Postoperative Pain, AcuteNCT07424599
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
A study testing Erector Spinae Plane Block in people with Postoperative Pain, Acute, run by Ain Shams University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- myasthenic patients
- American Society of Anesthesiologists (ASA) physical grade of 2-3)
- who underwent video assisted thoracoscopic thymectomy
Who cannot join
- 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 ,
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Postoperative Pain, Acute
- Being tested
- Erector Spinae Plane Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
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.
Erector Spinae Plane BlockProcedure or surgery
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.
Erector Spinae Plane BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| (group B) | Active comparator | ultrasound (US)-guided ESPB using 20 ml bupivacaine 0.25% Receives: Procedure: Erector Spinae Plane Block |
| Group BS | Active comparator | 20 ml bupivacaine 0.25% with 8 mg dexamethasone Receives: Procedure: Erector Spinae Plane Block |
| Group BM | Active comparator | 20 ml bupivacaine 0.25% with dexmedetomidine 1mcg/kg Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration between the surgery end and the 1st rescue analgesia the patient requested.
Measured: 24 hours postoperatively
Secondary outcomes (2)
.Total ketorolac consumption
Measured: 24 hours postoperatively
. Number of patients needed rescue tramadol
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424599
- Sponsor's protocol ID
- HRM 3
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07424599
- Acronym / sponsor ID
- HRM 3
- Conditions
- Postoperative Pain, Acute
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| (group B) | Active comparator | Procedure: Erector Spinae Plane Blockultrasound (US)-guided ESPB using 20 ml bupivacaine 0.25% |
| Group BS | Active comparator | Procedure: Erector Spinae Plane Block20 ml bupivacaine 0.25% with 8 mg dexamethasone |
| Group BM | Active comparator | Procedure: Erector Spinae Plane Block20 ml bupivacaine 0.25% with dexmedetomidine 1mcg/kg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- myasthenic patients
- American Society of Anesthesiologists (ASA) physical grade of 2-3)
- who underwent video assisted thoracoscopic thymectomy
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plane BlockAn 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. | Procedure or surgery | (group B) |
| Erector Spinae Plane BlockAn 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. | Procedure or surgery | Group BS |
| Erector Spinae Plane BlockAn 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. | Procedure or surgery | Group BM |
Primary outcome
the duration between the surgery end and the 1st rescue analgesia the patient requested.
Time frame: 24 hours postoperatively
2 secondary outcomes
.Total ketorolac consumption
Time frame: 24 hours postoperatively
. Number of patients needed rescue tramadol
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block in people with Postoperative Pain, Acute, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ramy Mahrose (01281431097, Ramy.ahmed@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the duration between the surgery end and the 1st rescue analgesia the patient requested. (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.