Analgesic Effectiveness of SPSIPB Versus Thoracic Epidural and Systemic Opioid Analgesia After VATS (SPSIPB-VATS)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorKaradeniz Technical University

About this trial

This prospective observational study aims to compare the postoperative analgesic effectiveness of three commonly used pain management strategies in video-assisted thoracoscopic surgery (VATS): Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Thoracic Epidural Analgesia (TEA), and systemic opioid analgesia. The study evaluates postoperative pain scores, opioid consumption, and the need for rescue analgesics within the first 24 hours after surgery. By analyzing analgesic performance and safety profiles of these techniques, the study seeks to provide evidence to guide optimal postoperative pain management for patients undergoing minimally invasive thoracic procedures.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18-75 years

Scheduled for elective video-assisted thoracoscopic surgery (VATS)

ASA physical status I-III

Ability to understand study procedures and provide written informed consent

Disqualifiers

Known allergy or contraindication to local anesthetics or study medications

Coagulopathy or use of anticoagulants not suitable for regional anesthesia

Local infection or skin lesions at the injection site

Severe pulmonary disease (e.g., severe COPD, uncontrolled asthma)

Trial population

Adult patients (18-75 years) undergoing elective video-assisted thoracoscopic surgery (VATS) under general anesthesia at a tertiary university hospital. Patients will receive SPSIPB, thoracic epidural analgesia, or systemic opioid analgesia as part of routine clinical practice, and will be followed for postoperative pain outcomes within the first 24 hours.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 3 trial groups
Group A: SPSIPB Group
Group B: Thoracic Epidural Analgesia (TEA) Group
Group C: Systemic Opioid Analgesia Group

Trial outcomes

Primary outcomes

1

Opioid Consumption

Total Opioid Consumption at 24 Hours

Time frame
24 hours postoperatively

Secondary outcomes

1

Pain Scores

Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain.

Time frame
0, 1, 2, 6, 12, and 24 hours after surgery
2

Need for Rescue Analgesia

Number of patients requiring additional analgesics despite standard postoperative analgesia.

Time frame
First 24 hours postoperatively
3

Incidence of Postoperative Nausea and Vomiting (PONV)

"PONV will be assessed using the Postoperative Nausea and Vomiting Intensity Scale (PONV Intensity Scale), which ranges from 0 to 3, where: 0 = No nausea or vomiting 1. = Mild nausea 2. = Moderate nausea or single episode of vomiting 3. = Severe nausea or two or more vomiting episodes Higher scores indicate more severe PONV. The presence of any nausea or vomiting and its severity will be recorded."

Time frame
First 24 hours postoperatively
4

Heart Rate (beats per minute)

"Heart rate will be recorded intraoperatively and during the first 24 postoperative hours. Heart rate is measured in beats per minute (bpm). Higher values indicate increased sympathetic activity or hemodynamic stress."

Time frame
Intraoperative and first 24 hours postoperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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