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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05080348
• Other study ID #: iPACK ACL Hamstring Autograft
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2021
• Est. completion date: May 2022

Study information

• Verified date: October 2021
• Source: University of California, San Diego
• Contact: Brenton Alexander, MD
• Phone: (858) 657-7000
• Email: bsalexander[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ACL Injury
• Anesthesia, Local
• Anterior Cruciate Ligament Injuries
• Opioid Use
• Pain, Postoperative

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brenton Alexander

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Post Anesthesia Recovery Unit (PACU) Pain Score	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)	From arrival in PACU until patient has been cleared for PACU discharge
Primary	Total Perioperative Opioid Use (Morphine equivalents)	Intraoperative and Post Operative (in the PACU) opioid use	From time of the start of surgery until time that patient meets PACU discharge criteria
Secondary	PACU Length of Stay (days)	Length of stay from PACU arrival to "ready for discharge" criteria are met	From PACU arrival until criteria for PACU discharge are met
Secondary	PACU Opioid Use (Morphine equivalents)	All opioid use in the PACU	From PACU arrival until criteria for PACU discharge are met
Secondary	Postoperative Day (POD) 1 Opioid Use (Morphine Equivalents)	All Opioid use in the approximate 24 hours following PACU Discharge	Time of discharge from PACU until 24 hours after PACU discharge
Secondary	Best, Worst, Average Pain Scores on POD 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)	For the entire length of post operative day 1