Recruiting
Phase 3

Exparel

Sponsor:

Carilion Clinic

Code:

NCT04764916

Conditions

Anterior Cruciate Ligament Tear

Pain, Postoperative

Opioid Use

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Liposomal bupivacaine

Bupivacaine Hydrochloride

Study Details

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

Study ID

NCT04764916

Start date

Feb 16, 2021

Status verified date

Feb, 2021

Completion date

Mar 2, 2022

Anticipated

Primary completion date

Feb 16, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18-65 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exparel/Intervention group

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

active comparator: Standard of Care group

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

Interventions

Liposomal bupivacaine

Liposomal bupivacaine will be used as adductor canal block

Bupivacaine Hydrochloride

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

Primary outcome measure

  • Total opioid consumption [ Time Frame: 2 weeks post-operatively ]
  • Total opioid consumption [ Time Frame: 6 weeks post-operatively ]

Central Contacts and Locations

Central contacts

Thomas K Miller, MD

540-512-1082TKMiller@carilionclinic.org

Brandon Temel, BS

6209602272btemel@carilionclinic.org

Locations

Carilion Clinic Institute for Orthopaedics and Neurosciences

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Thomas K Miller, MD

540-512-1082TKMiller@carilionclinic.org

More Information

Sponsor

Carilion Clinic

Last update posted

Feb 21, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carilion Clinic on 2021-02-21.