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NCT Number: NCT06750627

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

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.

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Key information

Conditions

Continuous Erector Spinae Plane Block Unilateral Thoracotomy

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous erector spinae plane block

Procedure

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

Multimodal Intravenous Analgesia

Drug

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)

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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)

  3. 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)

  4. 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.

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jancolin Yani, Medical Doctor

CONTACT

[email protected]

+628128781619

Steven Okta Chandra, Medical Doctor

CONTACT

[email protected]

+6282148198699

Sponsors and collaborators

Lead sponsor

Udayana University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.