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

Phase 4

Not yet recruiting

• Conditions: Continuous Erector Spinae Plane Block; Unilateral Thoracotomy
• Interventions: Procedure: Continuous Erector Spinae Plane Block; Drug: Multimodal Intravenous Analgesia

• Registration Number: NCT06750627
• Lead Sponsor: Udayana University

Brief 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).

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-08
• Study First Submitted QC: 2024-12-19
• Study First Posted: 2024-12-27
• Last Update Submitted: 2024-12-28
• Last Update Posted: 2024-12-31
• Study Start: 2025-01-01
• Primary Completion: 2025-03-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Erector Spinae Plane Block	Continuous Erector Spinae Plane Block	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.
Multimodal Intravenous Analgesia	Multimodal Intravenous Analgesia	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.

Primary Outcome Measures

Name	Time	Method
Resting Pain Score 24 hours	24 hours	Pain scores are recorded after 24 hours after the operation using the Visual Analogue Scale (VAS). Patients are given a scale from 0 (no pain) to 10 (worst imaginable pain). Score are measured in continuous number, and higher number represents more pain.
Resting Pain Score 48 hours	48 hours	Pain scores are recorded after 48 hours after the operation using the Visual Analogue Scale (VAS). Patients are given a scale from 0 (no pain) to 10 (worst imaginable pain). Score are measured in continuous number, and higher number represents more pain.
Coughing Pain Score 24 hours	24 hours	Coughing pain scores are recorded by asking patient to cough and evaluate their pain. Pain scores are recorded after 24 hours after the operation using the Visual Analogue Scale (VAS). Patients are given a scale from 0 (no pain) to 10 (worst imaginable pain). Score are measured in continuous number, and higher number represents more pain.
Coughing Pain Score 48 hours	48 hours	Coughing pain scores are recorded by asking patient to cough and evaluate their pain. Pain scores are recorded after 48 hours after the operation using the Visual Analogue Scale (VAS). Patients are given a scale from 0 (no pain) to 10 (worst imaginable pain). Score are measured in continuous number, and higher number represents more pain.

Secondary Outcome Measures

Name	Time	Method
Time to First Analgesia	48 hours	First Time to Analgesia is the time recorded since patient went out from the Recovery Room to the time the patient first pressed the demand button on the Patient Controlled Analgesia device. The time will be recorded in hours.
Opioid Consumption 24 hours	24 hours	Opioid consumption is the total dose that is needed by the patient during a designated time frame to achieve or maintain adequate analgesic. This will be recorded after 24 hours and 48 hours after the surgery from the Patient Controlled Analgesia device and will be expressed in Mg Morphine Equivalent (MME)
Opioid Consumption 48 hours	48 hours	Opioid consumption is the total dose that is needed by the patient during a designated time frame to achieve or maintain adequate analgesic. This will be recorded after 24 hours and 48 hours after the surgery from the Patient Controlled Analgesia device and will be expressed in Mg Morphine Equivalent (MME)
Quality of Recovery Preoperative	At enrollment	Quality of Recovery is measured using the Quality of Recovery 15 (QoR-15) Questionnaire which evaluate the condition and experience of the patients. This data will be expressed in quantitative minimum score of 0 and maximum score of 150. Greater score means better outcome. The questionnaire will be given before the surgery.
Quality of Recovery 24 hours	24 hours	Quality of Recovery is measured using the Quality of Recovery 15 (QoR-15) Questionnaire which evaluate the condition and experience of the patients. This data will be expressed in quantitative minimum score of 0 and maximum score of 150. Greater score means better outcome. This questionnaire will be given 24 hours after the surgery
Quality of Recovery 48 hours	48 hours	Quality of Recovery is measured using the Quality of Recovery 15 (QoR-15) Questionnaire which evaluate the condition and experience of the patients. This data will be expressed in quantitative minimum score of 0 and maximum score of 150. Greater score means better outcome. The questionnaire will be given 48 hours after the surgery

Trial Locations

Locations (1)

RSUP Prof. dr. I.G.N.G. Ngoerah; 🇮🇩 Denpasar, Bali, Indonesia