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

Sponsor

Hartford Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05972018

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this randomized clinical trial is to learn about receiving a single dose of liposomal bupivacaine/bupivacaine mixture through bilateral rectus sheath blocks compared to the standard of care in patients undergoing vascular surgery with an open mid-abdominal laparotomy incision. The main question it aims to answer is to determine 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) to see if there is a difference in outcomes such as postoperative pain scores, opioid consumption, hospital and PACU length of stay, patient's satisfaction, and quality of recovery. Additionally, to compare the resources consumed by each intervention, specifically the medication cost (ropivacaine vs. LB/bupivacaine mixture), block and catheter supply, and the length of staff time providing rectus sheath block and catheter over the hospital stay.

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm, Abdominal Abdominal Aortic Occlusion Aortoiliac Occlusive Disease Aortic Diseases	Drug: Liposomal bupivacaine Drug: Ropivacaine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A prospective, single-center, open-label, interventional randomized controlled trialA prospective, single-center, open-label, interventional randomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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% LB + 30mL 0.25% bupivacaine + 10mL NS. 30mL per side) Other Names: Bupivacaine
Active Comparator: RSB/RSC Ropivacaine Rectus Sheath Block: Total 60mL (30mL of 0.5% ropivacaine (1 vial)+ 30mL normal saline + 0.1 mL Epinephrine 1:400,000) Rectus Sheath Catheter continuous infusion of 0.2% ropivacaine 10mL/hr per side 0.2% ropivacaine boluses of 20mL per side per day	Drug: Ropivacaine Total 60mLof 0.25% ropivacaine: (30mL of 0.5% ropivacaine (1 vial)+ 30mL normal saline + 0.1 mL Epinephrine 1:400,000) Other Names: Epinephrine

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% LB + 30mL 0.25% bupivacaine + 10mL NS. 30mL per side)

Other Names:

Bupivacaine

Active Comparator: RSB/RSC Ropivacaine

Rectus Sheath Block: Total 60mL (30mL of 0.5% ropivacaine (1 vial)+ 30mL normal saline + 0.1 mL Epinephrine 1:400,000) Rectus Sheath Catheter continuous infusion of 0.2% ropivacaine 10mL/hr per side 0.2% ropivacaine boluses of 20mL per side per day

Drug: Ropivacaine

Total 60mLof 0.25% ropivacaine: (30mL of 0.5% ropivacaine (1 vial)+ 30mL normal saline + 0.1 mL Epinephrine 1:400,000)

Other Names:

Epinephrine

Outcome Measures

Primary Outcome Measures

The maximum, average, minimum, and current pain scores at the end of the period 24-48 post-op hours [At the end of the 24 - 48 post-op hours]
The maximum, average, minimum, and current pain scores reported by participants at the end of 24-48 post-op hours using the brief pain inventory-short form (BPI-SF).

Secondary Outcome Measures

Other postoperative pain scores. [Up to 168 postoperative hours and at 2 weeks after discharge]
The maximum, average, minimum, and current pain scores daily up to the end of the 168 postoperative hours and 2 weeks after discharge using the BPI-SF.
The time to extubation [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.
Intraop, postop, and total opioid consumption [Up to 2 weeks after discharge]
The intraoperative, postoperative, and total opioid consumption during hospitalization measured using morphine milliequivalent doses (MME). Also, if any difference in the time from last opioid given intraop. to the first rescue opioid after surgery. Finally, to compare the incidence of opioid refills, and opioid use (yes/no) at 2 weeks after discharge between the groups.
Hospital and Post Anesthesia Care Unit (PACU) or Intensive Care Unit (ICU) length of stay (LOS) [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 PACU or ICU stays, in addition to the duration of hospitalization if > or < 7 days.
The safety of the study interventions [From the date of the block until the date of discharge, assessed up to 1 week]
Determine whether patients receiving ropivacaine in RSC versus B/LB in RSB have any difference in the safety of the study interventions by reporting the occurrence of block or catheter related complications up to hospital discharge or up to one week.
Hospital readmission and ED visits [up to 2 weeks after discharge]
Incidences of hospital readmission and emergency visits within 2 weeks after discharge
Postoperative nausea and vomiting (PONV) [Up to 168 postoperative hours]
Compare the occurrence of postoperative nausea and vomiting (PONV) simplified PONV Impact Scale daily during hospitalization.
Quality of Recovery (QoR-40) Questionnaire [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 QoR-40 questionnaire with the 5 domains of pain, physical independence, psychological support, physical comfort, and emotional status at POD4, POD7, and 2 weeks post-discharge.
Sensory function test [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 PACU and every postoperative day up to the end of the 168 postoperative hours.
Antiemetics use [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.
Patient satisfaction with pain management using CSAT [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients age 18-80 years
Patients scheduled for elective vascular surgery with an open mid-abdominal laparotomy incision
Patients who are able to speak and read English
Patients with American Society of Anesthesiology (ASA) physical status score I-IV

Exclusion Criteria:

Emergency vascular reconstruction surgery.
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.
Patients with a current bleeding disorder or active ongoing coagulopathy and/or current coagulopathic at the time of surgery due to anticoagulants or antiplatelet use.
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.