iPACK for Post-op Pain Following ACL Reconstruction

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-25

Study Completion Date

2023-08-14

Brief Summary

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This study will consist of patients 12 years and older undergoing ACL reconstruction using a quadriceps or bone-patella tendon bone (BTB) graft. The patients will be randomized to adductor canal block alone, or adductor canal block + iPACK block. The primary goal will be to determine the differences in postoperative pain during the first 72 hours when comparing the two groups. Secondary outcomes will include opioid utilization during the first 72 hours postoperatively and range of motion including terminal knee extension at postoperative follow-up visits.

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Detailed Description

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Conditions

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ACL Injury Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Only the patient will be blinded to the treatment group.

Study Groups

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Adductor Canal Block (ACB) Only

Participants randomized to the ACB only group will receive an adductor canal block alone.

Group Type ACTIVE_COMPARATOR

Adductor Canal Block (ACB) Only

Intervention Type DRUG

Patients will receive an ACB with lidocaine skin wheal

ACB + iPACK

Participants randomized to the ACB + iPACK group will receive both the ACB and iPACK block.

Group Type ACTIVE_COMPARATOR

Adductor Canal Block (ACB) + iPACK Block

Intervention Type DRUG

Patients will receive an ACB with iPACK block

Interventions

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Adductor Canal Block (ACB) Only

Patients will receive an ACB with lidocaine skin wheal

Intervention Type DRUG

Adductor Canal Block (ACB) + iPACK Block

Patients will receive an ACB with iPACK block

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 12 years and older
* Patients who are scheduled to undergo an ACL reconstruction with quadriceps or BTB graft.

Exclusion Criteria

* Any contraindication to receiving regional anesthesia. This may include infection at the site of injection, allergy to local anesthetic, or pre-existing nerve injury.
* Patients undergoing hamstring graft or allograft for ACL
* Pre-existing infection at the site of injury
* Patients on chronic opioid treatments
* Pre-existing sensory or motor deficit in operative extremity
* Patients having a revision of previous ACL reconstruction
* Pregnant and/or lactating women
* Weighs less than 40kg

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No