ACL Injury, Anesthesia, Local, Opioid Use, Pain, Postoperative
Conditions
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).
Interventions
PROCEDURERopivacaine 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
PROCEDURENormal 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
Sponsors
Brenton Alexander
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
Intervention model description
Randomized double blind placebo controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Contacts
Primary ContactBrenton Alexander, MD
Backup ContactRodney Gabriel, MD, MAS
Outcome results
None listed