Analgesic Value of Adductor Canal vs Femoral Block After Total Knee Arthroplasty

NCT03395990 | Completed Results DMC

• 1 other identifier: PRO00067430
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

An observational study of the effect of femoral nerve block in addition to an adductor canal block for pain following total knee arthroplasty.

Conditions

Osteo Arthritis Knee

Keywords

femoral nerve block; adductor canal block; analgesia

Outcome Measures

Primary Outcomes (1)

• Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain.

  Pain intensity prior to intervention and at 5 minute intervals after intervention. The 11-point Numeric Rating Scale quantifies a subject's pain experience from 0/10 (no pain) to 10/10 (worst pain imaginable).

  Baseline, up to 30 minutes.

Study Arms (2)

chloroprocaine

ACTIVE COMPARATOR

15 ml of 2% chloroprocaine via a femoral nerve block technique

Procedure: Active comparator: chloroprocaine

saline

SHAM COMPARATOR

15 ml of 0.9% saline via a femoral nerve block technique

Procedure: Sham comparator: saline

Interventions

Active comparator: chloroprocaine PROCEDURE

15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.

Also known as: femoral nerve block with chloroprocaine

chloroprocaine

Sham comparator: saline PROCEDURE

15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.

Also known as: femoral nerve block with normal saline

saline

Eligibility Criteria

• Age: 56 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective total knee arthroplasty
• ASA Physical Status I-III
• BMI 18-40 kg/m2

You may not qualify if:

• Inability to cooperate with protocol
• Inability to understand or speak English
• Allergy to any local anesthetic
• Chronic opioid consumption/abuse (30 or more morphine mg equivalents/day)
• Contraindication to adductor canal or femoral nerve block

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

chloroprocaine; 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)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Jeff Gadsden
• Organization: Duke University Medical Center

jeff.gadsden@duke.edu

919-681-6437

Study Officials

• Jeff Gadsden, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Group allocation by sealed envelope; unblinded investigator prepared syringes of study drug (chloroprocaine vs. saline), which look identical to blinded investigator and assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, blinded observational study

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 10, 2018
• Study Start: March 27, 2016
• Primary Completion: October 19, 2016
• Study Completion: October 19, 2016
• Last Updated: June 17, 2020
• Results First Posted: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)