- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07532681
Effect of Early Versus Late Surgical Intercostal Block on Postoperative Pain Relief Following Video-Assisted Thoracic Surgery (VATS)
Effect of Early Versus Late Surgical Intercostal Block on Postoperative Pain Relief Following Video-Assisted Thoracic Surgery (VATS): a Randomised, Double-blind Study
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Celine Boudart
- Phone Number: +3225553919
- Email: celine.boudart@hubruxelles.be
Study Locations
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Brussels, Belgium
- HUB Erasme
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Contact:
- Celine Boudart
- Phone Number: +3225553919
- Email: celine.boudart@hubruxelles.be
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: ICNB before incision
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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.
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.
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Active Comparator: ICNB at the end of surgery
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative pain intensity during the first 24 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)
Time Frame: At 24 hours postoperatively
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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.
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At 24 hours postoperatively
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Postoperative pain intensity during the first hour following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)
Time Frame: At 1 hour postoperatively
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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.
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At 1 hour postoperatively
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Postoperative pain intensity during the first 6 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)
Time Frame: At 6 hours postoperatively
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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.
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At 6 hours postoperatively
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Postoperative pain intensity during the first 12 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)
Time Frame: At 12 hours postoperatively
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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.
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At 12 hours postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative pain intensity during the first 48 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)
Time Frame: At 48 hours postoperatively
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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 intensit
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At 48 hours postoperatively
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Postoperative pain intensity during the first 72 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)
Time Frame: At 72 hours postoperatively
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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 intensit
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At 72 hours postoperatively
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incidence of chronic postoperative pain 3 months after video-assisted thoracoscopic surgery (VATS)
Time Frame: At 3 months after surgery
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Chronic postoperative pain will be defined as pain developing after surgery and persisting for at least 3 months, not attributable to other causes and assessed by patient interview.
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At 3 months after surgery
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Intraoperative blood pressure stability
Time Frame: During video-assisted thoracic surgery
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Variations in blood pressure during the procedure and need for vasopressors or corrective interventions. Blood pressure will be measured in mm Hg using an arterial catheter. |
During video-assisted thoracic surgery
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Intraoperative opioid consumption during video-assisted thoracoscopic surgery (VATS).
Time Frame: From induction of anesthesia to the end of surgery
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Intraoperative opioid consumption will be defined as the total cumulative dose of opioids administered between induction of anesthesia and the end of surgery.
For remifentanil, consumption should be recorded as the total cumulative dose administered during the procedure.
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From induction of anesthesia to the end of surgery
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Incidence of postoperative complications during hospitalization.
Time Frame: During hospitalization, up to 30 days
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Postoperative complications occurring during hospitalization will be recorded and categorized according to the Clavien-Dindo classification.
Higher grades correspond to more severe postoperative complications.
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During hospitalization, up to 30 days
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Incidence of adverse effects and complications related to intercostal block administration.
Time Frame: From intercostal block administration until hospital discharge, up to 30 days
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Adverse effects and complications related to intercostal block administration occurring during surgery and hospitalization will be recorded.
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From intercostal block administration until hospital discharge, up to 30 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2026/145
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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