Evaluation of Exparel Adductor Canal Field Block for Pain Control After ACL Reconstruction

NCT04764916 | Unknown Phase 3 FDA Drug

• 1 other identifier: 19-574
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized study for adult patients presenting to the Carilion Clinic Institute of Orthopedics and Neurosurgery. Patients undergoing isolated ACL reconstruction will be eligible for inclusion. All patients will receive an adductor canal block (either with bupivacaine or Exparel. Patients will be given a pain diary for self-report of pill counts, pain scores, block duration, and pain control satisfaction). Pill counts and pain scores will also be taken by a team member at two and six-week post-operative visits. Primary outcomes include opioid requirements and pain scores.

Conditions

Anterior Cruciate Ligament Tear; Pain, Postoperative; Opioid Use

Outcome Measures

Primary Outcomes (2)

• Total opioid consumption

  Total amount of opioids taken by each patient

  2 weeks post-operatively

• Total opioid consumption

  Total amount of opioids taken by each patient

  6 weeks post-operatively

Secondary Outcomes (3)

• Pain control quantified by numerical rating scale

  2 weeks post-operatively

• Pain control quantified by intervention-based pain scale

  2 weeks post-operatively

• Block length

  Self reported anytime from immediately post-op until 2 weeks post-operatively. Likely 1-3 days

Study Arms (2)

Exparel/Intervention group

EXPERIMENTAL

Will receive 10mL of standard 0.5% bupivacaine followed by 10mL of liposomal bupivacaine as adductor canal field block preoperatively

Drug: Liposomal bupivacaine; Drug: Bupivacaine Hydrochloride

Standard of Care group

ACTIVE COMPARATOR

Will receive 20mL of standard 0.5% bupivacaine as adductor canal field block preoperatively

Drug: Bupivacaine Hydrochloride

Interventions

Liposomal bupivacaine DRUG

Liposomal bupivacaine will be used as adductor canal block

Exparel/Intervention group

Bupivacaine Hydrochloride DRUG

This is the facility's standard of care medication for this procedure

Exparel/Intervention group; Standard of Care group

Eligibility Criteria

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

You may qualify if:

• years old
• Presenting to Carilion Clinic Institute of Orthopedics and Neuroscience
• Receiving an isolated, first-time ACL reconstruction
• Operation to be performed at the Roanoke Ambulatory Surgery Center

You may not qualify if:

• Prior opioid use within 30 days of operation
• Under 18 or over 65 years old
• Use of opioids for chronic pain management
• Patients with multi-ligament injuries
• Patients who are receiving a revision of a previously reconstructed ACL
• Patients with an allergy to the study drug(s)
• Patients not medically eligible for surgery
• Women who are pregnant

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Clinic Institute for Orthopaedics and Neurosciences

Roanoke, Virginia, 24014, United States

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Thomas K Miller, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas K Miller, MD

CONTACT

540-512-1082; TKMiller@carilionclinic.org

Brandon Temel, BS

CONTACT

6209602272; btemel@carilionclinic.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Surgeons and patients will be blinded to study arm until 2 week post-operative visit. Anesthesiology and their staff will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One study group receives standard bupivacaine. One group receives liposomal bupivacaine (Exparel). All other study procedures are identical

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 21, 2021
• Study Start: February 16, 2021
• Primary Completion: February 16, 2022
• Study Completion: March 2, 2022
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)