NCT07482449

Brief Summary

Effective control of severe post-thoracotomy pain is pivotal for minimizing pulmonary complications and enhancing patient comfort. This prospective, randomized, three-arm study compared the analgesic efficacy of ultrasound-guided bilateral erector spinae plane block (ESPB) and thoracic epidural analgesia (TEA) with conventional intravenous opioid-based care. Seventy-two ASA I-II patients aged 18-80 years undergoing elective thoracotomy were block-randomized to receive TEA, ESPB, or no regional intervention (control). All procedures were performed at the end of surgery before emergence from anesthesia. Pain intensity was assessed at 1, 2, 4, 6, 12, and 24 h postoperatively using the Visual Analog Scale (VAS). Additional outcomes included time to first rescue opioid, total tramadol consumption, time to modified Aldrete score (MAS) ≥ 9, patient satisfaction, and length of hospital stay.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 8, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2026

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 10, 2026

Last Update Submit

March 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison of the analgesic efficacy of regional techniques

    The analgesic efficacy of TEA and ESP blocks after thoracotomy surgeries was evaluated at 1, 2, 4, 6, 12, and 24 hours postoperatively in terms of VAS scores and analgesic drug consumption. The frequency and amount of tramadol and fentanyl analgesic drug consumption were recorded in the postoperative period. VAS scores were monitored at the specified times. The results were compared, and analgesic efficacy was evaluated. In addition, patient satisfaction (1: excellent, 2: good, 3: moderate, 4: poor), intensive care unit and hospital stay, and postoperative recovery time (using the modified aldarate score) were evaluated.

    THE FIRST 24 HOURS AFTER THORACOTOMY SURGERY

Study Arms (3)

TEA ANALGESİA

PATIENTS WHO UNDERWENT TEA AFTER THORACOTOMY CASES

TEA BLOCK

ATIENTS RECEIVING INTRAVENOUS ANALGESIA AFTER THORACOTOMY CASES

İV ANALGESİA

PATIENTS RECEIVING INTRAVENOUS ANALGESICS AFTER THORACOTOMY CASES

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who will undergo thoracotomy surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University Faculty of Medicine Hospital

Edirne, Merkez, 22020, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
research assistant doctor

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 19, 2026

Study Start

May 8, 2023

Primary Completion

May 20, 2025

Study Completion

February 12, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations