Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04764916
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Carilion Clinic

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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Tear Pain, Postoperative Opioid Use Drug: Liposomal bupivacaine Drug: Bupivacaine Hydrochloride Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One study group receives standard bupivacaine. One group receives liposomal bupivacaine (Exparel). All other study procedures are identical
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Surgeons and patients will be blinded to study arm until 2 week post-operative visit. Anesthesiology and their staff will not be blinded.
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Exparel Adductor Canal Field Block for Pain Control After Anterior Cruciate Ligament Reconstruction
Actual Study Start Date : February 16, 2021
Estimated Primary Completion Date : February 16, 2022
Estimated Study Completion Date : March 2, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exparel/Intervention group
Will receive 10mL of standard 0.5% bupivacaine followed by 10mL of liposomal bupivacaine as adductor canal field block preoperatively
Drug: Liposomal bupivacaine
Liposomal bupivacaine will be used as adductor canal block

Drug: Bupivacaine Hydrochloride
This is the facility's standard of care medication for this procedure

Active Comparator: Standard of Care group
Will receive 20mL of standard 0.5% bupivacaine as adductor canal field block preoperatively
Drug: Bupivacaine Hydrochloride
This is the facility's standard of care medication for this procedure




Primary Outcome Measures :
  1. Total opioid consumption [ Time Frame: 2 weeks post-operatively ]
    Total amount of opioids taken by each patient

  2. Total opioid consumption [ Time Frame: 6 weeks post-operatively ]
    Total amount of opioids taken by each patient


Secondary Outcome Measures :
  1. Pain control quantified by numerical rating scale [ Time Frame: 2 weeks post-operatively ]
    Pain control reported by patient uses NRS pain scale. 0-10 with 10 being worst pain.

  2. Pain control quantified by intervention-based pain scale [ Time Frame: 2 weeks post-operatively ]
    Pain control reported by patient using our intervention-based pain scale. 1-6 with 6 being most difficult to control pain.

  3. Block length [ Time Frame: Self reported anytime from immediately post-op until 2 weeks post-operatively. Likely 1-3 days ]
    Duration of adductor canal block, reported by patient



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04764916


Contacts
Layout table for location contacts
Contact: Thomas K Miller, MD 540-512-1082 TKMiller@carilionclinic.org
Contact: Brandon Temel, BS 6209602272 btemel@carilionclinic.org

Locations
Layout table for location information
United States, Virginia
Carilion Clinic Institute for Orthopaedics and Neurosciences Recruiting
Roanoke, Virginia, United States, 24014
Contact: Thomas K Miller, MD    540-512-1082    TKMiller@carilionclinic.org   
Sponsors and Collaborators
Carilion Clinic
Investigators
Layout table for investigator information
Principal Investigator: Thomas K Miller, MD Carilion Clinic
Layout table for additonal information
Responsible Party: Carilion Clinic
ClinicalTrials.gov Identifier: NCT04764916    
Other Study ID Numbers: 19-574
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Anterior Cruciate Ligament Injuries
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Knee Injuries
Leg Injuries
Wounds and Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents