Two Doses of Dexmedetomidine as Adjuvent to Bupivacaine in Tap Block (Dexmed/tap)

October 2, 2024 updated by: Kerolos Salama Tawfeek, Assiut University

Comparing the Analgesic Effect of Two Different Doses of Dexmedetomidine Added to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block in Patients Undergoing Lower Abdominal Cancer Surgeries; A Randomized Clinical Trial

The aim of this study to determine the optimal dose of dexmedetomidine as an adjuvant to bupivacaine in U.S guided TAP block for preemptive analgesia In patients undergoing lower abdominal cancer surgeries.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The transversus abdominis plane (TAP) involves innervations of the anterolateral abdominal wall derived from T6-L1. The block can be given either by anatomical landmark technique or by using an ultrasound probe. The local anesthetic is deposited in a plane between internal oblique and transversus abdominis muscle. It provides adequate postoperative analgesia following various abdominal surgeries.Dexmedetomidine is an alpha-2 agonist that has been approved as a venous sedative and an adjuvant for pain relief .In previous studies, the addition of dexmedetomidine to bupivacaine in the TAP block has prolonged the effect of this block . So far, the optimal dose of dexmedetomidine for the TAP block has not been determined.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

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 Backup

Study Locations

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age from 18 to 65 years old
  • lower abdominal cancer surgery

Exclusion Criteria:

  • patient refusal
  • the local anesthetic allergy
  • coagulopathy
  • local infection at the procedure site
  • psychic patients
  • patient on chronic opioid use

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: tap block with 0.5 μg/kg dexmedetomidine
will receive pre-emptive ultrasound-guided tap block with 0.5 μg/kg dexmedetomidine in 20 ml volume added to 20 mL of 0.25% bupivacaine (40 ml in total) 20 ml will be applied on each side of the abdominal wall after induction of GA.
Drug: Dexmedetomidine as adjuvent to bupvacaine in tap block
The analgesic effect of Two different doses of dexmedetomidine as adjuvent to bupivacaine in tap block
Other Names:
  • Precedex
Active Comparator: tap block with 1.5 μg/kg dexmedetomidine
will receive pre-emptive ultrasound-guided tap block with 1.5 μg/kg dexmedetomidine in 20 ml volume added to 20 mL of 0.25% bupivacaine (40 ml in total) 20 ml will be applied on each side of the abdominal wall after induction of GA.
Drug: Dexmedetomidine as adjuvent to bupvacaine in tap block
The analgesic effect of Two different doses of dexmedetomidine as adjuvent to bupivacaine in tap block
Other Names:
  • Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total morphine consumption during the first 24 hours postoperatively
Time Frame: First 24 hours postoperative
Morphine consumption during the First 24 hours postoperative
First 24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of pain using Visual analogue scale
Time Frame: First 24 hours postoperative
The severity of pain at rest and on coughing will be assesd using a 10-cm vas(0 means no pain ,10 means worst pain)
First 24 hours postoperative
Patient level of sedation using four point modified ramsy scale
Time Frame: First 24 hours postoperative
using a 4-point scale (0 = awake and alert, 1 = minimally sedated, responds to speech, 2 = moderately sedated, arousable by tactile stimulation, and 3 = deeply sedated, arousable only by painful stimulation)
First 24 hours postoperative

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Principal Investigator: Kerolos S Tawfeek, Assiut University

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 (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

September 28, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

October 3, 2024

Last Update Submitted That Met QC Criteria

October 2, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-2024-200895

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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