IPACK Versus Popliteal Sciatic Nerve Block in ACL Reconstruction

Phase 3

Terminated

• Conditions: Anterior Cruciate Ligament Tear
• Interventions: Drug: Ropivacaine injection

• Registration Number: NCT03983941
• Lead Sponsor: Sujana Dontukurthy

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-11
• Study First Posted: 2019-06-12
• Study Start: 2019-08-30
• Primary Completion: 2019-11-07
• Study Completion: 2019-11-07
• Results First Submitted: 2021-07-27
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-20
• Last Update Submitted: 2021-08-20
• Results First Posted: 2021-09-16
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FNB-AC + Sciatic nerve block	Ropivacaine injection	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.
FNB-AC + IPACK	Ropivacaine injection	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)

Primary Outcome Measures

Name	Time	Method
Average Post-operative Pain Score	Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours	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

Name	Time	Method
Number of Opioid Doses Administered	Intra-operative and up to 48 hours post-discharge, an average of 48 hours	Number of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States