Liposomal Bupivacaine/Bupivacaine in RS Blocks vs. Ropivacaine in RS Blocks And Catheters

Launched by HARTFORD HOSPITAL · Jul 25, 2023

Keywords

ClinConnect Summary

This clinical trial is looking to compare two different pain management methods for patients undergoing vascular surgery with a large abdominal incision. One group of participants will receive a single injection of a pain-relieving medication called liposomal bupivacaine/bupivacaine at the end of their surgery, while the other group will receive a continuous infusion of another pain medication called ropivacaine through a catheter that is placed during surgery. The main goal is to see how these two methods affect pain levels and comfort in the days following the surgery, as well as to evaluate the use of hospital resources and patient satisfaction.

To be eligible for this trial, participants should be between 18 and 80 years old and scheduled for certain types of elective vascular surgeries, like repairing an abdominal aortic aneurysm. They need to be able to read and speak English and meet specific health criteria. Throughout the study, participants will be monitored for their pain levels, the amount of pain medication they use, their recovery experience, and how long they stay in the hospital or recovery area. This trial is currently recruiting participants, and understanding the differences between these pain management options could help improve patient care in the future.

Gender

ALL

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.