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Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline for Surgery (TAP Trial)

Phase 2

Waitlist Available

Led By Brandon C Chapman

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months

Awards & highlights

TAP Trial Summary

This trial will study whether a laparoscopic guided TAP block, which is a type of local anesthesia, can help reduce opioid consumption and costs in patients who undergo elective minimally invasive colorectal surgery.

Eligible Conditions

Colorectal Disorders
Surgery

TAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Epidural need

Need for adjunctive systemic nonopioid pain medications

Need for postoperative patient-controlled analgesia (PCA)

+10 more

Secondary outcome measures

Length of hospital stay

Need to insert nasogastric tube

Time to first bowel movement

+6 more

TAP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Investigational ArmExperimental Treatment1 Intervention

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. 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

Group II: Liposomal Bupivacaine (Exparel)Active Control1 Intervention

The study drug for patients in the treatment arm #2 will be a mixture of liposomal bupivacaine and bupivacaine 0.25% as follows: Liposomal bupivacaine, 20 mL (13.3 mg/ml) (266 mg) Normal saline 0.9%, 40mL The total volume to be injected in each patient will be 60 mL (see below for different treatment arms).

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Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,583 Total Patients Enrolled

4 Trials studying Surgery

1,360 Patients Enrolled for Surgery

Brandon C ChapmanPrincipal InvestigatorUniversity of Colorado, Denver

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please share any safety concerns around the Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline cocktail?

"So far, data collected suggests that Ropivacaine, Dexmedetomidine, Dexamethasone sodium phosphate, Normal saline is safe enough to receive a score of 2."

Answered by AI

What are the desired outcomes of this research?

"The purpose of this 72-hour study is to observe the effects of laparoscopic guided TAP blocks and dual-adjunct therapy on postoperative bowel function in patients who have undergone minimally invasive surgery of the colon and rectum. Secondary outcomes being monitored include antiemetic usage and the need for nasogastric tube insertion within the first 48 and 72 hours post-op, respectively."

Answered by AI

Does this experiment allow people over the age of 40 to participate?

"In order to be eligible for this clinical trial, patients must between 18-100 years old. There are currently 32 trials underway for minors and 255 involving elderly patients."

Answered by AI

How many people are total are included in this experiment?

"That is correct, the online clinicaltrials.gov database currently has this trial listed as recruiting patients. This particular study was posted on April 19th, 2022 and was last updated on August 1st, 2022. They are hoping to enroll 110 individuals from 3 separate locations."

Answered by AI

Are new participants being recruited for this trial at this time?

"Yes, the information on clinicaltrials.gov point out that this clinical trial is actively looking for patients. The study was initially posted on 4/19/2022 and was most recently edited on 8/1/2022. The trial is looking for 110 patients at 3 sites."

Answered by AI

Does my health profile correspond with the prerequisites for this research?

"This trial is looking for 110 participants, aged 18-100, who have already undergone surgery. In addition to this broad criteria, potential patients must also be willing and able to sign the consent form, comply with study procedures, and be available for the duration of the study. Male and female patients are both welcome."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transverse Abdominus Plane Block Study

2022. "Transverse Abdominus Plane Block Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05216055.