Transverse Abdominus Plane Block Study

NCT05216055 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 20-2574.cc
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Disorders; Surgery

Keywords

Benign; Malignant; Laparoscopic Surgery; Robotic Surgery; Hybrid Surgery

Outcome Measures

Primary Outcomes (13)

• Post-operative opioid consumption in the first 72 hours

  Total amount of both intravenous and oral opioid use in the first 72 hours after surgery measured in morphine milligram equivalents.

  72 hours

• Post-operative opioid consumption over hospital stay

  Total morphine dose equivalents administered throughout hospital stay

  2 months

• Visual analog scale pain scores in the PACU

  Visual analog scale (VAS) pain scores in the PACU

  72 hours

• Visual analog scale pain scores 12 hours post op

  Visual analog scale pain scores 12 hours post op

  12 hours

• Visual analog scale pain scores 24 hours post op

  Visual analog scale pain scores 24 hours post op

  24 hours

• Visual analog scale pain scores 36 hours post op

  Visual analog scale pain scores 36 hours post op

  36 hours

• Visual analog scale pain scores 48 hours post op

  Visual analog scale pain scores 48 hours post op

  48 hours

• Visual analog scale pain scores 72 hours post op

  Visual analog scale pain scores 72 hours post op

  72 hours

• Epidural need

  Need for an epidural post-operatively. Reviewed using the EMR.

  2 months

• Need for postoperative patient-controlled analgesia (PCA)

  Determined by review of EMR. Patients use or non-use of PCA.

  72 hours

• Need for adjunctive systemic nonopioid pain medications

  Adjunctive systemic nonopioid pain medications

  2 months

• Prescribed opioid at discharge

  Amount of opioid prescribed at discharge

  2 months

• Outpatient narcotic refill

  Use the EMR to determine outpatient narcotic refill

  2 months

Secondary Outcomes (9)

• Length of hospital stay

  2 months

• Use of antiemetics in the first 12 hours post op

  12 hours

• Use of antiemetics in the first 24 hours post op

  24 hours

• Use of antiemetics in the first 36 hours post op

  36 hours

• Use of antiemetics in the first 48 hours post op

  48 hours

Study Arms (2)

Investigational Arm

EXPERIMENTAL

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

Combination Product: Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline

Liposomal Bupivacaine (Exparel)

ACTIVE COMPARATOR

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).

Drug: Liposomal bupivacaine

Interventions

Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline 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

Investigational Arm

Liposomal bupivacaine DRUG

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

Also known as: Exparel

Liposomal Bupivacaine (Exparel)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

MeSH Terms

Interventions

Ropivacaine; Dexmedetomidine; dexamethasone 21-phosphate; Saline Solution

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Brandon C Chapman

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study is a randomized single blinded trial to minimize bias and provide highest level of evidence in use as part of effort to reduce opioid use consumption. This study cannot be performed as a double blinded RCT due to Exparel being milky white color in appearance and cannot be altered or shielded from being visible by the operating surgeon performing the TAP block.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 31, 2022
• Study Start: April 19, 2022
• Primary Completion: December 16, 2022
• Study Completion: December 27, 2022
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share