Back to resultsA Novel Analgesia Technique for ACL Reconstruction
Primary Purpose
Anterior Cruciate Ligament Injury
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Ultrasound
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Injury
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing BTB ACL reconstruction with participating surgeon
- Age 13 or greater
- Planned use of regional anesthesia
- Ability to follow study protocol
- English speaking (secondary outcomes include questionnaires validated in English only)
Exclusion Criteria:
- Hepatic or renal insufficiency
- Younger than 13 years old
- Patients undergoing general anesthesia
- Allergy or intolerance to one of the study medications
- BMI > 40
- Diabetes
- American Society of Anesthesiology (ASA) score IV
- Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- Chronic opioid use (taking opioids for longer than 3 months, or daily morphine equivalent of >5mg/day for one month)
- Non-English speaking
Sites / Locations
- Hospital for Special Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Adductor Canal Block (ACB)
Adductor Canal Block & IPACK (ACB/IPACK)
Arm Description
The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation. The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.
Outcomes
Primary Outcome Measures
Pain While at Rest
Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10.
Secondary Outcome Measures
Discharge Criteria
Time to meet discharge criteria utilizing the modified post anesthetic discharge scoring system. The frame represents when the measurements began, i.e. 3 hours after the administration of the anesthetic block. This represents time zero, at which recording would then begin.
Pain With Ambulation
NRS Pain score with ambulation & stairs. A lower score is a better outcome. Score range is from 0 to 10.
Full Information
NCT ID
NCT03292926
First Posted
September 20, 2017
Last Updated
August 28, 2023
Sponsor
Hospital for Special Surgery, New York
1. Study Identification
Unique Protocol Identification Number
NCT03292926
Brief Title
A Novel Analgesia Technique for ACL Reconstruction
Official Title
A Randomized Controlled Trial to Evaluate a Novel Analgesia Technique for ACL Reconstruction: Adductor Canal Block With an IPACK Versus Adductor Canal Block
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 4, 2017 (Actual)
Primary Completion Date
March 16, 2021 (Actual)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
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.
No
5. Study Description
Brief Summary
A comparison of two anesthetic techniques-- the Adductor Canal Block (ACB) and the Adductor Canal Block with Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (ACB/IPACK)-- in patients undergoing bone-tendon-bone (BTB) anterior cruciate ligament (ACL) reconstruction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adductor Canal Block (ACB)
Arm Type
Active Comparator
Arm Description
The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
Arm Title
Adductor Canal Block & IPACK (ACB/IPACK)
Arm Type
Active Comparator
Arm Description
The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Bupivacaine will help treat pain and sensation after ACL repair
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound will guide anesthesiologist in performing the different nerve blocks
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
preservative free Dexamethasone
Intervention Description
Dexamethasone will be used to prolong block duration
Primary Outcome Measure Information:
Title
Pain While at Rest
Description
Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10.
Time Frame
24 hours post-block administration
Secondary Outcome Measure Information:
Title
Discharge Criteria
Description
Time to meet discharge criteria utilizing the modified post anesthetic discharge scoring system. The frame represents when the measurements began, i.e. 3 hours after the administration of the anesthetic block. This represents time zero, at which recording would then begin.
Time Frame
From 3 hours post-block administration on Post-operative day (POD) 0 until met discharge criteria, assessed up to 1 day
Title
Pain With Ambulation
Description
NRS Pain score with ambulation & stairs. A lower score is a better outcome. Score range is from 0 to 10.
Time Frame
3 hours post-block administration on Post-operative day (POD) 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing BTB ACL reconstruction with participating surgeon
Age 13 or greater
Planned use of regional anesthesia
Ability to follow study protocol
English speaking (secondary outcomes include questionnaires validated in English only)
Exclusion Criteria:
Hepatic or renal insufficiency
Younger than 13 years old
Patients undergoing general anesthesia
Allergy or intolerance to one of the study medications
BMI > 40
Diabetes
American Society of Anesthesiology (ASA) score IV
Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
Chronic opioid use (taking opioids for longer than 3 months, or daily morphine equivalent of >5mg/day for one month)
Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Beathe, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Novel Analgesia Technique for ACL Reconstruction
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