Transverse Abdominus Plane Block Study

NCT ID: NCT05216055

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-19
• Study Completion Date: 2022-12-27

Brief Summary

Study the effect of laparoscopic guided TAP block on opioid consumption and associated costs using a mixture of dexmedetomidine, dexamethasone, and ropivacaine versus Liposomal bupivacaine (Exparel®) in patients who undergo elective minimally invasive colorectal surgery.

Detailed Description

This is a non-inferiority single-blinded randomized trial aiming to study the effect of laparoscopic guided TAP block on opioid consumption and associated costs using a mixture of dexmedetomidine, dexamethasone, and ropivacaine versus Liposomal bupivacaine (Exparel®) in patients who undergo elective minimally invasive colorectal surgery. This study aims to continue improving our current hospital wide effort in reducing opioid consumption and, consequently, the acute and long-term consequences of opioids. It will also complement the current ongoing efforts of the Department of Surgery's quality and safety improvement project in opioid stewardship. Additionally, this dual adjunct TAP solution combination is inexpensive ($28 per injection) and may result in a significant cost savings for the hospital.

Conditions

Colorectal Disorders; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Investigational Arm

The study drug volume, concentration, and dose of treatment arm #1 selected is based on the Principal Investigator's prior experience recommendations by the Food Drug Administration (FDA), and evidence based on prior literature. The final concentration of ropivacaine is 0.375% and final volume of the mixture is 60mL.

1. Ropivacaine 0.5% HCl, 40 mL (5 mg per mL) (200 mg)

2. Dexmedetomidine HCl, 0.50 ml (100 ug per mL) (50 ug)

3. Dexamethasone sodium phosphate, 1 mL (10 mg per mL) (10 mg)

4. Normal saline 0.9%, 18.5mL

Group Type: EXPERIMENTAL

Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline

Intervention Type: COMBINATION_PRODUCT

Ropivacaine 0.5% HCl, 40 mL (5 mg per mL) (200 mg) Dexmedetomidine HCl, 0.50 ml (100 ug per mL) (50 ug) Dexamethasone sodium phosphate, 1 mL (10 mg per mL) (10 mg) Normal saline 0.9%, 18.5mL

Liposomal Bupivacaine (Exparel)

The study drug for patients in the treatment arm #2 will be a mixture of liposomal bupivacaine and bupivacaine 0.25% as follows:

1. Liposomal bupivacaine, 20 mL (13.3 mg/ml) (266 mg)

2. Normal saline 0.9%, 40mL The total volume to be injected in each patient will be 60 mL (see below for different treatment arms).

Group Type: ACTIVE_COMPARATOR

Liposomal bupivacaine

Intervention Type: DRUG

Liposomal bupivacaine, 20 mL (13.3 mg/ml) (266 mg) Normal saline 0.9%, 40mL

Interventions

Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline

Ropivacaine 0.5% HCl, 40 mL (5 mg per mL) (200 mg) Dexmedetomidine HCl, 0.50 ml (100 ug per mL) (50 ug) Dexamethasone sodium phosphate, 1 mL (10 mg per mL) (10 mg) Normal saline 0.9%, 18.5mL

Intervention Type: COMBINATION_PRODUCT

Liposomal bupivacaine

Liposomal bupivacaine, 20 mL (13.3 mg/ml) (266 mg) Normal saline 0.9%, 40mL

Intervention Type: DRUG

Other Intervention Names

Exparel

Eligibility Criteria

Inclusion Criteria

• provision to sign and date the consent form.
• stated willingness to comply with all study procedures and be available for the duration of the study.
• Male and female patients aged 18 and older
• Benign or malignant colorectal disease undergoing laparoscopic, robotic, or a "hybrid" (minimally invasive dissection with a 6-8 cm incision to complete the surgery) colorectal resection with or without an ostomy

Exclusion Criteria

• Pregnant or breastfeeding patients
• Medical conditions that may interfere with the use of the study medications (e.g., drug allergy),
• Patients with opioid dependence defined as chronic opioid use more than 3 times per week preoperatively
• Incarcerated individuals
• Age less than 18 years-old
• Urgent/emergent operations as defined by need for operation within 24 hours
• Other conditions or general disability or infirmity that in the opinion of the investigator precludes further participation in the study.
• Enrollment in another concurrent study with use of investigational drugs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brandon C Chapman

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Other Identifiers

20-2574.cc

Identifier Type: -

Identifier Source: org_study_id