IPACK Versus Popliteal Sciatic Nerve Block in ACL Reconstruction

NCT03983941 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: STUDY00000281
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Opioid Doses Administered

  Intra-operative and up to 48 hours post-discharge, an average of 48 hours

Study Arms (2)

FNB-AC + Sciatic nerve block

ACTIVE COMPARATOR

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

FNB-AC + IPACK

EXPERIMENTAL

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

Interventions

Ropivacaine injection DRUG

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

FNB-AC + IPACK; FNB-AC + Sciatic nerve block

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients less than 21 years of age
• American Society of Anesthesiologists physical status I and II
• Undergoing elective anterior cruciate ligament reconstruction

You may not qualify if:

• 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

Sponsors & Collaborators

• Sujana Dontukurthy: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Julie Rice-Weimer, RN
• Organization: Nationwide Children's Hospital

julie.rice-weimer@nationwidechildren.org

614-355-3142

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 12, 2019
• Study Start: August 30, 2019
• Primary Completion: November 7, 2019
• Study Completion: November 7, 2019
• Last Updated: September 16, 2021
• Results First Posted: September 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)