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

December 28, 2024 updated by: Jancolin Yani, Udayana University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
    • Bali
      • Denpasar, Bali, Indonesia, 80113
        • RSUP Prof. dr. I.G.N.G. Ngoerah
        • Contact:
          • Bagian Pendidikan dan Penelitian RSUP Sanglah
          • Phone Number: +62361244548
          • Email: info@unud.ac.id
        • Contact:
        • Contact:
          • Jancolin Yani, Medical Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Other Names:
  • ESPB
Active Comparator: 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.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting Pain Score 24 hours
Time Frame: 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.
24 hours
Resting Pain Score 48 hours
Time Frame: 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.
48 hours
Coughing Pain Score 24 hours
Time Frame: 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.
24 hours
Coughing Pain Score 48 hours
Time Frame: 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.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Analgesia
Time Frame: 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.
48 hours
Opioid Consumption 24 hours
Time Frame: 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)
24 hours
Opioid Consumption 48 hours
Time Frame: 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)
48 hours
Quality of Recovery Preoperative
Time Frame: 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.
At enrollment
Quality of Recovery 24 hours
Time Frame: 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
24 hours
Quality of Recovery 48 hours
Time Frame: 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
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Udayana University

Investigators

  • Study Director: Tjokorda Gde Agung Senapathi, Professor, Udayana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

December 8, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 28, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2708/UN14.2.2.VII.14/LT/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data will be deidentified and maybe shared through the author's email after there are formal request through the principal investigator email. The request must contain the intentions for the use of the data (example: for Meta-Analysis purpose)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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