A Novel Analgesia Technique for ACL Reconstruction

Anterior Cruciate Ligament Injury Clinical Trial

Official title:

A Randomized Controlled Trial to Evaluate a Novel Analgesia Technique for ACL Reconstruction: Adductor Canal Block With an IPACK Versus Adductor Canal Block

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03292926
• Other study ID #: 2017-0934
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 4, 2017
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A comparison of two anesthetic techniques-- the Adductor Canal Block (ACB) and the Adductor Canal Block with Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (ACB/IPACK)-- in patients undergoing bone-tendon-bone (BTB) anterior cruciate ligament (ACL) reconstruction.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 78
• Est. completion date: June 2024
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergoing BTB ACL reconstruction with participating surgeon

• Age 13 or greater

• Planned use of regional anesthesia

• Ability to follow study protocol

• English speaking (secondary outcomes include questionnaires validated in English only)

Exclusion Criteria:

• Hepatic or renal insufficiency

• Younger than 13 years old

• Patients undergoing general anesthesia

• Allergy or intolerance to one of the study medications

• BMI > 40

• Diabetes

• American Society of Anesthesiology (ASA) score IV

• Chronic gabapentin/pregabalin use (regular use for longer than 3 months)

• Chronic opioid use (taking opioids for longer than 3 months, or daily morphine equivalent of >5mg/day for one month)

• Non-English speaking

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Injury

Intervention

Drug:
• Bupivacaine
Bupivacaine will help treat pain and sensation after ACL repair

Device:
• Ultrasound
Ultrasound will guide anesthesiologist in performing the different nerve blocks

Drug:
• Dexamethasone
Dexamethasone will be used to prolong block duration

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain While at Rest	Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10.	24 hours post-block administration
Secondary	Discharge Criteria	Time to meet discharge criteria utilizing the modified post anesthetic discharge scoring system. The frame represents when the measurements began, i.e. 3 hours after the administration of the anesthetic block. This represents time zero, at which recording would then begin.	From 3 hours post-block administration on Post-operative day (POD) 0 until met discharge criteria, assessed up to 1 day
Secondary	Pain With Ambulation	NRS Pain score with ambulation & stairs. A lower score is a better outcome. Score range is from 0 to 10.	3 hours post-block administration on Post-operative day (POD) 0