Liposomal Bupivacaine/Bupivacaine in Rectus Sheath Blocks Versus Ropivacaine in Rectus Sheath Blocks And Catheters

Phase 4RecruitingNCT05972018

Hartford Hospital14 enrolled

Overview

The goal of this pilot study 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 assess the safety and feasibility of this approach compared to standard of care. Participants will receive either a single dose of liposomal bupivacaine/bupivacaine mixture intraoperatively at the end of surgery through bilateral rectus sheath blocks (LB/B group) or 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 differences in the rate of postoperative complications, resources consumed with each intervention, as well as postoperative pain scores, opioid consumption, hospital and PACU length of stay, patient's satisfaction, and quality of recovery, and hospital length of stay.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Aortic Aneurysm, Abdominal Abdominal Aortic Occlusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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. 10. Patients with a plan to undergo abdominal wall surgery, in addition to the vascular surgery that involves a mid-abdomen incision, such as abdominal wall reconstruction surgery. The additional abdominal wall incisions or interventions might have an impact on the study's pain, opioid, and LOS outcomes.

Outcomes

Primary Outcomes

The cost of care during hospitalization.

To compare the resources consumed by each intervention from many different perspectives (e.g. anesthesia staff cost per time spent to perform the study intervention and the successive daily evaluations, facility cost per length of stay, block and catheter medication cost, block and catheter supply cost.)

Time frame: From the time of the blocks until the date of discharge, assessed as 2 weeks

The occurrence of block-related and catheter-related complications, or local anesthetics-related adverse events up to hospital discharge or up to one week.

Determine whether patients receiving ropivacaine in rectus sheath catheter versus Bupivacaine/Liposomal Bupivacaine in rectus sheath block have any difference in the occurrence of any related complications or adverse events up to hospital discharge or up to one week.

Time frame: From the date of the block until the date of discharge, assessed up to 1 week

Postoperative nausea and vomiting

Compare the occurrence of postoperative nausea and vomiting using the Simplified Postoperative Nausea and Vomiting Impact Scale which consists of two questions, with a possible response total score of 0-6. Response score totals of 0-2 require no intervention. Response score totals of 3-4 may necessitate antiemetic medication. Response score totals of 5-6 are considered clinically important nausea requiring medication intervention, as this would constitute patients with excessive vomiting. This scale will be used daily through the duration of in-hospital care (1-7 days)

Time frame: Up to 96 postoperative hours

Secondary Outcomes

Postoperative pain scores.

The maximum, average, minimum, and current pain scores for the past 24 hours, on a scale from 0-10 where 0 is no pain and 10 is severe pain reported by participants, daily and up to the end of the 96 postoperative hours and at 2 weeks after discharge using the validated tool; Brief Pain Inventory-Short Form.

Time frame: Intensive Care Unit time duration and up to 96 postoperative hours

The time to extubation

The time to extubation: from anesthesia end time to the time of removing the endotracheal tube in the Intensive Care Unit.

Time frame: From anesthesia end date and time to the date and time of extubation, assessed up to 96 postoperative hours

Intraop, postop, and total opioid consumption

The intraoperative, postoperative, and total opioid consumption during hospitalization using morphine milliequivalent doses (MME) between the groups.

Time frame: During hospitalization up to 7 post-operative days

Hospital and Intensive Care Unit (ICU) length of stay (LOS)

Determine whether patients receiving ropivacaine in RSC versus B/LB in RSB have any the difference in the duration of ICU stay, in addition to the duration of hospitalization if \> or \< 7 days.

Time frame: From the date and time of admission to the date and time of discharge, up to 2 weeks.

Hospital readmission and ED visits

Incidences of hospital readmission and emergency visits within 2 weeks after discharge

Time frame: up to 2 weeks after discharge

Quality of Recovery-40 Questionnaire

Determine any differences between the two groups in the quality of recovery using the "Quality of Recovery Questionnaire-40 questionnaire" which consists of 40 questions categorized into 5 dimensions; emotional state (9 questions), physical comfort (12 questions), psychological support (7 questions), physical independence (5 questions), and pain (7 questions). All questions scored from 1-5; positive items are scored from 1 (worst) to 5 (best); whereas scores are reversed for negative items 1 (best) to 5 (worst).

Time frame: On postop day 4, at 2 weeks after discharge

Patient satisfaction with pain management using CSAT

Patient satisfaction with pain management after surgery using the CSAT score: 5 very satisfied, 4 satisfied, 3 neutral, 2 unsatisfied, 1 very unsatisfied. this assessment on the day of discharge (estimated 168 postoperative hours) and at 2 weeks after discharge, via a phone call.

Time frame: At discharge and at 2 weeks after the discharge, up to 96 postoperative hours

The time to the first rescue opioid.

The time from the last intraoperative opioid given to the time of the first rescue opioid given after surgery is measured in hours.

Time frame: Up to 96 postoperative hour

The time to first postop antiemetics

The time from the last intraoperative antiemetic medication given to the time of the first rescue antiemetic medication given after surgery is measured in hours.

Time frame: Up to 96 postoperative hour

Opioid use and refills within 2 weeks after hospital discharge

Opioid use and refills within 2 weeks after hospital discharge (yes or no)

Time frame: Up to 2 weeks after discharge