A Novel Analgesia Technique for ACL Reconstruction

NCT03292926 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2017-0934
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anterior Cruciate Ligament Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Discharge Criteria

  From 3 hours post-block administration on Post-operative day (POD) 0 until met discharge criteria, assessed up to 1 day

• Pain With Ambulation

  3 hours post-block administration on Post-operative day (POD) 0

Study Arms (2)

Adductor Canal Block (ACB)

ACTIVE COMPARATOR

The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.

Drug: Bupivacaine; Device: Ultrasound; Drug: Dexamethasone

Adductor Canal Block & IPACK (ACB/IPACK)

ACTIVE COMPARATOR

The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation. The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.

Drug: Bupivacaine; Device: Ultrasound; Drug: Dexamethasone

Interventions

Bupivacaine DRUG

Bupivacaine will help treat pain and sensation after ACL repair

Adductor Canal Block & IPACK (ACB/IPACK); Adductor Canal Block (ACB)

Ultrasound DEVICE

Ultrasound will guide anesthesiologist in performing the different nerve blocks

Adductor Canal Block & IPACK (ACB/IPACK); Adductor Canal Block (ACB)

Dexamethasone DRUG

Dexamethasone will be used to prolong block duration

Also known as: preservative free Dexamethasone

Adductor Canal Block & IPACK (ACB/IPACK); Adductor Canal Block (ACB)

Eligibility Criteria

• Age: 13 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10023, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Bupivacaine; Ultrasonography; Dexamethasone

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Jonathan Beathe
• Organization: Hospital for Special Surgery, Anesthesiology

beatheJ@hss.edu

2126061036

Study Officials

• Jonathan Beathe, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 26, 2017
• Study Start: October 4, 2017
• Primary Completion: March 6, 2020
• Study Completion: April 16, 2020
• Last Updated: September 19, 2024
• Results First Posted: May 12, 2022

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)