Dexmedetomidine in Sonographic Guided Erector Spinae Plane Block

March 21, 2025 updated by: Mahmoud Faisal, Assiut University

Effect of Different Doses of Dexmedetomidine Added to Local Anesthetic in Sonographic Guided Erector Spinae Plane Block for Pain Management After Renal Surgeries : Randomized Clinical Trial

to investigate the postoperative analgesic effect of dexmedetomidine addition with different doses as an adjuvant to bupivacaine to Erector spinae plane block after renal surgeries.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Locations

  • Egypt
    • Assiut Governorate
      • Assiut, Assiut Governorate, Egypt, 71111
        • Recruiting
        • Assiut University Hospitals
        • Contact:

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 between 18 and 70 years.
  • Both sexes, males and females.
  • Patients with the American Society of Anesthesiologists (ASA) physical status I/II.
  • Body mass index (BMI) of 18-35 kg/m2
  • Patients scheduled for elective Renal or Percutaneous Nephrolithotomy.

Exclusion Criteria:

  • Patients under 18 years.
  • Patient refusal of nerve block.
  • Infection at the site of injection.
  • Coagulopathy.
  • Allergy to used medications.
  • Psychiatric disorder or chronic pain syndromes.
  • Chronic opioid use or substance abuse.
  • Quadriplegic patients.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low dose dex
0.5 mic/kg of dexmedetomidine administered
Drug: Dexmedetomidine
different doses of dexmedetomidine added to bupivacaine in erector spinae plane block
Experimental: intermediate dose dex
0.75 mic/kg of dexmedetomidine administered
Drug: Dexmedetomidine
different doses of dexmedetomidine added to bupivacaine in erector spinae plane block
Experimental: high dose dex
1 mic/kg of dexmedetomidine administered
Drug: Dexmedetomidine
different doses of dexmedetomidine added to bupivacaine in erector spinae plane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative analgesic duration
Time Frame: 24 hours
postoperative analgesic duration with each dose
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: 24 hours
severity of pain using visual analogue pain score
24 hours
side effects
Time Frame: 24 hours
as hemodynamic effect as (hypotension, bradycardia), nausea and vomiting.
24 hours
dynamic pain score
Time Frame: 24 hours
Dynamic visual analogue pain score (pain with cough, deep breath, and movement)
24 hours

Collaborators and Investigators

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

Sponsor

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 (Actual)

October 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 16, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-2024-200943

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

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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