Liposomal Bupivacaine/Bupivacaine in RS Blocks vs. Ropivacaine in RS Blocks And Catheters (EXODUS)

October 19, 2023 updated by: Kevin Finkel, Hartford Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RSB LB/B
Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS) (30mL per side)
Drug: Liposomal bupivacaine
Rectus Sheath Block: Total 60mL: (20mL 1.3% Liposomal bupivacaine + 30mL 0.25% bupivacaine + 10mL NS).(30mL per side)
Other Names:
  • Exparel
Drug: Bupivacain
Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS. 30mL per side)
Other Names:
  • Bupivacaine HCL
Active Comparator: RSB/RSC Ropivacaine

Rectus Sheath Block: Total 60mL of 0.2% ropivacaine (3 vials) (30mL per side)

+ Rectus Sheath Catheter intermittent hourly boluses of 0.2% ropivacaine 10mL/hr per side
Drug: Ropivacaine
Total 60mLof 0.2% ropivacaine: (60mL of 0.2% ropivacaine (3 vials)
Other Names:
  • Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The maximum, average, minimum, and current pain scores at the end of the period 24-48 post-op hours
Time Frame: At the end of the 24 - 48 post-op hours
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 at the end of 24-48 post-op hours using the validated tool; Brief Pain Inventory-Short Form.
At the end of the 24 - 48 post-op hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time to extubation
Time Frame: From anesthesia end date and time to the date and time of extubation, assessed up to 168 postoperative hours
The time to extubation: from anesthesia end time to the time of removing the endotracheal tube in the Intensive Care Unit.
From anesthesia end date and time to the date and time of extubation, assessed up to 168 postoperative hours
Hospital readmission and ED visits
Time Frame: up to 2 weeks after discharge
Incidences of hospital readmission and emergency visits within 2 weeks after discharge
up to 2 weeks after discharge
Antiemetics use
Time Frame: Up to 168 postoperative hour
The time from the intraoperative standard of care antiemetic dose to the first postoperative use of antiemetic and the number of antiemetic use at any time throughout hospitalization up to 1 week.
Up to 168 postoperative hour
Patient satisfaction with pain management using CSAT
Time Frame: at the end of 168 postoperative hours and at 2 weeks after the 168 postoperative hours
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.
at the end of 168 postoperative hours and at 2 weeks after the 168 postoperative hours
Other postoperative pain scores.
Time Frame: Up to 168 postoperative hours and at 2 weeks after discharge
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 168 postoperative hours and at 2 weeks after discharge using the validated tool; Brief Pain Inventory-Short Form.
Up to 168 postoperative hours and at 2 weeks after discharge
Postoperative nausea and vomiting
Time Frame: Up to 168 postoperative hours
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)
Up to 168 postoperative hours
Quality of Recovery-40 Questionnaire
Time Frame: On postop day 4, postop day 7, and at 2 weeks after the 168 postoperative hours
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).
On postop day 4, postop day 7, and at 2 weeks after the 168 postoperative hours
Intraop, postop, and total opioid consumption
Time Frame: Up to discharge, assessed as 2 weeks
The intraoperative, postoperative, and total opioid consumption during hospitalization using morphine milliequivalent doses (MME) between the groups.
Up to discharge, assessed as 2 weeks
Hospital and Intensive Care Unit (ICU) length of stay (LOS)
Time Frame: From the date and time of admission to the date and time of discharge, up to 2 weeks.
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.
From the date and time of admission to the date and time of discharge, up to 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.
Time Frame: From the date of the block until the date of discharge, assessed up to 1 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.
From the date of the block until the date of discharge, assessed up to 1 week
Sensory function test
Time Frame: Up to the end of the 168 postoperative hour
to compare any difference in the sensory function test that will be performed at the site of the block and catheter at the ICU and every postoperative day up to the end of the 168 postoperative hours.
Up to the end of the 168 postoperative hour
The cost of care during hospitalization.
Time Frame: From the time of the blocks until the date of discharge, assessed as 2 weeks
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.)
From the time of the blocks until the date of discharge, assessed as 2 weeks
The time to the first rescue opioid.
Time Frame: Up to 168 postoperative hour
The time from the last intraoperative opioid given to the time of the first rescue opioid given after surgery is measured in hours.
Up to 168 postoperative hour
The time to first postop antiemetics
Time Frame: Up to 168 postoperative hour
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.
Up to 168 postoperative hour
Opioid use and refills within 2 weeks after hospital discharge
Time Frame: Up to 2 weeks after discharge
Opioid use and refills within 2 weeks after hospital discharge (yes or no)
Up to 2 weeks after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hartford Hospital

Investigators

  • Principal Investigator: Kevin Finkel, MD, Hartford Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2023

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHC-2023-0134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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