Clinical Trials Directory

Trials / Completed

CompletedNCT07441161

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

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
Phase
Study type
Observational
Enrollment
113 (actual)
Sponsor
Hospital Donostia · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERSpinal analgesiaIntrathecal morphine
OTHERregional blockerector spinae plane block
OTHERregional blockintercostal block with levobupivacaine

Timeline

Start date
2023-01-09
Primary completion
2024-02-28
Completion
2024-02-28
First posted
2026-02-27
Last updated
2026-02-27

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT07441161. Inclusion in this directory is not an endorsement.