NCT06784882

Brief Summary

This is a single-center pilot study to determine if an adductor canal continuous nerve block is superior to single injection nerve block following total knee arthroplasty. Investigators will randomize participants to either continuous nerve block or single injection nerve block for the adductor canal preoperatively. They will assess differences in pain (measured in numeric rating scale), opioid consumption, and physical therapy milestones from postoperative day 0 to 7.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

January 11, 2025

Last Update Submit

June 12, 2025

Conditions

Keywords

regional anesthesiatotal knee arthroplastynerve block

Outcome Measures

Primary Outcomes (2)

  • analgesic effect of 5-day continuous nerve block of the adductor canal relative to a single inection nerve block with ropivacaine.

    Numeric Rating Scale (NRS) for pain will be superior daily with continuous adductor canal blocks on postoperative days 1-7 following total ankle arthroplasty as compared with single-injection adductor canal blocks (as measured by the "average" daily NRS within the Brief Pain Inventory)

    7 days

  • opioid consumption of 5-day continuous nerve block of the adductor canal relative to a single inection nerve block with ropivacaine.

    Opioid consumption will be superior daily with continuous adductor canal blocks on postoperative days 1-7 following total ankle arthroplasty as compared with single-injection adductor canal blocks (measured in oxycodone equivalents)

    7 days

Secondary Outcomes (4)

  • physical and emotional functioning of 5-day continuous nerve blocks relative to a single injection nerve blocks with ropivacaine

    7 days

  • improvement in physical therapy milestones of 5-day continuous nerve blocks relative to a single injection nerve blocks with ropivacaine

    30 days

  • 30-day pain score measured in Numeric Rating Scale

    30 days

  • 30-day postoperative opioid consumption

    30 days

Study Arms (2)

Continuous adductor canal block

EXPERIMENTAL

single injection with ropivacaine (0.5%) of the adductor canal block and a 5-day continuous perineural infusion of ropivacaine (0.2%) (experimental group)

Device: continuous peripheral nerve block with OnQ pump

single injection adductor canal block

ACTIVE COMPARATOR

single injection with ropivacaine (0.5%) of the adductor canal block and no continuous nerve block added

Drug: single injection nerve block

Interventions

For continuous nerve blocks, the infusion pump that will be used are OnQ pumps (Avanos, Alpharetta, GA) and pre-filled with ropivacaine 0.2% and provided by UCSD's Investigational Drug Services.

Continuous adductor canal block

An adductor canal single injection nerve block will be performed per standard of care. The adductor canal will be identified by ultrasound in the short-axis view. The distal aspect of the femoral triangle (and beginning of the adductor canal) will be identified distal to the mid-thigh in the ipsilateral limb. Using ultrasound guidance, a standard Tuohy block needle will be advanced through a skin wheal of lidocaine until its tip is in the hypoechoic area immediately distal saphenous nerve adjacent to the femoral artery. Twenty milliliters of ropivacaine 0.5% will be injected in divided doses with repeated negative aspiration.

single injection adductor canal block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult participants of at least 18 years of age
  • Undergoing a primary, unilateral, total knee arthroplasty
  • Planned single-injection adductor canal nerve block
  • Weight \> 50 kg (to minimize the risk of local anesthetic toxicity)

You may not qualify if:

  • chronic opioid or tramadol use: daily oxycodone equivalents \> 20 mg for \> 4 weeks
  • neuro-muscular deficit of the surgical limb
  • moderate pain (NRS \> 3) in an anatomic location other than the surgical site
  • planned hospital admission following surgery
  • history of opioid misuse
  • those who lack capacity to complete informed consent
  • inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access)
  • incarceration
  • pregnancy
  • allergy to amide local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

La Jolla, California, 92037, United States

RECRUITING

Related Publications (1)

  • Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

    PMID: 26827847BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Rodney A Gabriel, MD

CONTACT

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
Associate Professor

Study Record Dates

First Submitted

January 11, 2025

First Posted

January 20, 2025

Study Start

June 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

June 17, 2025

Record last verified: 2025-06

Locations