Clinical trial NCT06750627: Efficacy of Continuous Erector Spinae Plane Block to Reduce Postoperative Pain in Patients Undergoing Unilateral Thoracotomy
Official title: Efficacy of Continuous Erector Spinae Plane Block to Reduce Postoperative Pain in Patients Undergoing Unilateral Thoracotomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Continuous Erector Spinae Plane Block
Unilateral Thoracotomy
Keywords: Erector Spinae Plane Block
Unilateral Thoracotomy
Regional Anesthesia
Continuous Peripheral Nerve Block
Lead sponsor: Udayana University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Resting Pain Score 24 hours
timeFrame: 24 hours
measure: Resting Pain Score 48 hours
timeFrame: 48 hours
measure: Coughing Pain Score 24 hours
timeFrame: 24 hours
measure: Coughing Pain Score 48 hours
timeFrame: 48 hours
Secondary outcomes:
measure: Time to First Analgesia
timeFrame: 48 hours
measure: Opioid Consumption 24 hours
timeFrame: 24 hours
measure: Opioid Consumption 48 hours
timeFrame: 48 hours
measure: Quality of Recovery Preoperative
timeFrame: At enrollment
measure: Quality of Recovery 24 hours
timeFrame: 24 hours
measure: Quality of Recovery 48 hours
timeFrame: 48 hours
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: RSUP Prof. dr. I.G.N.G. Ngoerah
state: Bali
Study officials:
affiliation: Udayana University
name: Tjokorda Gde Agung Senapathi, Professor
role: STUDY_DIRECTOR
References:
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citation: Fawzi Hanna, M.E., Abdel Latif, S.A.M., Hussien Maamoon, R.M., Abdel-Mouty Taher, I.A.-A., 2024. Erector Spinae Plane Block for Postoperative Analgesia after Video-Assisted Thoracoscopic Surgery (VATS). QJM: An International Journal of Medicine 117, hcae070.062. https://doi.org/10.1093/qjmed/hcae070.062
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