Continuous Vs Single Shot Block After ACL
Primary Purpose
ACL Injury
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Sponsored by
About this trial
This is an interventional health services research trial for ACL Injury
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Plainview Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Single Shot
Continuous Block
Arm Description
Patients will receive an adductor canal block in the operating room postoperatively as single shot of 20-30cc bupivacaine
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
Outcomes
Primary Outcome Measures
Pain at Rest
Measured by a visual analogue scale (1-10)
Pain at Rest
Measured by a visual analogue scale (1-10)
Pain at Rest
Measured by a visual analogue scale (1-10)
Pain at Rest
Measured by a visual analogue scale (1-10)
Pain at Rest
Measured by a visual analogue scale (1-10)
Pain at Rest
Measured by a visual analogue scale (1-10)
Worst Pain in the past 24 hours
Measured by visual analogue scale 1-10
Worst Pain in the past 24 hours
Measured by visual analogue scale 1-10
Worst Pain in the past 24 hours
Measured by visual analogue scale 1-10
Worst Pain in the past 24 hours
Measured by visual analogue scale 1-10
Worst Pain in the past 24 hours
Measured by visual analogue scale 1-10
Worst Pain in the past 24 hours
Measured by visual analogue scale 1-10
Secondary Outcome Measures
Daily Opioid Consumption
This will be measured as daily consumption of oxycodone (morphine equivalents)
Incidence of Disturbed Sleep
Measured this by asking if they had a disturbance in their sleep or trouble getting to sleep because of pain in the surgical knee
IKDC - International Knee Documentation Commitee Form for Knee Function
Subjective validated scoring form for knee function. Scale 0-10. 0 for not being able to perform any function. 10 being no limitation in function
Rand Short Form - 36
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate.
The eight sections are:
vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04101682
Brief Title
Continuous Vs Single Shot Block After ACL
Official Title
Continuous Vs Single Shot Adductor Canal Block After ACL Reconstruction - A Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Not enough enrollment
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
May 17, 2022 (Actual)
Study Completion Date
May 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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
Detailed Description
Screening evaluation will occur during the preoperative visit prior to surgery which generally occurs within 28 days prior to surgery. No separate screening is indicated in this study.
Patients will be asked to participate in the study if they are having ACL Reconstruction surgery with one of the orthopedic surgeons who is participating in the study. They will be informed and consented in the office or in the preoperative holding area prior to surgery.
Patients undergo ACL reconstruction at either Plainview, Franklin, Huntington, Long Island Jewish, or North Shore University Hospital.
Any medical condition that is present at the time that the participant is screened will be considered as baseline and not reported as an adverse event (AE). However, if the study participant's condition deteriorates at any time during the study, it will be recorded as an AE.
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event at each level of severity to be performed. AEs characterized as intermittent require documentation of onset and duration of each episode.
The investigator who is making phone calls to the given participant will record all reportable events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. At each study visit/phone call, the investigator will inquire about the occurrence of AE/SAEs since the last visit/phone call. Events will be followed for outcome information until resolution or stabilization.
Study procedures and evaluations
All patients who are enrolled in this study will have been evaluated and determined to be a candidate for ACL reconstruction surgery. The indications for surgery, determination of need for surgery and physical examination determining this need are independent from the interventions and outcomes being assessed by this study.
Efficacy Assessment plan- All patients will be called on postoperative days 1,2,3,4, 7 via and be assessed in person at the post-operative visit. They will be surveyed for primary and secondary outcomes by a study investigator. Primary outcome will be assessed using visual analog scale 0-10. Secondary outcomes; Opiate consumption will be assessed documented during the phone call, Sleep will be assessed by either yes or no answer if the patient had a disturbance in their sleep or had trouble getting to sleep based on pain of the surgical knee in the past 24 hours.
Screening evaluation will occur during the preoperative visit prior to surgery which generally occurs within 28 days prior to surgery. No separate screening is indicated in this study.
Procedure for administering study intervention and follow-up procedures. The participant will be seen in the preoperative holding suite prior to surgery to ensure that patient is still willing to undergo randomization for the study. The patient will then undergo randomization by a computer-based software and the anesthesiologist will be informed of the plan. The participant will undergo anesthesia at the discretion of the anesthesiologist per routine given the participant's clinical baseline. The participant will undergo ACL reconstruction based on the standard of care treatment. Following surgery but prior to leaving the operating room the anesthesiologist will place the adductor canal block and the catheter based on the participant's randomization under ultrasound guidance to ensure proper placement of the block. The participant will then undergo routine post-operative care in the recovery suite with routine recovery room vital checks. For participants who are randomized to the continuous pump group, the pump will be assembled and filled by pharmacy and attached to the previously placed catheter while the participant is in the recovery room. Once the participants are awake and alert in the recovery room, a study investigator will review the study specifics again, including the phone calls with written information on the questions that will be asked. They will also be given written instructions on how to use the continuous pumps and how to remove it. If the patient is uncomfortable removing it themselves, they can come to the office to have it removed. For participants who received a continuous pump the investigator will go over the function of the pump, troubleshooting, and how to remove the pump at home. All participants will be discharged home from the recovery room after they have met the routine discharge criteria following existing standard of care recovery room protocols.
All data will be recorded in an encrypted database which is HIPPA and IRB compliant. All participant information will be labeled with a participant study identification number with no identifiable information documented.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Shot
Arm Type
Active Comparator
Arm Description
Patients will receive an adductor canal block in the operating room postoperatively as single shot of 20-30cc bupivacaine
Arm Title
Continuous Block
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain at Rest
Description
Measured by a visual analogue scale (1-10)
Time Frame
Day 1
Title
Pain at Rest
Description
Measured by a visual analogue scale (1-10)
Time Frame
Day 2
Title
Pain at Rest
Description
Measured by a visual analogue scale (1-10)
Time Frame
Day 3
Title
Pain at Rest
Description
Measured by a visual analogue scale (1-10)
Time Frame
Day 4
Title
Pain at Rest
Description
Measured by a visual analogue scale (1-10)
Time Frame
Day 7
Title
Pain at Rest
Description
Measured by a visual analogue scale (1-10)
Time Frame
Day 14
Title
Worst Pain in the past 24 hours
Description
Measured by visual analogue scale 1-10
Time Frame
Day 1
Title
Worst Pain in the past 24 hours
Description
Measured by visual analogue scale 1-10
Time Frame
Day 2
Title
Worst Pain in the past 24 hours
Description
Measured by visual analogue scale 1-10
Time Frame
Day 3
Title
Worst Pain in the past 24 hours
Description
Measured by visual analogue scale 1-10
Time Frame
Day 4
Title
Worst Pain in the past 24 hours
Description
Measured by visual analogue scale 1-10
Time Frame
Day 7
Title
Worst Pain in the past 24 hours
Description
Measured by visual analogue scale 1-10
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Daily Opioid Consumption
Description
This will be measured as daily consumption of oxycodone (morphine equivalents)
Time Frame
on post operative day 1,2,3,4,7, and 14
Title
Incidence of Disturbed Sleep
Description
Measured this by asking if they had a disturbance in their sleep or trouble getting to sleep because of pain in the surgical knee
Time Frame
on post operative day 1,2,3,4,7, and day 14
Title
IKDC - International Knee Documentation Commitee Form for Knee Function
Description
Subjective validated scoring form for knee function. Scale 0-10. 0 for not being able to perform any function. 10 being no limitation in function
Time Frame
Preoperatively, 3 months, 6 months
Title
Rand Short Form - 36
Description
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate.
The eight sections are:
vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health
Time Frame
Preoperatively, 3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randy Cohn, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Plainview Hospital
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Continuous Vs Single Shot Block After ACL
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