Transverse Abdominus Plane Block Study (TAP)

March 3, 2023 updated by: University of Colorado, Denver

Effect of Laparoscopic-Guided Transversus Abdominus Plane (TAP) Block on Opioid Consumption Using Dual-Adjunct Therapy With Dexmedetomidine and Dexamethasone Versus Liposomal Bupivacaine (Exparel®) Following Minimally Invasive Colorectal Surgery: A Single-Blinded Randomized Clinical Trial.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Samuel Lai
  • Phone Number: 410-676-8549

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University Of Colorado Hospital
        • Contact:
        • Principal Investigator:
          • Brandon Chapman
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Rocky Mountain Regional VA Medical Center
        • Contact:
        • Principal Investigator:
          • Brandon Chapman
      • Highlands Ranch, Colorado, United States, 80129

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Combination product: 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
Active Comparator: 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).
Drug: Liposomal bupivacaine
Liposomal bupivacaine, 20 mL (13.3 mg/ml) (266 mg) Normal saline 0.9%, 40mL
Other Names:
  • Exparel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Post-operative opioid consumption in the first 72 hours
Time Frame: 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
Time Frame: 2 months
Total morphine dose equivalents administered throughout hospital stay
2 months
Visual analog scale pain scores in the PACU
Time Frame: 72 hours
Visual analog scale (VAS) pain scores in the PACU
72 hours
Visual analog scale pain scores 12 hours post op
Time Frame: 12 hours
Visual analog scale pain scores 12 hours post op
12 hours
Visual analog scale pain scores 24 hours post op
Time Frame: 24 hours
Visual analog scale pain scores 24 hours post op
24 hours
Visual analog scale pain scores 36 hours post op
Time Frame: 36 hours
Visual analog scale pain scores 36 hours post op
36 hours
Visual analog scale pain scores 48 hours post op
Time Frame: 48 hours
Visual analog scale pain scores 48 hours post op
48 hours
Visual analog scale pain scores 72 hours post op
Time Frame: 72 hours
Visual analog scale pain scores 72 hours post op
72 hours
Epidural need
Time Frame: 2 months
Need for an epidural post-operatively. Reviewed using the EMR.
2 months
Need for postoperative patient-controlled analgesia (PCA)
Time Frame: 72 hours
Determined by review of EMR. Patients use or non-use of PCA.
72 hours
Need for adjunctive systemic nonopioid pain medications
Time Frame: 2 months
Adjunctive systemic nonopioid pain medications
2 months
Prescribed opioid at discharge
Time Frame: 2 months
Amount of opioid prescribed at discharge
2 months
Outpatient narcotic refill
Time Frame: 2 months
Use the EMR to determine outpatient narcotic refill
2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: 2 months
To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on length of hospital stay following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Calculating the length of hospital stay will allow for evaluation of effectiveness of dual adjunct therapy in context of ERAS protocol compared to liposomal bupivacaine
2 months
Use of antiemetics in the first 12 hours post op
Time Frame: 12 hours
To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR.
12 hours
Use of antiemetics in the first 24 hours post op
Time Frame: 24 hours
To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR.
24 hours
Use of antiemetics in the first 36 hours post op
Time Frame: 36 hours
To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR.
36 hours
Use of antiemetics in the first 48 hours post op
Time Frame: 48 hours
To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR.
48 hours
Use of antiemetics in the first 72 hours post op
Time Frame: 72 hours
To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Antiemetic dosage reviewed using the EMR.
72 hours
Time to first flatus
Time Frame: 2 months
Days from surgery to first flatus postoperatively. Reviewed using the EMR.
2 months
Time to first bowel movement
Time Frame: 2 months
Days from surgery to first bowel movement postoperatively. Reviewed using the EMR.
2 months
Need to insert nasogastric tube
Time Frame: 2 months
To assess the impact of laparoscopic guided TAP blocks and dual-adjunct therapy on return of bowel function following minimally invasive (laparoscopic or robotic) surgery of the colon and rectum. Reviewed using the EMR.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brandon C Chapman, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-2574.cc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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