Efficacy of Continuous Erector Spinae Plane Block to Reduce Postoperative Pain in Patients Undergoing Unilateral Thoracotomy
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Udayana University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Resting Pain Score 24 hours
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Continuous Erector Spinae Plane Block (Procedure)
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.
Intervention: Multimodal Intravenous Analgesia (Drug)
Outcomes
Primary Outcomes
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.
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.
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.
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
- Time to First Analgesia(48 hours)
- Opioid Consumption 24 hours(24 hours)
- Opioid Consumption 48 hours(48 hours)
- Quality of Recovery Preoperative(At enrollment)
- Quality of Recovery 24 hours(24 hours)
- Quality of Recovery 48 hours(48 hours)
Investigators
Jancolin Yani
Medical Doctor
Udayana University