Clinical trial NCT05972018: Liposomal Bupivacaine/Bupivacaine in RS Blocks vs. Ropivacaine in RS Blocks And Catheters
Official title: Liposomal Bupivacaine/Bupivacaine A Single-Dose Bilateral Rectus Sheath Blocks Vs. Ropivacaine in Bilateral RS Blocks And Catheters, Comparing Pain Scores And Opioid Use Following Open Abdominal Vascular Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Aortic Aneurysm, Abdominal
Abdominal Aortic Occlusion
Aortoiliac Occlusive Disease
Aortic Diseases
Keywords: Open abdominal aortic repair surgery
Rectus Sheath Block
Rectus Sheath Block and Catheter
Liposomal Bupivacaine
Exparel
Ropivacaine continuous infusion
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, single-center, open-label, interventional randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this randomized clinical trial is to compare single shot rectus sheath blocks of liposomal bupivacaine/bupivacaine mixture to bilateral rectus sheath catheters infused with ropivacaine (standard of care at our facility) in patients undergoing vascular surgery with an open mid-abdominal laparotomy incision. This study will examine the difference in the highest, lowest, average, and current pain scores reported at the end of 24-48 postoperative hours using the brief pain inventory-short form (BPI-SF).

Participants will be randomized to either receive a single dose of liposomal bupivacaine/bupivacaine mixture intraoperatively at the end of surgery through bilateral rectus sheath blocks (LB/B group) or to receive the standard of care ropivacaine intraoperatively at the end of surgery through bilateral rectus sheath blocks with the insertion of bilateral RS catheter for continuous ropivacaine infusion plus repeated daily boluses (Catheter group; standard care). They will be assessed for a difference in postoperative pain scores, opioid consumption, hospital and PACU length of stay, patient's satisfaction, and quality of recovery. Additionally, we will examine the resources consumed by each intervention, including the medication cost (ropivacaine vs. LB/bupivacaine mixture), block and catheter supply, hospital length of stay, and anesthesia billing time.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18-80 years
2. Patients scheduled for elective vascular surgery with an open mid-abdominal laparotomy incision, including abdominal aortic aneurysm repair surgery (AAA), mesenteric artery bypass surgery, and aortobifemoral bypass surgery for aortic occlusive disease.
3. Patients who are able to speak and read English
4. Patients with American Society of Anesthesiology (ASA) physical status score I-IV
5. Patients who are admitted to the hospital and are incidentally discovered to require any of the aforementioned surgeries, being asymptomatic for vascular issues, and having their surgery scheduled no sooner than three days after admission, are also considered eligible.

Exclusion Criteria:

1. Emergency vascular reconstruction surgery., patients admitted to the hospital due to symptoms directly associated with their vascular condition, such as severe abdominal pain or a ruptured aneurysm causing bleeding, will be excluded.
2. Patients with contraindications to RSB, including but not limited to anatomical abnormality, previous surgical intervention that limits or prevents receiving bilateral RSBs, or infection at the injection site.
3. History of allergy to local anesthetics.
4. Weight \< 40 kg, as a combination of 20 mL of Bupivacaine 0.25% with 30 mL of LB is greater than the maximal dose allowed, given concern for local anesthetic toxicity.
5. Patients who take long-acting opioid medication, or on continuous opioid use \> 50 MME per day for at least 30 days within 90 days prior to surgery.
6. Patients who have chronic pain syndrome with a recent preoperative consultation with the chronic pain service. Also, patients with distant metastatic cancers (e.g. bone, lung, brain) confirmed by CT scan.
7. Patients with current substance abuse, or history of substance abuse within 3 months, this includes any illicit drugs (not including marijuana) or excessive alcohol consumption as defined as 4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men.
8. Lack or refusal to sign the study consent.
9. Patients who are unable to receive postoperative ropivacaine intermittent boluses within the first 5 days after surgery due to issues with their catheter (such as dislodgement, migration, or kinking) will be excluded from the final analysis.

Primary outcomes:
measure: The maximum, average, minimum, and current pain scores at the end of the period 24-48 post-op hours
timeFrame: At the end of the 24 - 48 post-op hours
Secondary outcomes:
measure: Other postoperative pain scores.
timeFrame: Up to 168 postoperative hours and at 2 weeks after discharge
measure: The time to extubation
timeFrame: From anesthesia end date and time to the date and time of extubation, assessed up to 168 postoperative hours
measure: Intraop, postop, and total opioid consumption
timeFrame: Up to discharge, assessed as 2 weeks
measure: Hospital and Intensive Care Unit (ICU) length of stay (LOS)
timeFrame: From the date and time of admission to the date and time of discharge, up to 2 weeks.
measure: The occurrence of block-related and catheter-related complications, or local anesthetics-related adverse events up to hospital discharge or up to one week.
timeFrame: From the date of the block until the date of discharge, assessed up to 1 week
measure: Hospital readmission and ED visits
timeFrame: up to 2 weeks after discharge
measure: Postoperative nausea and vomiting
timeFrame: Up to 168 postoperative hours
measure: Quality of Recovery-40 Questionnaire
timeFrame: On postop day 4, postop day 7, and at 2 weeks after the 168 postoperative hours
measure: Sensory function test
timeFrame: Up to the end of the 168 postoperative hour
measure: Antiemetics use
timeFrame: Up to 168 postoperative hour
measure: Patient satisfaction with pain management using CSAT
timeFrame: at the end of 168 postoperative hours and at 2 weeks after the 168 postoperative hours
measure: The cost of care during hospitalization.
timeFrame: From the time of the blocks until the date of discharge, assessed as 2 weeks
measure: The time to the first rescue opioid.
timeFrame: Up to 168 postoperative hour
measure: The time to first postop antiemetics
timeFrame: Up to 168 postoperative hour
measure: Opioid use and refills within 2 weeks after hospital discharge
timeFrame: Up to 2 weeks after discharge
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Kevin Finkel, MD
role: PRINCIPAL_INVESTIGATOR
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