Back to resultsIPACK Versus Popliteal Sciatic Nerve Block in ACL Reconstruction
Primary Purpose
Anterior Cruciate Ligament Tear
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine injection
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Tear
Eligibility Criteria
Inclusion Criteria:
- Patients less than 21 years of age
- American Society of Anesthesiologists physical status I and II
- Undergoing elective anterior cruciate ligament reconstruction
Exclusion Criteria:
- They are unable or unwilling to take part in the study
- History of allergy to any of the medications administered for the nerve block
- Contraindication to peripheral nerve block
- Patients who are unable to understand instructions or questions related to the study or the families required language interpretation
- Patients who consume opioid medications for more than three days per week for more than a month prior to surgery
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
FNB-AC + Sciatic nerve block
FNB-AC + IPACK
Arm Description
Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for sciatic nerve block under ultrasound guidance.
Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for posterior knee capsular infiltration under ultrasound guidance (IPACK)
Outcomes
Primary Outcome Measures
Average Post-operative Pain Score
Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) from arrival to post-anesthesia care unit (PACU) to 48 hours after discharge from surgery center.
Secondary Outcome Measures
Number of Opioid Doses Administered
Number of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03983941
Brief Title
IPACK Versus Popliteal Sciatic Nerve Block in ACL Reconstruction
Official Title
Comparison of Postoperative Analgesic Efficacy of Adductor Canal Block With IPACK Versus Adductor Canal and Popliteal Sciatic Nerve Block in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
PI leaving the institution, no subjects enrolled since 2019, and no other PI interested in taking it over.
Study Start Date
August 30, 2019 (Actual)
Primary Completion Date
November 7, 2019 (Actual)
Study Completion Date
November 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sujana Dontukurthy
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective study comparing femoral nerve block plus sciatic nerve block to femoral nerve block plus infiltration of the posterior knee capsule (IPACK) in patients undergoing arthroscopic anterior cruciate ligament reconstruction. Femoral nerve block via the adductor canal (FNB-AC) with IPACK may provide effective analgesia while avoiding the motor block involved with sciatic nerve block. The lack of motor block is important to facilitate postoperative ambulation and physical therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Tear
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FNB-AC + Sciatic nerve block
Arm Type
Active Comparator
Arm Description
Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for sciatic nerve block under ultrasound guidance.
Arm Title
FNB-AC + IPACK
Arm Type
Experimental
Arm Description
Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for posterior knee capsular infiltration under ultrasound guidance (IPACK)
Intervention Type
Drug
Intervention Name(s)
Ropivacaine injection
Intervention Description
Total dose not to exceed 3 mg/kg of ropivacaine.
Primary Outcome Measure Information:
Title
Average Post-operative Pain Score
Description
Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) from arrival to post-anesthesia care unit (PACU) to 48 hours after discharge from surgery center.
Time Frame
Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours
Secondary Outcome Measure Information:
Title
Number of Opioid Doses Administered
Description
Number of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center.
Time Frame
Intra-operative and up to 48 hours post-discharge, an average of 48 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients less than 21 years of age
American Society of Anesthesiologists physical status I and II
Undergoing elective anterior cruciate ligament reconstruction
Exclusion Criteria:
They are unable or unwilling to take part in the study
History of allergy to any of the medications administered for the nerve block
Contraindication to peripheral nerve block
Patients who are unable to understand instructions or questions related to the study or the families required language interpretation
Patients who consume opioid medications for more than three days per week for more than a month prior to surgery
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
IPACK Versus Popliteal Sciatic Nerve Block in ACL Reconstruction
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