NCT07021651

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

July 10, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2025

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

10 days

First QC Date

June 4, 2025

Last Update Submit

June 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Numeric Rating Scale

    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.

    Post-operative 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours

Secondary Outcomes (3)

  • Riker Agitation and Sedation Scale

    Immediately after extubation

  • Patient satisfaction score:

    Post-operative 30 minutes

  • 24-hour Tramadol usage:

    posoperative 24 hours

Study Arms (2)

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

Procedure: Erector Spinae Plane (ESP) block admistring

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

Procedure: Thoracic Paravertebral Block administring

Interventions

In the ESPB group, the probe was placed longitudinally at the level of the T5 transverse process, 2-3 cm lateral from the midline. The muscles were visualized superior to the transverse process ; then, the needle was inserted in the craniocaudal direction using the in-plane technique. A dose of 2 mL normal saline were injected into the two layers of the interfacial area under the erector spinae muscle, and the proper injection site was confirmed. After visualizing the linear spread of saline in the fascial plane, 20 mL of 0.25% bupivacaine was injected there for the block.

Erektor spina plan block

In the TPVB group, the probe was placed 2-3 cm laterally and vertically of the T5 spinous process. Once the transverse process, corresponding paravertebral space, internal intercostal membrane, and pleura was identified , the needle was inserted in the lateromedial direction using the in-plane technique. After confirmation of pleural displacement with 2 mL saline, 20 mL of 0.25% bupivacaine was administered for the block.

Toracik paravertebral block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences University Gazi Yaşargil Training and Research Hospital

Kayapınar, Di̇yarbakir, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Parapsychology

Intervention Hierarchy (Ancestors)

Behavioral SciencesBehavioral Disciplines and Activities

Central Study Contacts

Hülya Tosun Söner, doktor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation Spesialist

Study Record Dates

First Submitted

June 4, 2025

First Posted

June 15, 2025

Study Start

July 10, 2025

Primary Completion

July 20, 2025

Study Completion

August 1, 2025

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations