NCT06750627

Efficacy of Continuous Erector Spinae Plane Block to Reduce Postoperative Pain in Patients Undergoing Unilateral Thoracotomy

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Udayana University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if continuous Erector Spinae Plane Block (ESPB) reduces postoperative pain in patients undergoing unilateral thoracotomy. It will also evaluate the safety and effectiveness of continuous ESPB. The total participants needed will be 30 persons. The main questions it aims to answer are: * Does continuous ESPB lower the intensity of postoperative pain compared to multimodal intravenous analgesia? * Does continuous ESPB increase the time to first analgesic request? * Does continuous ESPB reduce the amount of intravenous opioids required in the first 48 hours after surgery? * Does continuous ESPB improve the overall recovery quality within 48 hours post-surgery? Participants will: * Receive continuous ESPB or multimodal intravenous analgesia after the surgery. * Undergo routine pain assessments, and recovery evaluations using tools like the Visual Analogue Scale (VAS) and Quality of Recovery-15 (QoR-15). * Participate in follow-up visits for data collection on pain, opioid usage, and recovery quality.

Detailed description

For the Continuous ESPB Group, patients will receive continuous ESPB, NSAIDs, Paracetamol, and Morphine using Patient Controlled Analgesia (PCA) with a demand only mode. For the Intravenous Opioid, patient will receive Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), Paracetamol, and Morphine using Patient Controlled Analgesia (PCA).

Conditions

• Continuous Erector Spinae Plane Block
• Unilateral Thoracotomy

Interventions

Type	Name	Description
PROCEDURE	Continuous Erector Spinae Plane Block	Catheter are placed between the erector spinae muscle and the transversus processus with ultrasound guidance, blocking the dorsal and ventral ramus from the thorax and abdominal spinal nerves, at the level of T5. Local anesthesia is injected. Drugs used are Bupivacaine 0.25% with volume of 25 ml.
DRUG	Multimodal Intravenous Analgesia	Multimodal intravenous analgesia refers to the use of multiple intravenous (IV) agents with different mechanisms of action to provide effective pain relief. The goal is to achieve synergistic effects that improve analgesia while minimizing the doses of individual drugs, thereby reducing side effects. This approach is often used in perioperative and acute pain management. Patient will receive combinations of opioid through Patient Controlled Analgesia (PCA) device, NSAIDs, and Paracetamol (Acetaminophen)

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-03-31
• Completion: 2025-05-31
• First posted: 2024-12-27
• Last updated: 2024-12-31

Locations

1 site across 1 country: Indonesia

Regulatory

• FDA-regulated drug study