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Effectiveness of iPACK on Postoperative Pain From Hamstring Autograft Following ACL Repair

NCT ID: NCT05080348

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2022-05-31

Brief Summary

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Patients undergoing ACL repair with hamstring autograft frequently develop significant post operative pain at the hamstring grafting site. This pain is within the distribution of a commonly used regional nerve block, the Interspace between the popliteal artery and capsule of the knee (iPACK). The investigators plan to randomize consenting patients to either receiving a SHAM injection of normal saline or to an interventional group of long acting local anesthetic (Ropivacaine) injected in the popliteal fossa between the popliteal artery and capsule of the knee (iPACK). Both groups of patients will receive standard of care with respect to perioperative pain management, which includes a preoperative adductor canal nerve block and preoperative acetaminophen administration. Dual primary endpoints of postoperative pain scores and mean postoperative opioid use will be retrieved and compared between groups. Additional secondary endpoints will be PACU length of stay, PACU opioid use, POD1 opioids use, and POD1 pain scores (best, worst, average).

Detailed Description

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Conditions

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Pain, Postoperative ACL Injury Anesthesia, Local Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized double blind placebo controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
The patient will not know which group they are in as they will be injected with either SHAM or Intervention group, which the pharmacy will create. As a result, the anesthesiologist performing the injection and the intraoperative anesthesiologist will also not know if the patient received a SHAM or intervention injection. This will also apply to the PACU nurse. The person performing the data analysis will know which patients received the intervention, as this is required for data analysis.

Study Groups

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Ropivacaine iPACK

Patient will receive standard of care for perioperative pain management. In addition, they will receive a single preoperative injection of 20cc of 0.25% Ropivacaine with 1:400,000 epinephrine in the Interspace between the Popliteal Artery and Capsule of the Knee (iPACK).

Group Type ACTIVE_COMPARATOR

Ropivacaine iPACK Injection

Intervention Type PROCEDURE

Injection of 20mL of 0.25% Ropivacaine with 1:400,000 Epinephrine between in the Interspace between the Popliteal Artery and the Capsule of the Knee (iPACK) using ultrasound guidance at the level of the femoral condyles

Normal Saline iPACK

Patient will receive standard of care for perioperative pain management. In addition, they will receive a single preoperative injection of 20cc of 0.9% Normal Saline in the Interspace between the Popliteal Artery and Capsule of the Knee (iPACK).

Group Type SHAM_COMPARATOR

Normal Saline iPACK Injection

Intervention Type PROCEDURE

Injection of 20mL of 0.9% Normal Saline between in the Interspace between the Popliteal Artery and the Capsule of the Knee (iPACK) using ultrasound guidance at the level of the femoral condyles

Interventions

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Ropivacaine iPACK Injection

Injection of 20mL of 0.25% Ropivacaine with 1:400,000 Epinephrine between in the Interspace between the Popliteal Artery and the Capsule of the Knee (iPACK) using ultrasound guidance at the level of the femoral condyles

Intervention Type PROCEDURE

Normal Saline iPACK Injection

Injection of 20mL of 0.9% Normal Saline between in the Interspace between the Popliteal Artery and the Capsule of the Knee (iPACK) using ultrasound guidance at the level of the femoral condyles

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Undergoing ACL surgery with expected Hamstring Autograft by Dr. Catherine Robertson at UC San Diego
* At least 18 years of age
* Able to Provide Consent in English prior to Surgery

Exclusion Criteria

* Pregnancy (a urine pregnancy test is standard at UCSD for female patients prior to menopause who are sexually active with the opposite sex within the previous year)
* Inability to communicate with the investigators and hospital staff
* Severe renal, hepatic or cardiac disease
* Chronic high-dose opioid use (defined as daily use for more than 4 weeks prior to surgery of at least the equivalent of 20 mg oxycodone)
* BMI \> 45 kg/m2
* Allergy to study medications (lidocaine, bupivacaine)
* Incarceration.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brenton Alexander

OTHER

Sponsor Role lead

Responsible Party

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Brenton Alexander

Associate Physician

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Brenton Alexander, MD

Role: CONTACT

[email protected]
(858) 657-7000

Rodney Gabriel, MD, MAS

Role: CONTACT

[email protected]
(858) 657-7000

Other Identifiers

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iPACK ACL Hamstring Autograft

Identifier Type: -

Identifier Source: org_study_id