NCT07532681

Brief Summary

Video-assisted thoracoscopic surgery (VATS) is associated with significant postoperative pain despite lower morbidity compared with thoracotomy. Adequate pain management is essential within Enhanced Recovery After Surgery (ERAS) pathways to preserve respiratory function and facilitate postoperative recovery. Surgical intercostal block performed under direct vision is a simple and effective regional analgesic technique commonly used following VATS. However, the optimal timing of intercostal block administration during surgery remains uncertain. This prospective randomized double-blind study will compare surgical intercostal block performed at the beginning versus the end of the surgical procedure. The study aims to evaluate the effect of block timing on postoperative pain intensity and postoperative opioid consumption. The results may help optimize multimodal analgesic strategies in patients undergoing thoracic surgery.

Trial Health

63
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Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Apr 2026

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 Progress3%
Apr 2026Sep 2027

Study Start

First participant enrolled

April 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

April 2, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

VATSIntercostal Nerve BlockPain

Outcome Measures

Primary Outcomes (4)

  • Postoperative pain intensity during the first 24 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)

    Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), a patient-reported pain scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity.

    At 24 hours postoperatively

  • Postoperative pain intensity during the first hour following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)

    Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), a patient-reported pain scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity.

    At 1 hour postoperatively

  • Postoperative pain intensity during the first 6 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)

    Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), a patient-reported pain scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity.

    At 6 hours postoperatively

  • Postoperative pain intensity during the first 12 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)

    Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), a patient-reported pain scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity.

    At 12 hours postoperatively

Secondary Outcomes (7)

  • Postoperative pain intensity during the first 48 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)

    At 48 hours postoperatively

  • Postoperative pain intensity during the first 72 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)

    At 72 hours postoperatively

  • incidence of chronic postoperative pain 3 months after video-assisted thoracoscopic surgery (VATS)

    At 3 months after surgery

  • Intraoperative blood pressure stability

    During video-assisted thoracic surgery

  • Intraoperative opioid consumption during video-assisted thoracoscopic surgery (VATS).

    From induction of anesthesia to the end of surgery

  • +2 more secondary outcomes

Study Arms (2)

ICNB before incision

EXPERIMENTAL
Procedure: Intercostal nerve block before (ropivacaine 0.375%)Procedure: ICNB after (physiological serum)

ICNB at the end of surgery

ACTIVE COMPARATOR
Procedure: Intercostal Nerve Bloc before (physiological serum)Procedure: ICNB after (ropivacaine 0.375%)

Interventions

All patients will receive two intercostal nerve blocks using the same injection volume and technique. Intercostal nerve blocks will be performed twice: before surgical incision and at the end of the procedure. In both study groups, one injection will contain ropivacaine 0.375% and the other will contain normal saline. In the interventional arm, the pre-incision intercostal nerve block will contain the local anesthetic, whereas the end-of-procedure intercostal nerve block will contain normal saline. In the comparator arm, the pre-incision intercostal nerve block will contain normal saline, whereas the end-of-procedure intercostal nerve block will contain the local anesthetic.

ICNB before incision

All patients will receive intercostal nerve blocks using the same local anesthetic (ropivacaine 0.375%). Intercostal nerve blocks will be performed twice: before surgical incision and at the end of the procedure. In the interventional arm, the pre-incision intercostal nerve block will contain the local anesthetic, whereas the end-of-procedure intercostal nerve block will contain normal saline. In the comparator arm, the pre-incision intercostal nerve block will contain normal saline, whereas the end-of-procedure intercostal nerve block will contain the local anesthetic.

ICNB at the end of surgery

All patients will receive intercostal nerve blocks using the same local anesthetic (ropivacaine 0.375%). Intercostal nerve blocks will be performed twice: before surgical incision and at the end of the procedure. In the interventional arm, the pre-incision intercostal nerve block will contain the local anesthetic, and the end-of-procedure intercostal nerve block will contain normal saline. In the comparator arm, the pre-incision intercostal nerve block will contain normal saline, and the end-of-procedure intercostal nerve block will contain the local anesthetic.

ICNB at the end of surgery

All patients will receive an intercostal nerve block using the same local anesthetic (ropivacaine 0.375%). ICNB will be performed twice: before surgical incision and at the end of the procedure. In the interventional arm, the ICNB before surgery will contain the local anesthetic, and the ICNB after surgery will contain normal saline. In the comparator arm, the ICNB before surgery will contain normal saline, and the ICNB after surgery will contain the local anesthetic.

ICNB before incision

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • Scheduled for single-port or two-port video-assisted thoracoscopic surgery (VATS).
  • ASA classification 1 to 3
  • Able to understand the study, describe their pain and provide valid informed consent

You may not qualify if:

  • Neurological or psychiatric conditions that compromise the reliable assessment of pain(dementia, cognitive impairment, severe communication disorders)
  • Chronic opioid use or regular use (\> 3 months) of strong analgesics for chronic pain
  • History of allergy or known hypersensitivity to local anaesthetics
  • Coagulopathy or anticoagulant therapy precluding the safe performance of an intercostal block
  • Local infection at the injection site or active systemic infection
  • Bilateral thoracic surgery or intraoperative conversion to thoracotomy
  • Second surgery at the same site.
  • Current pregnancy or breastfeeding
  • Inability to understand postoperative instructions or a language barrier preventing a validated assessment of pain
  • Simultaneous participation in another clinical trial involving analgesia or thoracic surgery
  • Refusal to participate or withdrawal of consent at any time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HUB Erasme

Brussels, Belgium

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 16, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations