IPACK Versus Popliteal Sciatic Nerve Block in ACL Reconstruction

NCT ID: NCT03983941

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-30
• Study Completion Date: 2019-11-07

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.

Conditions

Anterior Cruciate Ligament Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ropivacaine injection

Intervention Type: DRUG

Total dose not to exceed 3 mg/kg of ropivacaine.

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)

Group Type: EXPERIMENTAL

Ropivacaine injection

Intervention Type: DRUG

Total dose not to exceed 3 mg/kg of ropivacaine.

Interventions

Ropivacaine injection

Total dose not to exceed 3 mg/kg of ropivacaine.

Intervention Type: DRUG

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

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sujana Dontukurthy

OTHER

Sponsor Role: lead

Responsible Party

Sujana Dontukurthy

Clinical Assistant Professor of Anesthesiology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00000281

Identifier Type: -

Identifier Source: org_study_id