Effect of Early Versus Late Surgical Intercostal Block on Postoperative Pain Relief Following Video-Assisted Thoracic Surgery (VATS): a Randomised, Double-blind Study
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Erasme University Hospital
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Postoperative pain intensity during the first 24 hours following video-assisted thoracoscopic surgery (VATS) using the Visual Analog Scale (VAS)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
ICNB before incision
Intervention: Intercostal nerve block before (ropivacaine 0.375%) (Procedure)
ICNB before incision
Intervention: ICNB after (physiological serum) (Procedure)
ICNB at the end of surgery
Intervention: Intercostal Nerve Bloc before (physiological serum) (Procedure)
ICNB at the end of surgery
Intervention: ICNB after (ropivacaine 0.375%) (Procedure)
Outcomes
Primary Outcomes
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
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.
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
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.
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
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.
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
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.
Secondary Outcomes
- Incidence of postoperative complications during hospitalization.(During hospitalization, up to 30 days)
- 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)
- Incidence of adverse effects and complications related to intercostal block administration.(From intercostal block administration until hospital discharge, up to 30 days)
Investigators
Céline Boudart
MD PhD
Erasme University Hospital