CClinicalTrials.gg
CompletedNCT07441161AESPVIMVIBUpdated Feb 27, 2026

Efficacy of Erector Spinae Plane Block in Major Video-assisted Thoracic Surgery Compared to Intrathecal Morphine and Intercostal Nerve Block.

An observational study in Video Assisted Thoracic Surgery (VATS), Erector Spinae Plane Block and Regional Anaesthesia, sponsored by Hospital Donostia. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Hospital Donostia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
113
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Introduction Thoracic surgery remains associated with a high incidence of moderate-to-severe acute postoperative pain despite minimally invasive approaches. However, a regional analgesic technique of choice for video-assisted thoracoscopic surgery (VATS) has not yet been established.

The literature describes several regional techniques. The objective of this study was to assess the efficacy and safety of ESPB compared to ITM and ICNB up to 48 hours after surgery.

Materials and methods An ambispective observational study of patients undergoing major VATS was carried out based on two groups (ITM, n=9; ICNB, n=90) from an earlier clinical trial conducted by our team, and a third group (ESPB, n=113) recruited prospectively at a later stage.

Pain was assessed at rest and on coughing on arrival at the post-anaesthesia care unit (PACU) and at 6, 12, 24, and 48 hours after surgery. Further, doses of rescue intravenous morphine, and adverse effects were recorded.

Statistical analysis For pain both at rest and on coughing, a two-way repeated measures analysis of variance was used to compare the mean differences between groups (treatment type) and assess interactions between group and time (pain at five time points). The Bonferroni correction was applied for post-hoc comparisons.

02

Conditions studied

  • Video Assisted Thoracic Surgery (VATS)
  • Erector Spinae Plane Block
  • Regional Anaesthesia
  • ERAS Programmes
03

In context

Lead sponsor

Hospital Donostia is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
113 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherSpinal analgesia

    Intrathecal morphine

  • Otherregional block

    erector spinae plane block

  • Otherregional block

    intercostal block with levobupivacaine

06

What researchers measure

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.

    Time frame: 0,6,12,24, 48 hours

07

Study locations

1 site
  • Serrano Anguita 1, 7º
    Donostia / San Sebastian, Gipuzkoa 20008, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07441161
Lead sponsor
Hospital Donostia
Responsible party
Silvia González Santos (Phd, Head of the Anesthesiology and Critical Care Section, Hospital Donostia) — Principal investigator
First posted
Feb 27, 2026
Start date
Jan 9, 2023
Primary completion
Feb 28, 2024
Completion
Feb 28, 2024
Last update
Feb 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion