← Back to Search

Dexamethasone for Diverticulosis Bleeding (TAP-DEX Trial)

Phase 1 & 2

Recruiting

Led By David N Ginther, MD

Research Sponsored by University of Saskatchewan

Eligibility Criteria Checklist

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

Must have

elective or urgent inpatient laparoscopic/laparoscopic assisted colorectal surgery.

age > 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60-120 minutes

Awards & highlights

TAP-DEX Trial Summary

This trial will assess if steroids help anesthetic to last longer during colorectal surgery.

Who is the study for?

This trial is for adults over 18 who are undergoing elective or urgent laparoscopic colorectal surgery. It's suitable for patients with a range of conditions from diverticulosis to colorectal cancer, as long as they're classified ASA I-III, indicating a certain level of surgical risk.Check my eligibility

What is being tested?

The study is testing the use of Dexamethasone alongside local anesthetics in transversus abdominis plane blocks during colorectal surgeries. The goal is to see if Dexamethasone can extend pain relief post-surgery.See study design

What are the potential side effects?

Dexamethasone may cause side effects like increased blood sugar levels, possible infection risks, and could affect mood or sleep patterns. Local anesthetic complications might include numbness beyond the target area or allergic reactions.

TAP-DEX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for or have had minimally invasive colorectal surgery.

Select...

I am older than 18 years.

TAP-DEX Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60-120 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60-120 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60-120 minutes for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Total postoperative opioid consumption in the first 48 hours after surgery (hydromorphone equivalents.

Secondary outcome measures

Length of stay in hospital (days).

Length of stay in post-anesthetic care unit (minutes).

Opioid consumption in the post-anesthetic care unit (PACU)

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Deep Vein Thrombosis

Cerebrospinal fluid leak

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

TAP-DEX Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DexamethasoneExperimental Treatment1 Intervention

Dexamethasone 16mg will be added to local anesthetic solution for TAP blocks. 4mg will be injected at 4 anterior abdominal wall sites in a laparoscopically-administered TAP block. This is a single intraoperative dose.

Group II: Local anesthetic onlyActive Control1 Intervention

Local anesthetic (bupivacaine 0.25) 1mL/kg will be used for TAP blocks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2590

0 / 2Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of SaskatchewanLead Sponsor

251 Previous Clinical Trials

154,350 Total Patients Enrolled

David N Ginther, MDPrincipal InvestigatorUniversity of Saskatchewan

Frequently Asked Questions

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

Are researchers accepting new participants for this experiment?

"Affirmative. As indicated in the records on clinicaltrials.gov, recruitment for this medical experiment is still ongoing since it was first posted on September 1st 2022 and last updated on November 30th 2023. A total of 60 participants are required from a single site."

Answered by AI

What is the upper limit of participants enrolled in this research initiative?

"Correct. The records on clinicaltrials.gov make clear that this medical research project, first published in September of 2022, is actively recruiting patients. 60 individuals must be enrolled from 1 location to complete the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transversus Abdominis Plane Blocks With and Without Dexamethasone

Nathan Ginther 2022. "Transversus Abdominis Plane Blocks With and Without Dexamethasone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05432934.

All > Diverticulitis > Crohns Disease