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

NCT06750627 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-31

No results posted yet for this study

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.

Conditions

  • Continuous Erector Spinae Plane Block
  • Unilateral Thoracotomy

Interventions

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)

Sponsors & Collaborators

  • Udayana University

    lead OTHER

Principal Investigators

  • Tjokorda Gde Agung Senapathi, Professor · Udayana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-03-31
Completion
2025-05-31
FDA Drug
Yes

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06750627 on ClinicalTrials.gov