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Clinical Trials/NCT07021651
NCT07021651Not yet recruitingNot Applicable

A Two-Center Randomized Controlled Trial

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital1 site in 1 country60 target enrollmentStarted: July 10, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Numeric Rating Scale

Study Overview

Brief Summary

The primary aim of this study was to compare the postoperative analgesic efficacy of thoracic paravertebral block with erector spinae plane block, which we use in thoracotomy surgeries. Secondary aims were to compare these groups in terms of Riker Agitation-Sedation Scale (RASS) scores, postoperative complications, postoperative opioid consumption, and patient satisfaction.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Patients who will undergo thoracotomy and are between the ages of 18-65
  • •have American Society of Anesthesiologists (ASA) risk classification I-II will be included in the study.

Exclusion Criteria

  • •Patients who did not agree to participate in the study,
  • •had an infection in the application area,
  • •had coagulopathy,
  • •were morbidly obese (Body mass index (BMI)>35),
  • •had drug allergy,
  • •had chronic pain, long-term opioid use, psychiatric illness history, and required emergency surgery were excluded from the study.

Arms & Interventions

Erektor spina plan block

Active Comparator

The local anesthetic is injected into the fascial plane between the erector spinae muscle and the transverse processes of the vertebrae. This allows the anesthetic to spread cranially and caudally, affecting multiple spinal nerves

Intervention: Erector Spinae Plane (ESP) block admistring (Procedure)

Toracik paravertebral block

Active Comparator

The local anesthetic is injected into the paravertebral space, which is bordered by the vertebral bodies, intervertebral discs, parietal pleura, and superior costotransverse ligament. This space contains the spinal nerves, sympathetic chain, and intercostal vessels

Intervention: Thoracic Paravertebral Block administring (Procedure)

Outcomes

Primary Outcomes

Numeric Rating Scale

Time Frame: Post-operative 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours

They will be numbered from 1 to 10. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.

Secondary Outcomes

  • Riker Agitation and Sedation Scale(Immediately after extubation)
  • Patient satisfaction score:(Post-operative 30 minutes)
  • 24-hour Tramadol usage:(posoperative 24 hours)

Investigators

Sponsor
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hülya Tosun Söner

Anesthesiology and Reanimation Spesialist

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Study Sites (1)

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