Effect of Early Versus Late Surgical Intercostal Block on Postoperative Pain Relief Following Video-Assisted Thoracic Surgery (VATS)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasme University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intercostal nerve block before (ropivacaine 0.375%)

    Procedure/Surgery

    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.

  • Intercostal Nerve Bloc before (physiological serum)

    Procedure/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, 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 after (ropivacaine 0.375%)

    Procedure/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 after (physiological serum)

    Procedure/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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: ICNB before incisionExperimental treatment 2 interventions
Group B: ICNB at the end of surgeryActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At 24 hours postoperatively
2

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.

Time frame
At 1 hour postoperatively
3

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.

Time frame
At 6 hours postoperatively
4

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.

Time frame
At 12 hours postoperatively

Secondary outcomes

1

Postoperative pain intensity during the first 48 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 intensit

Time frame
At 48 hours postoperatively
2

Postoperative pain intensity during the first 72 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 intensit

Time frame
At 72 hours postoperatively
3

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

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.

Time frame
At 3 months after surgery
4

Intraoperative blood pressure stability

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.

Time frame
During video-assisted thoracic surgery

Other outcomes

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