IPACK Versus Popliteal Sciatic Nerve Block in ACL Reconstruction

Anterior Cruciate Ligament Tear Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03983941
• Other study ID #: STUDY00000281
• Status: Terminated
• Phase: Phase 3
• Start date: August 30, 2019
• Est. completion date: November 7, 2019

Study information

• Verified date: August 2021
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: November 7, 2019
• Est. primary completion date: November 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Tear

Intervention

Drug:
• Ropivacaine injection
Total dose not to exceed 3 mg/kg of ropivacaine.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Sujana Dontukurthy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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