Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:23 AM
Study NCT ID:
NCT07441161
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Erector Spinae Plane Block in Major Video-assisted Thoracic Surgery Compared to Intrathecal Morphine and Intercostal Nerve Block.
Sponsor:
Hospital Donostia
Organization:
Study Overview
Official Title:
Efficacy of Erector Spinae Plane Block in Major Video-assisted Thoracic Surgery Compared to Intrathecal Morphine and Intercostal Nerve Block: An Ambispective Observational Study
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AESPVIMVIB
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023-GON-ESB-01 | OTHER | HDonostia | View |