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

Sponsor

Brenton Alexander (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05080348

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative ACL Injury Anesthesia, Local Opioid Use	Procedure: Ropivacaine iPACK Injection Procedure: Normal Saline iPACK Injection	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized double blind placebo controlledRandomized double blind placebo controlled

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Effectiveness of Preoperative iPACK on Postoperative Pain From Hamstring Autograft for ACL Repair

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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).	Procedure: 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
Sham Comparator: 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).	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

Arm

Intervention/Treatment

Active Comparator: 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).

Procedure: 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

Sham Comparator: 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).

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

Outcome Measures

Primary Outcome Measures

Median Post Anesthesia Recovery Unit (PACU) Pain Score [From arrival in PACU until patient has been cleared for PACU discharge]
Median pain score collected in the PACU following surgery on a scale of 1-10 (1 being no pain, 10 being the worst pain the patient has ever experienced)
Total Perioperative Opioid Use (Morphine equivalents) [From time of the start of surgery until time that patient meets PACU discharge criteria]
Intraoperative and Post Operative (in the PACU) opioid use

Secondary Outcome Measures

PACU Length of Stay (days) [From PACU arrival until criteria for PACU discharge are met]
Length of stay from PACU arrival to "ready for discharge" criteria are met
PACU Opioid Use (Morphine equivalents) [From PACU arrival until criteria for PACU discharge are met]
All opioid use in the PACU
Postoperative Day (POD) 1 Opioid Use (Morphine Equivalents) [Time of discharge from PACU until 24 hours after PACU discharge]
All Opioid use in the approximate 24 hours following PACU Discharge
Best, Worst, Average Pain Scores on POD 1 [For the entire length of post operative day 1]
Best, Worst and Average pain scores collected on POD 1 following surgery on a scale of 1-10 (1 being no pain, 10 being the worst pain the patient has ever experienced)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Brenton Alexander

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Brenton Alexander, Associate Physician, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT05080348

Other Study ID Numbers:

iPACK ACL Hamstring Autograft

First Posted:

Oct 15, 2021

Last Update Posted:

Oct 15, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Anterior Cruciate Ligament Injuries

Ropivacaine

Study Results

No Results Posted as of Oct 15, 2021