Back to resultsLiposomal Bupivacaine/Bupivacaine in RS Blocks vs. Ropivacaine in RS Blocks And Catheters (EXODUS)
Primary Purpose
Aortic Aneurysm, Abdominal, Abdominal Aortic Occlusion, Aortoiliac Occlusive Disease
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
Ropivacaine
Bupivacain
Sponsored by
About this trial
This is an interventional supportive care trial for Aortic Aneurysm, Abdominal focused on measuring Open abdominal aortic repair surgery, Rectus Sheath Block, Rectus Sheath Block and Catheter, Liposomal Bupivacaine, Exparel, Ropivacaine continuous infusion
Eligibility Criteria
Inclusion Criteria: Patients aged 18-80 years 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. Patients who are able to speak and read English Patients with American Society of Anesthesiology (ASA) physical status score I-IV 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: 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. 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. History of allergy to local anesthetics. 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. 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. 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. 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. Lack or refusal to sign the study consent. 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.
Sites / Locations
- Hartford HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RSB LB/B
RSB/RSC Ropivacaine
Arm Description
Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS) (30mL per side)
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
Outcomes
Primary Outcome Measures
The maximum, average, minimum, and current pain scores at the end of the period 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.
Secondary Outcome Measures
Other 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 168 postoperative hours and at 2 weeks after discharge using the validated tool; Brief Pain Inventory-Short Form.
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.
Intraop, postop, and total opioid consumption
The intraoperative, postoperative, and total opioid consumption during hospitalization using morphine milliequivalent doses (MME) between the groups.
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.
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.
Hospital readmission and ED visits
Incidences of hospital readmission and emergency visits within 2 weeks after discharge
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)
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).
Sensory function test
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.
Antiemetics use
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.
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.
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.)
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.
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.
Opioid use and refills within 2 weeks after hospital discharge
Opioid use and refills within 2 weeks after hospital discharge (yes or no)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05972018
Brief Title
Liposomal Bupivacaine/Bupivacaine in RS Blocks vs. Ropivacaine in RS Blocks And Catheters
Acronym
EXODUS
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2023 (Actual)
Primary Completion Date
October 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hartford Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
A prospective, single-center, open-label, interventional randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RSB LB/B
Arm Type
Experimental
Arm Description
Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS) (30mL per side)
Arm Title
RSB/RSC Ropivacaine
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
Rectus Sheath Block: Total 60mL: (20mL 1.3% Liposomal bupivacaine + 30mL 0.25% bupivacaine + 10mL NS).(30mL per side)
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
Total 60mLof 0.2% ropivacaine: (60mL of 0.2% ropivacaine (3 vials)
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Other Intervention Name(s)
Bupivacaine HCL
Intervention Description
Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS. 30mL per side)
Primary Outcome Measure Information:
Title
The maximum, average, minimum, and current pain scores at the end of the period 24-48 post-op hours
Description
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.
Time Frame
At the end of the 24 - 48 post-op hours
Secondary Outcome Measure Information:
Title
Other postoperative pain scores.
Description
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.
Time Frame
Up to 168 postoperative hours and at 2 weeks after discharge
Title
The time to extubation
Description
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 168 postoperative hours
Title
Intraop, postop, and total opioid consumption
Description
The intraoperative, postoperative, and total opioid consumption during hospitalization using morphine milliequivalent doses (MME) between the groups.
Time Frame
Up to discharge, assessed as 2 weeks
Title
Hospital and Intensive Care Unit (ICU) length of stay (LOS)
Description
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.
Title
The occurrence of block-related and catheter-related complications, or local anesthetics-related adverse events up to hospital discharge or up to one week.
Description
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
Title
Hospital readmission and ED visits
Description
Incidences of hospital readmission and emergency visits within 2 weeks after discharge
Time Frame
up to 2 weeks after discharge
Title
Postoperative nausea and vomiting
Description
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 168 postoperative hours
Title
Quality of Recovery-40 Questionnaire
Description
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, postop day 7, and at 2 weeks after the 168 postoperative hours
Title
Sensory function test
Description
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.
Time Frame
Up to the end of the 168 postoperative hour
Title
Antiemetics use
Description
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.
Time Frame
Up to 168 postoperative hour
Title
Patient satisfaction with pain management using CSAT
Description
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 the end of 168 postoperative hours and at 2 weeks after the 168 postoperative hours
Title
The cost of care during hospitalization.
Description
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
Title
The time to the first rescue opioid.
Description
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 168 postoperative hour
Title
The time to first postop antiemetics
Description
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 168 postoperative hour
Title
Opioid use and refills within 2 weeks after hospital discharge
Description
Opioid use and refills within 2 weeks after hospital discharge (yes or no)
Time Frame
Up to 2 weeks after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18-80 years
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.
Patients who are able to speak and read English
Patients with American Society of Anesthesiology (ASA) physical status score I-IV
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:
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.
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.
History of allergy to local anesthetics.
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.
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.
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.
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.
Lack or refusal to sign the study consent.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aseel Walker, MD
Phone
(860) 972-1778
Email
aseel.walker@hhchealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Finkel, MD
Organizational Affiliation
Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin J Finkel, MD
Email
kevin.finkel@hhchealth.org
First Name & Middle Initial & Last Name & Degree
Aseel Walker, MD
Phone
860-9772-1778
Email
Aseel.Walker@hhchealth.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Liposomal Bupivacaine/Bupivacaine in RS Blocks vs. Ropivacaine in RS Blocks And Catheters
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