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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHartford Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Liposomal bupivacaine

    Drug

    Rectus Sheath Block: Total 60mL: (20mL 1.3% Liposomal bupivacaine + 30mL 0.25% bupivacaine + 10mL NS).(30mL per side)

  • Ropivacaine

    Drug

    Total 60mLof 0.2% ropivacaine: (60mL of 0.2% ropivacaine (3 vials)

  • Bupivacain

    Drug

    Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS. 30mL per side)

Treatment groups

14 Participants
are divided into 2 treatment groups
Group A: RSB LB/BExperimental treatment 2 interventions
Group B: RSB/RSC RopivacaineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

1

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
2

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
3

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
4

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.

Other outcomes

Sponsors and contacts

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