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

Efficacy of Erector Spinae Plane Block in Major Video-assisted Thoracic Surgery Compared to Intrathecal Morphine and Intercostal Nerve Block: An Ambispective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Erector Spinae Plane Block; Regional Anaesthesia; Video Assisted Thoracic Surgery (VATS); ERAS Programmes
• Intervention / Treatment: Other: regional block; Other: regional block; Other: Spinal analgesia

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.

• Study Type: Observational
• Enrollment (Actual): 113

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ESPB group; patients undergoing major VATS with ESPB	Other: regional block; erector spinae plane block; Other: regional block; intercostal block with levobupivacaine
ITM group; patients undergoing major VATS with ITM	Other: Spinal analgesia; Intrathecal morphine
ICNB group; patients undergoing major VATS with ICNB	Other: regional block; erector spinae plane block; Other: regional block; intercostal block with levobupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospital Donostia

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: GON-ESB-2022-01; 2023-GON-ESB-01 (Other Identifier: HDonostia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No