- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07424599
Effect of Dexmedetomidine Versus Dexamethasone as Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Plane Block on Postoperative Analgesia in Myasthenic Patients Undergoing Thoracoscopic Thymectomy
February 15, 2026 updated by: RAMY AHMED, Ain Shams University
This current comparative study involved 54 patients undergoing thoracoscopic thymectomy who were distributed randomly into three equal groups to receive ultrasound (US)-guided ESPB using 20 ml bupivacaine 0.25% (group B) , 20 ml bupivacaine 0.25% with 8 mg dexamethasone (group BS), 20 ml bupivacaine 0.25% with dexmedetomidine 1mcg/kg (group BM).
The time till the first postoperative rescue analgesic requested was the primary outcome.
The secondary outcomes included the postoperative pain scores and analgesic consumption.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
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
- Name: Ramy Mahrose
- Phone Number: 01281431097
- Email: Ramy.ahmed@med.asu.edu.eg
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
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- myasthenic patients
- American Society of Anesthesiologists (ASA) physical grade of 2-3)
- who underwent video assisted thoracoscopic thymectomy
Exclusion Criteria:
- Refused participation in the study,
- known allergy for this study drugs ,
- Contraindication to the ESPB as infection at block site & marked chest cage deformity,
- significant bleeding disorders ,
- patients with significant renal or liver dysfunction,
- heart block ,
- poor ventilatory function,
- severe chronic obstructive pulmonary disease,
- morbid obesity,
- mental disability, or communication difficulties that hindered effective pain assessment,
- Individuals who was converted to open thoracotomy or those re-explorated for surgical related issues.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: (group B)
ultrasound (US)-guided ESPB using 20 ml bupivacaine 0.25%
|
An echogenic 21 gauge 10 cm needle was introduced in caudo-cephalic orientation utilizing the in-plane approach and traversing through trapezius, rhomboid, and erector spinae muscles till reaching the transverse process then slightly withdrawn and hydrodissection was done by 3 mL of saline 0.9% to verify the accurate implantation of the block needle tip between the erector spinae muscle and the transverse process (the erector spinae plane).
Incremental LA injection was verified through US observation for the upward displacement and lifting of erector spinae muscle from the transverse process with craniocaudal spread of the LA in the targeted plane.
The LA increments were one ml every 5 seconds with intermittent aspiration every 5 mL to avoid intravascular injection.
|
|
Active Comparator: Group BS
20 ml bupivacaine 0.25% with 8 mg dexamethasone
|
An echogenic 21 gauge 10 cm needle was introduced in caudo-cephalic orientation utilizing the in-plane approach and traversing through trapezius, rhomboid, and erector spinae muscles till reaching the transverse process then slightly withdrawn and hydrodissection was done by 3 mL of saline 0.9% to verify the accurate implantation of the block needle tip between the erector spinae muscle and the transverse process (the erector spinae plane).
Incremental LA injection was verified through US observation for the upward displacement and lifting of erector spinae muscle from the transverse process with craniocaudal spread of the LA in the targeted plane.
The LA increments were one ml every 5 seconds with intermittent aspiration every 5 mL to avoid intravascular injection.
|
|
Active Comparator: Group BM
20 ml bupivacaine 0.25% with dexmedetomidine 1mcg/kg
|
An echogenic 21 gauge 10 cm needle was introduced in caudo-cephalic orientation utilizing the in-plane approach and traversing through trapezius, rhomboid, and erector spinae muscles till reaching the transverse process then slightly withdrawn and hydrodissection was done by 3 mL of saline 0.9% to verify the accurate implantation of the block needle tip between the erector spinae muscle and the transverse process (the erector spinae plane).
Incremental LA injection was verified through US observation for the upward displacement and lifting of erector spinae muscle from the transverse process with craniocaudal spread of the LA in the targeted plane.
The LA increments were one ml every 5 seconds with intermittent aspiration every 5 mL to avoid intravascular injection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the duration between the surgery end and the 1st rescue analgesia the patient requested.
Time Frame: 24 hours postoperatively
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
.Total ketorolac consumption
Time Frame: 24 hours postoperatively
|
24 hours postoperatively
|
|
. Number of patients needed rescue tramadol
Time Frame: 24 hours postoperatively
|
24 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 15, 2026
Primary Completion (Estimated)
September 15, 2026
Study Completion (Estimated)
September 15, 2026
Study Registration Dates
First Submitted
February 15, 2026
First Submitted That Met QC Criteria
February 15, 2026
First Posted (Actual)
February 20, 2026
Study Record Updates
Last Update Posted (Actual)
February 20, 2026
Last Update Submitted That Met QC Criteria
February 15, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRM 3
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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