Pain Control After Total Knee Arthroplasty: Benefit In Adding Single Shot Adductor Canal Block to Existing Pain Regimen Protocol?

NCT02740192 | Completed Early Phase 1

• 1 other identifier: 10221
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double blinded, standard of care controlled clinical trial. All adult patients over eighteen desiring total knee arthroplasty will be eligible. The study compares pain control, opioid consumption, and physical exam findings in patients undergoing total knee arthroplasty between patients receiving adductor canal block and those who receiving periarticular injection alone.

Conditions

Pain

Outcome Measures

Primary Outcomes (4)

• Post-operative pain level (Visual Analog Scale)

  Patients' pain levels will be recorded every 6 hours using VAS (Visual Analog Scale) by the nursing staff from when the patient arrives on the inpatient floor to when the patient is discharged from the hospital.

  Through study completion, an average of 3 days

• Knee flexion and extension Range of Motion (ROM)

  Patients' knee ROM will be assessed every morning at 6:30am by the rounding physician on the inpatient floor until the patient is discharged from the hospital.

  Through study completion, an average of 3 days

• Distance Walked (meters)

  Patients will work with Physical Therapists 2 times day (AM and PM). Distance walked (meters) will be recorded by the Physical Therapist from postoperative day #1 until the patient is discharged from the hospital.

  Through study completion, an average of 3 days

• Pain with Ambulation (VAS)

  Patients will work with Physical Therapists 2 times day (AM and PM). Pain with ambulation (VAS) will be recorded by the Physical Therapist from postoperative day #1 until the patient is discharged from the hospital.

  Through study completion, an average of 3 days

Secondary Outcomes (2)

• Pain Medication Intake

  Through study completion, an average of 3 days

• Time to discharge readiness

  Through study completion, an average of 3 days

Study Arms (2)

Adductor Canal Block

EXPERIMENTAL

Patients in this group received local infiltration of bupivacaine in the adductor canal after surgery, in addition to the periarticular injection intra-op.

Procedure: Adductor Canal Block; Procedure: Periarticular Injection; Drug: Ropivacaine; Drug: Bupivacaine

Periarticular Injection

SHAM COMPARATOR

Patients in this group received a bandaid at the presumed adductor canal injection site, in addition to the periarticular injection intra-op.

Procedure: Periarticular Injection; Drug: Ropivacaine

Interventions

Adductor Canal Block PROCEDURE

Post-op adductor canal block using Bupivacaine

Adductor Canal Block

Periarticular Injection PROCEDURE

Intra-op periarticular injection of Ropivacaine

Adductor Canal Block; Periarticular Injection

Ropivacaine DRUG

Ropivacaine was used for the periarticular injection

Also known as: Naropin

Adductor Canal Block; Periarticular Injection

Bupivacaine DRUG

Bupivacaine was used for the periarticular injection

Also known as: Marcaine

Adductor Canal Block

Eligibility Criteria

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

You may not qualify if:

• Patients will be excluded if their medical history presents chronic opioid use (greater than 3 month use),
• pregnancy,
• history of intolerance to medications in the study, and substantial substance abuse.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Ropivacaine; Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Surgeon

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: April 15, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 30, 2023

Record last verified: 2023-10

Locations

US (1)