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Analgesia Technique for ACL Injury

Q: What medical treatments are often supplemented with Adductor Canal Block & IPACK (ACB/IPACK)?

<p>The Adductor Canal Block &#x26; IPACK (ACB/IPACK) is commonly used to tackle ophthalmia and sympathetic conditions. Moreover, it can be employed for the treatment of branch retinal vein occlusion, macular edema, communicable diseases.</p>

Q: Has the Adductor Canal Block & IPACK (ACB/IPACK) received regulatory clearance from the FDA?

<p>The safety of the Adductor Canal Block &#x26; IPACK (ACB/IPACK) has been deemed a 3, since Phase 4 trials have determined it to be an approved medical treatment.</p>

Phase 4

Waitlist Available

Led By Jonathan Beathe, MD

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 13 or greater

Patients undergoing BTB ACL reconstruction with participating surgeon

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from 3 hours post-block administration on post-operative day (pod) 0 until met discharge criteria, assessed up to 1 day

Awards & highlights

Study Summary

This trial found that the addition of local anesthetic infiltration to an adductor canal block (ACB) did not improve postoperative pain control or functional outcomes in patients undergoing bone-tendon-bone (BTB) anterior cruciate ligament (ACL) reconstruction.

Who is the study for?

This trial is for individuals aged 13 or older who are undergoing bone-tendon-bone ACL reconstruction and can follow the study protocol. Participants must speak English, plan to use regional anesthesia, and not have liver or kidney issues, allergies to study meds, diabetes, severe systemic disease (ASA IV), chronic opioid/gabapentin/pregabalin use, a BMI over 40, or be non-English speaking.Check my eligibility

What is being tested?

The trial compares two anesthetic techniques in patients having ACL surgery: Adductor Canal Block (ACB) alone versus ACB with additional infiltration between the popliteal artery and knee capsule (ACB/IPACK). It aims to determine which method provides better pain control during recovery.See study design

What are the potential side effects?

Potential side effects may include discomfort at injection sites, possible nerve damage from needle placement under ultrasound guidance, allergic reactions to Bupivacaine or Dexamethasone used in blocks, and typical risks associated with anesthesia such as nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 13 years old or older.

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I am having BTB ACL surgery with a surgeon in the study.

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I will be receiving regional anesthesia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from 3 hours post-block administration on post-operative day (pod) 0 until met discharge criteria, assessed up to 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from 3 hours post-block administration on post-operative day (pod) 0 until met discharge criteria, assessed up to 1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and from 3 hours post-block administration on post-operative day (pod) 0 until met discharge criteria, assessed up to 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain While at Rest

Secondary outcome measures

Discharge Criteria

Pain With Ambulation

Trial Design

2Treatment groups

Active Control

Group I: Adductor Canal Block (ACB)Active Control3 Interventions

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.

Group II: Adductor Canal Block & IPACK (ACB/IPACK)Active Control3 Interventions

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor

243 Previous Clinical Trials

59,286 Total Patients Enrolled

2 Trials studying Anterior Cruciate Ligament Injury

58 Patients Enrolled for Anterior Cruciate Ligament Injury

Jonathan Beathe, MDPrincipal InvestigatorHospital for Special Surgery, New York

Media Library

Anterior Cruciate Ligament Injury Clinical Trial 2023: Adductor Canal Block (ACB) Highlights & Side Effects. Trial Name: NCT03292926 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility for this research project extend to seniors?

"This research is open to participants aged 13 and over, with the upper age limit set at 80 years old."

Answered by AI

What outcomes is this clinical trial trying to accomplish?

"The purpose of this 24 hour evaluation period is to measure Pain While at Rest. Secondary objectives include ascertaining the patient's NRS Pain score with ambulation and stairs, determining Time to meet discharge criteria using a modified post anesthetic scoring system, and assessing their NRS Pain score while moving around. The ideal result would be attained by achieving the lowest possible numerical value on the 0-10 scale."

Answered by AI

How many participants are included in this research endeavor?

"This research project is not open to recruitment at this time. It was initially posted on October 4th 2017 and has been recently amended August 26th 2022. However, there are presently 100 clinical trials that have vacancies for participants with anterior cruciate ligament tear and 654 medical studies admitting patients who need Adductor Canal Block & IPACK (ACB/IPACK)."

Answered by AI

Are there current openings in this experiment for participants?

"Based on the information from clinicaltrials.gov, this trial is not currently soliciting participants; it was originally posted in October of 2017 and last updated in August 2022. However, there are presently 754 other trials seeking patients for evaluation."

Answered by AI

To whom does this clinical trial offer participation?

"This clinical study is looking for 78 patients who meet the age criteria (13 and older) and have been diagnosed with a tear in their anterior cruciate ligament. Moreover, they must be undergoing BTB ACL reconstruction surgery with one of our participating surgeons."

Answered by AI

What medical treatments are often supplemented with Adductor Canal Block & IPACK (ACB/IPACK)?

"The Adductor Canal Block & IPACK (ACB/IPACK) is commonly used to tackle ophthalmia and sympathetic conditions. Moreover, it can be employed for the treatment of branch retinal vein occlusion, macular edema, communicable diseases."

Answered by AI

Has the Adductor Canal Block & IPACK (ACB/IPACK) received regulatory clearance from the FDA?

"The safety of the Adductor Canal Block & IPACK (ACB/IPACK) has been deemed a 3, since Phase 4 trials have determined it to be an approved medical treatment."

Answered by AI

Could you elucidate what prior research has been conducted regarding the Adductor Canal Block & IPACK (ACB/IPACK) combination?

"At present, 654 medical experiments investigating Adductor Canal Block & IPACK (ACB/IPACK) are up and running. Of these active trials, 160 have reached Phase 3 status. Primarily located in Mishawaka, Indiana, there is a total of 18 788 sites hosting clinical tests for this particular intervention."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Novel Analgesia Technique for ACL Reconstruction

2017. "A Novel Analgesia Technique for ACL Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03292926.

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