Bilateral TAP and RS Blocks Using Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy

NCT05224089 | Recruiting Phase 4 FDA Drug

• 1 other identifier: HHC-2021-0331
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be a single center, prospective triple blinded randomized controlled study, comparing the use of liposomal bupivacaine (Exparel) to regular bupivacaine with adjuncts in bilateral mid-abdominal transverse abdominis plane (TAP) blocks for patients undergoing laparoscopic colectomy procedures.

Conditions

Bowel Disease

Keywords

Liposomal Bupivacaine; Exparel; Bupivacaine; Laparoscopic Colectomy; Transverse Abdominis Plane Blocks (TAP); Regional anesthesia; Rectus Sheath Block

Outcome Measures

Primary Outcomes (1)

• The highest Numerical Pain Scores

  To compare the highest (worst) pain reported for the period of 48-72 hours post-surgery.

  3 days

Secondary Outcomes (9)

• The highest Numerical Pain Scores for the period of 0-47 hours

  up to 3 days

• All pain scores, mild-moderate-severe.

  up to 72 postoperative hours

• Postoperative opioid consumption measured in morphine MilliEquivalent (MME)

  Up to 6 days post surgery.

• Postoperative nausea/vomiting scores

  30 days

• Hospital and post-anesthesia care unit length of stay

  6 days

Study Arms (2)

Liposomal Bupivacaine/Bupivacaine HCL

EXPERIMENTAL

20mL 1.3% Exparel (266mg) + 60mL 0.25% bupivacaine (150mg) + 20mL normal saline. Total 100mL divided into 10mL syringes, 30 mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.

Drug: Liposomal Bupivicaine/Bupivacaine Admixture; Drug: Bupivacaine HCL

Regular Bupivacaine Arm

ACTIVE COMPARATOR

80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL of normal saline. Total 100mL divided into 10mL syringes, 30mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.

Drug: Bupivacaine HCL

Interventions

Liposomal Bupivicaine/Bupivacaine Admixture DRUG

60mL of 0.25% Bupivacaine (150mg)+ 20 mL of 1.3% Exparel (266 mg)+20mL NS=100mL

Also known as: Bupivacaine

Liposomal Bupivacaine/Bupivacaine HCL

Bupivacaine HCL DRUG

80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL NS= 100mL

Also known as: Dexamethasone 0.5 ml (5 mg), Epinephrine 0.1 ml

Liposomal Bupivacaine/Bupivacaine HCL; Regular Bupivacaine Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective laparoscopic colectomy surgery to be performed by one of the 4 colorectal surgeons in the study.
• English speaking patients
• Patients with American Society of Anesthesiology (ASA) physical status score I- IV

You may not qualify if:

• Emergency laparoscopic colectomy surgery
• Patients with distant metastatic cancers (e.g. bone, lung, brain).
• Scheduled for multi organs resection surgery in addition to colectomy.
• Patients with contraindications to TAP or RS blocks including but not limited to anatomical abnormality, previous surgical intervention that limits or prevents receiving bilateral TAP blocks (e.g. surgical mesh at the site of TAP or RS block), or infection at the injection site.
• Current colostomies.
• History of allergy to local anesthetics.
• Coagulopathy or coagulation disorder. Also patients who are receiving antithrombotic medications as a contraindication to receiving single shot peripheral nerve blockade as per the most recent American Society of Regional Anesthesiology (ASRA) guidelines.16
• Weight \< 40 kg, as 40 mL of Bupivacaine 0.25%, or combination of 20 mL of bupivacaine 0.25% with 20 mL of liposomal bupivacaine is greater than the maximal dose allowed, given concern for local anesthetic toxicity.
• Patients who take long acting opioid medication, or on continuous opioid \> 50 MME per day for at least 30 days within 90 days prior to surgery. Also patients who have chronic pain syndrome with a recent preoperative consultation to the chronic pain service.
• Patients with current substance abuse, or history of substance abuse within 3 months, this includes any illicit drugs or excessive alcohol consumption as defined 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.15
• Pregnant, nursing, or planning to become pregnant during the study or within 1 month postoperatively
• Refusal or lack of providing the study consent

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

Related Publications (20)

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• Stokes AL, Adhikary SD, Quintili A, Puleo FJ, Choi CS, Hollenbeak CS, Messaris E. Liposomal Bupivacaine Use in Transversus Abdominis Plane Blocks Reduces Pain and Postoperative Intravenous Opioid Requirement After Colorectal Surgery. Dis Colon Rectum. 2017 Feb;60(2):170-177. doi: 10.1097/DCR.0000000000000747.

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  BACKGROUND

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MeSH Terms

Conditions

Intestinal Diseases

Interventions

Bupivacaine; Dexamethasone; Epinephrine

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Kevin Finkel, MD

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aseel Walker, MD

CONTACT

860-972-1778; aseel.walker@hhchealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Triple (Participant, Care Provider, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research - HH Department of Anesthesiology

Model Details: single-center, prospective, triple blinded, randomized, controlled trial.

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: February 4, 2022
• Study Start: April 27, 2022
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)