Video Assisted Thoracic Surgery (VATS)AESPVIMVIBNCT07441161
Efficacy of Erector Spinae Plane Block in Major Video-assisted Thoracic Surgery Compared to Intrathecal Morphine and Intercostal Nerve Block.
An observational study of Video Assisted Thoracic Surgery (VATS) and Erector Spinae Plane Block, run by Hospital Donostia at 1 site in Spain.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Video Assisted Thoracic Surgery (VATS), Erector Spinae Plane Block, Regional Anaesthesia
- What is being tested?
- Spinal analgesia and regional block
- How many people
- 113 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jan 2023to 28 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18 years of age, were undergoing major lung resection by VATS
Who may be able to join
- 18 years of age, were undergoing major lung resection by VATS, and received ESPB at Donostia University Hospital between January 2023 and February 2024.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Video Assisted Thoracic Surgery (VATS), Erector Spinae Plane Block, Regional Anaesthesia, ERAS Programmes
- Being tested
- Spinal analgesia, regional block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal analgesiaOther
Intrathecal morphine
regional blockOther
erector spinae plane block
regional blockOther
intercostal block with levobupivacaine
| Study group | Role | What they receive |
|---|---|---|
| ESPB group | patients undergoing major VATS with ESPB Receives: Other: regional block | |
| ITM group | patients undergoing major VATS with ITM Receives: Other: Spinal analgesia | |
| ICNB group | patients undergoing major VATS with ICNB Receives: Other: regional block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0,6,12,24, 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start9 Jan 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video Assisted Thoracic Surgery (VATS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Donostia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia González Santos, Hospital Donostia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441161
- Sponsor's protocol ID
- GON-ESB-2022-01
- Other IDs
- 2023-GON-ESB-01
- Acronym
- AESPVIMVIB
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07441161
- Acronym / sponsor ID
- AESPVIMVIB / GON-ESB-2022-01
- Conditions
- Video Assisted Thoracic Surgery (VATS), Erector Spinae Plane Block, Regional Anaesthesia, ERAS Programmes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Hospital DonostiaUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ESPB group | – | Other: regional blockpatients undergoing major VATS with ESPB |
| ITM group | – | Other: Spinal analgesiapatients undergoing major VATS with ITM |
| ICNB group | – | Other: regional blockpatients undergoing major VATS with ICNB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 years of age, were undergoing major lung resection by VATS
Key inclusion criteria (1 listed)
- 18 years of age, were undergoing major lung resection by VATS, and received ESPB at Donostia University Hospital between January 2023 and February 2024.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal analgesiaIntrathecal morphine | Other | ITM group |
| regional blockerector spinae plane block | Other | ESPB group |
| regional blockintercostal block with levobupivacaine | Other | ICNB group |
Primary outcome
Postoperative pain and dose of intravenous rescue morphine
Time frame: 0,6,12,24, 48 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Video Assisted Thoracic Surgery (VATS) and Erector Spinae Plane Block, run by Hospital Donostia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain and dose of intravenous rescue morphine (time frame: 0,6,12,24, 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.