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

Aortic Aneurysm, Abdominal Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05972018
• Other study ID #: HHC-2023-0134
• Status: Recruiting
• Phase: Phase 4
• Start date: October 18, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: October 2023
• Source: Hartford Hospital
• Contact: Aseel Walker, MD
• Phone: (860) 972-1778
• Email: aseel.walker[@]hhchealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Diseases
• Aortoiliac Occlusive Disease

Intervention

Drug:
• Liposomal bupivacaine
Rectus Sheath Block: Total 60mL: (20mL 1.3% Liposomal bupivacaine + 30mL 0.25% bupivacaine + 10mL NS).(30mL per side)
• Ropivacaine
Total 60mLof 0.2% ropivacaine: (60mL of 0.2% ropivacaine (3 vials)
• Bupivacain
Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS. 30mL per side)

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the end of the 24 - 48 post-op hours
Secondary	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.	Up to 168 postoperative hours and at 2 weeks after discharge
Secondary	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.	From anesthesia end date and time to the date and time of extubation, assessed up to 168 postoperative hours
Secondary	Intraop, postop, and total opioid consumption	The intraoperative, postoperative, and total opioid consumption during hospitalization using morphine milliequivalent doses (MME) between the groups.	Up to discharge, assessed as 2 weeks
Secondary	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.	From the date and time of admission to the date and time of discharge, up to 2 weeks.
Secondary	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.	From the date of the block until the date of discharge, assessed up to 1 week
Secondary	Hospital readmission and ED visits	Incidences of hospital readmission and emergency visits within 2 weeks after discharge	up to 2 weeks after discharge
Secondary	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)	Up to 168 postoperative hours
Secondary	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).	On postop day 4, postop day 7, and at 2 weeks after the 168 postoperative hours
Secondary	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.	Up to the end of the 168 postoperative hour
Secondary	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.	Up to 168 postoperative hour
Secondary	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.	at the end of 168 postoperative hours and at 2 weeks after the 168 postoperative hours
Secondary	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.)	From the time of the blocks until the date of discharge, assessed as 2 weeks
Secondary	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.	Up to 168 postoperative hour
Secondary	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.	Up to 168 postoperative hour
Secondary	Opioid use and refills within 2 weeks after hospital discharge	Opioid use and refills within 2 weeks after hospital discharge (yes or no)	Up to 2 weeks after discharge