strength in the quadriceps muscle and the ability to participate in physical therapy. This technique however, does not last long since the medication disperses away from the joint space.

A variation of the femoral nerve block in the lower thigh, within a space called the adductor canal, has been demonstrated to provide equivalent amounts of pain relief as a proximal femoral nerve block along with preservation of motor function to the quadriceps muscle. What is not as well-established is whether the combination of injecting pain medication directly around the joint space in the knee along with a single injection of pain medication in the adductor canal in the lower thigh can improve pain scores and extend the duration of pain relief provided compared to only an injection around the joint space.

Conditions
Pain Management
Being tested
ACB Control - 20 ml saline injection for ACB, 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
Keywords
pain management for total knee arthroplasty
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACB Control - 20 ml saline injection for ACBOther

    Adductor Canal Block Control (20 ml saline injection)

  • ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal BlockDrug

    Adductor Canal Block Study (20 ml 0.5% Ropivacaine)

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

    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)

Study groups in NCT02276495
Study groupRoleWhat they receive
ACB Control + Local InfiltrationExperimentalACB Control - 20 ml saline injection for ACB + Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline
Receives: 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 infiltrationExperimentalACB 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
Receives: 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 OnlyExperimentalACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block
Receives: Drug: ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: within 24 hours postoperative

Secondary outcomes (2)
  1. Opioid Use

    24 Hour post-surgical opioid use

    Measured: within 24 hours postoperative

  2. Ambulation Distance

    Total distance ambulated during physical therapy during first 24 hours

    Measured: First 24 hours post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2014 (estimated)
  2. Study start1 Jan 2015
  3. Primary completion20 Jun 2020
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02276495
Sponsor's protocol ID
20141217
Other IDs
UCIANES06
Status last verified
Oct 2024
First submitted
20 Oct 2014
Last updated
29 Oct 2024
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21388906
  • 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.

    PubMed 23891055
  • 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.

    PubMed 16698416
  • 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.

    PubMed 19606021
  • 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.

    PubMed 20966667
  • 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.

    PubMed 19553071
  • 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.

    PubMed 24121608
  • 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.

    PubMed 23897505
  • 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.

    PubMed 22325963
  • 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.

    PubMed 23783531

Questions about this trial

What is this clinical trial studying?

A study testing ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block and Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline in people with Pain Management, run by University of California, Irvine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Score (time frame: within 24 hours postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02276495, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.

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