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

Udayana University

Status and phase: Not yet enrolling; Phase 4

Conditions: Unilateral Thoracotomy; Continuous Erector Spinae Plane Block

Treatments: Drug: Multimodal Intravenous Analgesia; Procedure: Continuous Erector Spinae Plane Block

Study type: Interventional

Funder types: Other

Identifiers

NCT06750627

2708/UN14.2.2.VII.14/LT/2024

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of 21-65 years of age
• Undergoing Unilateral Thoracotomy Operation

Exclusion criteria

• Patients with ASA Physical Status > III
• Obese or Underweight Patients with BMI of less than 18.5 or more than 29.99
• Patients with contraindications to be given local anesthesia drugs
• Patients with contraindications to be given opioid drugs
• Patients refused to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Continuous Erector Spinae Plane Block

Active Comparator group

Description:

Participants will: * Undergo routine pain assessments, and recovery evaluations using tools using the Visual Analogue Scale (VAS) and Quality of Recovery-15 (QoR-15). * Receive continuous ESPB for analgesia with USG guidance after the surgery. * Receive Morphine Patient Controlled Analgesia + NSAIDs + Paracetamol * NSAIDs used is ketorolac, with dose of 30 mg every 8 hours * Paracetamol 1000 mg every 8 hours will be given * The PCA settings will include 30 mg of morphine diluted to 30 ml, a bolus dose of 1 ml, a lockout time of 6 minutes, 10 mg maximum dose/ 4 hours * Participate in follow-up visits for data collection on pain, opioid usage, and recovery quality.

Treatment:

Procedure: Continuous Erector Spinae Plane Block

Multimodal Intravenous Analgesia

Active Comparator group

Description:

Participants will: * Undergo routine pain assessments, and recovery evaluations using tools using the Visual Analogue Scale (VAS) and Quality of Recovery-15 (QoR-15). * Receive Morphine Patient Controlled Analgesia + NSAIDs + Paracetamol * NSAIDs used will be ketorolac of 30 mg every 8 hours * Paracetamol 1g every 8 hours will be given * The PCA settings will include 30 mg of morphine diluted to 30 ml, a bolus dose of 1 ml, a lockout time of 6 minutes, 10 mg maximum dose/ 4 hours. * Participate in follow-up visits for data collection on pain, opioid usage, and recovery quality.

Treatment:

Drug: Multimodal Intravenous Analgesia