Clinical trial NCT05080348: Effectiveness of iPACK on Postoperative Pain From Hamstring Autograft Following ACL Repair
Official title: Effectiveness of Preoperative iPACK on Postoperative Pain From Hamstring Autograft for ACL Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
ACL Injury
Anesthesia, Local
Opioid Use
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double blind placebo controlled
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Median Post Anesthesia Recovery Unit (PACU) Pain Score
timeFrame: From arrival in PACU until patient has been cleared for PACU discharge
measure: Total Perioperative Opioid Use (Morphine equivalents)
timeFrame: From time of the start of surgery until time that patient meets PACU discharge criteria
Secondary outcomes:
measure: PACU Length of Stay (days)
timeFrame: From PACU arrival until criteria for PACU discharge are met
measure: PACU Opioid Use (Morphine equivalents)
timeFrame: From PACU arrival until criteria for PACU discharge are met
measure: Postoperative Day (POD) 1 Opioid Use (Morphine Equivalents)
timeFrame: Time of discharge from PACU until 24 hours after PACU discharge
measure: Best, Worst, Average Pain Scores on POD 1
timeFrame: For the entire length of post operative day 1
Other outcomes:
Locations:
Study officials:
References: