Continuous Vs Single Shot Block After ACL

NCT04101682 | Terminated Early Phase 1 DMC FDA Drug

• 1 other identifier: 18-0811
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will be randomizing patients to either receive an adductor canal block in the operating room postoperatively as single shot of 20-30cc bupivacaine or to have a catheter inserted into the adductor canal which will be attached up to a continuous infusion pump of bupivacaine that will have a set flow rate over the next couple days. The investigators' hypothesis is that patients will have better pain control, sleep, and decreased opioid consumption with the use of a continuous infusion pump

Conditions

ACL Injury

Outcome Measures

Primary Outcomes (12)

• Pain at Rest

  Measured by a visual analogue scale (1-10)

  Day 1

• Pain at Rest

  Measured by a visual analogue scale (1-10)

  Day 2

• Pain at Rest

  Measured by a visual analogue scale (1-10)

  Day 3

• Pain at Rest

  Measured by a visual analogue scale (1-10)

  Day 4

• Pain at Rest

  Measured by a visual analogue scale (1-10)

  Day 7

• Pain at Rest

  Measured by a visual analogue scale (1-10)

  Day 14

• Worst Pain in the past 24 hours

  Measured by visual analogue scale 1-10

  Day 1

• Worst Pain in the past 24 hours

  Measured by visual analogue scale 1-10

  Day 2

• Worst Pain in the past 24 hours

  Measured by visual analogue scale 1-10

  Day 3

• Worst Pain in the past 24 hours

  Measured by visual analogue scale 1-10

  Day 4

• Worst Pain in the past 24 hours

  Measured by visual analogue scale 1-10

  Day 7

• Worst Pain in the past 24 hours

  Measured by visual analogue scale 1-10

  Day 14

Secondary Outcomes (4)

• Daily Opioid Consumption

  on post operative day 1,2,3,4,7, and 14

• Incidence of Disturbed Sleep

  on post operative day 1,2,3,4,7, and day 14

• IKDC - International Knee Documentation Commitee Form for Knee Function

  Preoperatively, 3 months, 6 months

• Rand Short Form - 36

  Preoperatively, 3 months, 6 months

Study Arms (2)

Single Shot

ACTIVE COMPARATOR

Patients will receive an adductor canal block in the operating room postoperatively as single shot of 20-30cc bupivacaine

Drug: Bupivacaine

Continuous Block

ACTIVE COMPARATOR

Patients will have a catheter inserted into the adductor canal which will be attached up to a continuous infusion pump of bupivacaine that will have a set flow rate over the next couple days

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

Administered by an anesthesiologist or certified nurse anesthetist, under ultrasound guidance a catheter placed overlying the nerve sheath. This catheter is then connected to a device with a reservoir that administers local anesthetic at a set rate.

Continuous Block; Single Shot

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged \>16 years old
• In good general health as evidenced by medical history and deemed medically healthy enough to tolerate surgery by the patient's primary care physician
• MRI with evidence of ACL tear, and wanting to have an ACL reconstruction surgery
• Ability to take oral medication and be willing to adhere to the study intervention, including telephone calls
• Agrees to complete surveys required on the days specified between 5-9PM

You may not qualify if:

• Current daily opioid requirement exceeding the equivalent of 15mg morphine
• Daily prescription of corticosteroid, tricyclic antidepressant, gabapentin, or tramadol
• Carrying the diagnosis of chronic pain syndrome, uncontrolled anxiety, history of schizophrenia or related psychiatric disorders
• History of alcohol or drug abuse/addiction
• History of preexisting nerve damage in the surgical extremity
• Knee surgery (same knee) in the previous 12 weeks
• Anticipated knee surgery in the other knee planned in the ensuing 6 months
• Diabetic patients with blood sugar values exceeding 250 mg/dl in the previous month
• BMI \>40Kg/m2
• Pregnancy, which will be determined by a serum or urine HCG test on the day of surgery.
• Incarceration
• Inability to communicate with staff, including being unreachable by telephone
• Revision ACL reconstruction
• Patient reconsideration after initial agreement.
• Non-English speaking subjects

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Plainview Hospital

Plainview, New York, 11803, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Randy Cohn, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: September 24, 2019
• Study Start: September 25, 2020
• Primary Completion: May 17, 2022
• Study Completion: May 17, 2022
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)