HUB Erasme
Brussels, Belgium
NCT Number: NCT07532681
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 opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Brussels, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
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.
Time frame: At 24 hours postoperatively
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
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
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
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 48 hours postoperatively
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
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 3 months after surgery
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: During video-assisted thoracic surgery
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: From induction of anesthesia to the end of surgery
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.
Time frame: During hospitalization, up to 30 days
Postoperative complications occurring during hospitalization will be recorded and categorized according to the Clavien-Dindo classification. Higher grades correspond to more severe postoperative complications.
Time frame: From intercostal block administration until hospital discharge, up to 30 days
Adverse effects and complications related to intercostal block administration occurring during surgery and hospitalization will be recorded.
Contact information is provided by the study sponsor or research team.
Erasme University Hospital
Other
Effect of Early Versus Late Surgical Intercostal Block on Postoperative Pain Relief Following Video-Assisted Thoracic Surgery (VATS): a Randomised, Double-blind Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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