NCT04400721

Efficacy of an Erector Spinae Plane Block in VATS/RATS

The Effects of Thoracic Nerve Blocks on Postoperative Pain, Respiratory Function and Recovery in Patients Undergoing Thoracoscopic Surgery

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This study aims to study the analgesic and respiratory effects of the erector spinae plane block for patients undergoing video-assisted thoracic surgery (VATS) or robotic assisted thoracic surgery (RATS).

Detailed description

A total of 120 subjects will be randomized into three groups (30 per group). Arm A: IV PCIA Arm B: IV PCIA + ultrasound guided Erector spinae block (ESPB, Single shot of 30ml of 0.5% solution of Naropin \[Ropivacaine\]) Arm C: IV PCIA + multilevel intra-thoracic intercostal nerve block (ICB, Single shot of 30ml of 0.5% solution of Naropin \[Ropivacaine\]) PCIA pumps for all study cohorts will be programmed according to our institution's standard protocol (Dipidolor \[Piritramide\] bolus: 2mg, interval: 7 min, max 4h dose: 30mg). The erector spinae block will be placed preoperatively, the intercostal block will be placed at the beginning of the procedure. All patients will receive standard postoperative care. The patients will be blinded for the study arm. The primary endpoint of this study is postoperative pain and will be recorded by using the numerical rating scale (NRS) pain score. Pain scores will be measured by the investigator at rest and during coughing. Opioid consumption will be monitored and registered for.

Conditions

• Pain, Postoperative
• Post-Op Complication

Interventions

Type	Name	Description
DRUG	Erector spinae plane block with ropivacaine 3.75mg/ml	Single shot erector spinae block

Timeline

• Start date: 2020-07-01
• Primary completion: 2022-06-28
• Completion: 2023-02-01
• First posted: 2020-05-22
• Last updated: 2020-05-28

Regulatory

• FDA-regulated drug study