NCT07021131

Brief Summary

Analgesia related to the administration of local anesthetic solution into the fascia of erector spinae muscle is mediated by the effect of local anesthetic on the posterior and lateral branches of the anterior part of the spinal nerve. Comparable analgesic efficiency after the administration of both nerve blocks would reject the widespread theory of the paravertebral site of effect of the local anesthetic in ESPB.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Jul 2025Jul 2026

First Submitted

Initial submission to the registry

May 19, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

May 19, 2025

Last Update Submit

June 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cumulative opioid dose in 72 hours

    Irrespective of the type of the block, 20 mls of 0.25 % bupivacaine will be administered to the block catether every 8 hours. Every patients will receive non-opioid analgesics according to standardized ward guideline. VAS score is recorded at least every 3 hours (except for time patient is asleep). Any time patient reports VAS score \>=5, he/she will receive 5 mg of morphine intravenously (or equivalent dose of Oxycodone per os). Cumulative dose of opioids will be recorded.

    from end of surgery to 72 hours after the end surgery

Study Arms (2)

Erector spinae plane block

NO INTERVENTION

Patients undergoing VATS with the use of continuous peripheral nerve block type A.

Serratus Posterior Plane Block

EXPERIMENTAL

Patients undergoing general anaesthesia with continuous peripheral block type B.

Procedure: new type of peripheral block Serratus Posterior Plane Block

Interventions

Intervention will be Serratus Posterior Plane Block.

Serratus Posterior Plane Block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patiens undergoing VATS-surgery

You may not qualify if:

  • Age \< 20 years
  • Body Mass Index \>35 kg/m2
  • Technical difficulties with the nerve block administration and/or subsequent bolus application
  • Abnormal course of the surgery (e.g. conversion to thoracotomy) or the postoperative phase (e.g. surgical revision of the chest)
  • Patient's refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z.

Ústí nad Labem, Ústecký kraj, 40011, Czechia

Location

Study Officials

  • Miroslava Korfova

    Krajská zdravotní, a.s. - Masarykova nemocnice v Ústí nad Labem, o.z.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior researcher

Study Record Dates

First Submitted

May 19, 2025

First Posted

June 13, 2025

Study Start

July 1, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

June 13, 2025

Record last verified: 2025-06

Locations