IPACK Versus Popliteal Sciatic Nerve Block in ACL Reconstruction

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

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.

Study Overview

• Status: Terminated
• Conditions: Anterior Cruciate Ligament Tear
• Intervention / Treatment: Drug: Ropivacaine injection

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FNB-AC + Sciatic nerve block; 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.	Drug: Ropivacaine injection; Total dose not to exceed 3 mg/kg of ropivacaine.
Experimental: FNB-AC + IPACK; 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)	Drug: Ropivacaine injection; Total dose not to exceed 3 mg/kg of ropivacaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intra-operative and up to 48 hours post-discharge, an average of 48 hours

Collaborators and Investigators

• Sponsor: Sujana Dontukurthy

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2019
• Primary Completion (Actual): November 7, 2019
• Study Completion (Actual): November 7, 2019

Study Registration Dates

• First Submitted: June 10, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: STUDY00000281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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