NCT07694141

Brief Summary

Analgesic management in thoracic surgery presents a particular challenge for the anesthesiologist, given the intensity of postoperative pain associated with thoracotomy, a surgical procedure that can impact respiratory function and the patient's subsequent recovery. Epidural analgesia is the gold standard. When epidural catheter placement is not feasible, erector spinae plane block is a safe alternative. The ultrasound target is easily visualized, and the injection site is far from the neuraxis, pleura, and major vascular structures. Consequently, this block has been incorporated into standard clinical practice as a treatment option for patients with complex cases or as an alternative approach when epidural catheter placement is not feasible. The primary objective of this study is to assess the effectiveness of postoperative analgesia in patients undergoing elective thoracic surgery. Study Population Design A prospective observational follow-up study will be conducted. ASA I-III patients undergoing scheduled thoracic surgery between November 1 and December 31, 2025, will be included. Their analgesic management will be based on standard clinical practice.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Nov 2025Jan 2027

Study Start

First participant enrolled

November 15, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

1.1 years

First QC Date

July 3, 2026

Last Update Submit

July 16, 2026

Conditions

Postoperative Pain Management

Keywords

thoracic surgerypainepidural analgesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    To evaluate the postoperative analgesic effect in patients undergoing elective thoracic surgery according to the Visual Analogue Scale, from 0 to 10.

    24 postoperative hours

Secondary Outcomes (2)

  • Postoperative analgesics consumption

    24 postoperative hours.

  • Postoperative complications

    First postoperative week.

Study Arms (2)

Epidural analgesia

Patients whose analgesic management will be achieved through an epidural catheter.

Diagnostic Test: Postoperative pain through Visual analogue scaleDiagnostic Test: Postoperative complications

Erector spinae plane block

Patients whose analgesic management will be achieved through an erector spinae plane block

Diagnostic Test: Postoperative pain through Visual analogue scaleDiagnostic Test: Postoperative complications

Interventions

Postoperative pain through Visual analogue scaleDIAGNOSTIC_TEST

Postoperative pain will be assessed using the visual analog pain scale at 1, 3, 6, 24, and 48 hours postoperatively.

Epidural analgesiaErector spinae plane block
Postoperative complicationsDIAGNOSTIC_TEST

The patient's postoperative evolution will be assessed until hospital discharge, in order to define the appearance of postoperative complications classified according to Clavien-Dindo classification.

Epidural analgesiaErector spinae plane block

Eligibility Criteria

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

The study will include ASA I-III patients scheduled for thoracic surgery at the Doctor Negrín University Hospital of Gran Canaria

You may qualify if:

  • Patients undergoing thoracic surgery between July 1 and October 31, 2020.
  • Age over 18.
  • ASA I-III.
  • Signed informed consent

You may not qualify if:

  • ASA IV-V.
  • Chronic opioid treatment or treatment in the Chronic Pain Unit.
  • Intravenous drug abuse.
  • Local anesthetic allergy.
  • Language barrier, cognitive impairment, or inability to participate in clinical assessment during the study.
  • BMI \<18 or \>35 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas, 35002, Spain

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ángel Becerra, MD PhD

    Hospital Universitario de Gran Canaria Doctor Negrín

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ángel Becerra Bolaños, MD PhD

CONTACT

+34676229025angbecbol@gmail.com

Aurelio Rodríguez-Pérez, MD PhD

CONTACT

676229025arodperp@gobiernodecanarias.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 3, 2026

First Posted

July 9, 2026

Study Start

November 15, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

July 20, 2026

Record last verified: 2026-07

Locations

ES(1)