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Not yet recruiting 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

No phase Interventional Postoperative Pain, Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Erector Spinae Plane Block, Erector Spinae Plane Block, Erector Spinae Plane Block.
Who it may be relevant to
Registry conditions: Postoperative Pain, Acute. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Procedure Erector Spinae Plane Block
    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traversing through trapezius, rhomboid, and erector spinae muscles till reaching the transverse process then slightly withdrawn and hydrodissection was done by 3 mL of saline 0.9% to verify the accurate implantation of the block needle tip between the erector spinae muscle and the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 observ
  • Procedure Erector Spinae Plane Block
    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 observ
  • Procedure Erector Spinae Plane Block
    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 observ

Primary outcome measures

  • the duration between the surgery end and the 1st rescue analgesia the patient requested. [Time frame: 24 hours postoperatively]
Secondary outcome measures (2)
  • .Total ketorolac consumption [Time frame: 24 hours postoperatively]
  • . Number of patients needed rescue tramadol [Time frame: 24 hours postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07424599 · HRM 3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗