NCT07441161

Brief Summary

An ambispective observational study based on two groups (ITM and ICNB) from an earlier clinical trial conducted by our team(15) and a third group (ESPB) that received the new type of block, as we sought to assess the efficacy of this procedure and compare results with the other groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

February 16, 2026

Last Update Submit

February 23, 2026

Conditions

Video Assisted Thoracic Surgery (VATS)Erector Spinae Plane BlockRegional AnaesthesiaERAS Programmes

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain and dose of intravenous rescue morphine

    Postoperatively, we assessed the Numeric rating scale (NRS, values between 0 (less pain) and 10 (worst pain) score on arrival at the Postoperative care unit (PACU) (0 hours) and at 6, 12, 24, and 48 hours after arrival, and the dose of intravenous rescue morphine used.

    0,6,12,24, 48 hours

Study Arms (3)

ESPB group

patients undergoing major VATS with ESPB

Other: regional block

ITM group

patients undergoing major VATS with ITM

Other: Spinal analgesia

ICNB group

patients undergoing major VATS with ICNB

Other: regional block

Interventions

Spinal analgesiaOTHER

Intrathecal morphine

ITM group
regional blockOTHER

erector spinae plane block

ESPB group

Eligibility Criteria

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

18 years of age, were undergoing major lung resection by VATS

You may qualify if:

  • years of age, were undergoing major lung resection by VATS, and received ESPB at Donostia University Hospital between January 2023 and February 2024.

You may not qualify if:

  • A lack of written informed consent, a history of drug abuse, long-term treatment with opioids, and contraindications to the block, as well as unexpected conversion to open surgery (thoracotomy) or minor surgery (wedge resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Serrano Anguita 1, 7º

Donostia / San Sebastian, Gipuzkoa, 20008, Spain

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd, Head of the Anesthesiology and Critical Care Section

Study Record Dates

First Submitted

February 16, 2026

First Posted

February 27, 2026

Study Start

January 9, 2023

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

ES(1)