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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21-65
SponsorUdayana University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients of 21-65 years of age

Undergoing Unilateral Thoracotomy Operation

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Continuous Erector Spinae Plane Block

    Procedure/Surgery

    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.

  • 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)

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Continuous Erector Spinae Plane BlockActive comparator 1 intervention
Group B: Multimodal Intravenous AnalgesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Resting Pain Score 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.

Time frame
24 hours
2

Resting Pain Score 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.

Time frame
48 hours
3

Coughing Pain Score 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.

Time frame
24 hours
4

Coughing Pain Score 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.

Time frame
48 hours

Secondary outcomes

1

Time to First Analgesia

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.

Time frame
48 hours
2

Opioid Consumption 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)

Time frame
24 hours
3

Opioid Consumption 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)

Time frame
48 hours
4

Quality of Recovery Preoperative

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.

Time frame
At enrollment

Other outcomes

Sponsors and contacts

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