Transversalis Fascia Plane Block Versus Surgical Wound Infiltration for Postoperative Analgesia in Open Inguinal Hernia Repair
NCT07238829
Agnosia, Hernia
View Trial DetailsNCT Number: NCT07238348
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Observational
This prospective observational clinical study investigates the comparative analgesic performance of three postoperative pain management strategies in patients undergoing video-assisted thoracoscopic surgery (VATS): Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Thoracic Epidural Analgesia (TEA), and systemic opioid analgesia. SPSIPB is a recently defined interfascial plane block that may provide multi-dermatomal analgesia of the upper thoracic region with a less invasive profile compared with traditional neuraxial techniques. TEA, although considered effective for thoracic surgery, is associated with technical difficulty and potential adverse effects such as hypotension, urinary retention, and motor block. Systemic opioid analgesia remains widely used but may be limited by nausea, sedation, and opioid-related complications.
In this study, adult patients scheduled for elective VATS under general anesthesia will be managed with one of the three analgesic strategies as part of routine clinical practice. No randomization or allocation will be performed by the investigators; analgesic technique selection will follow standard clinical decision-making by the treating anesthesiologist. Postoperative pain will be evaluated using the Numerical Rating Scale (NRS) at predefined time points, including 0, 1, 2, 6, 12, and 24 hours after surgery. Total opioid consumption within the first 24 hours will be quantified as the primary outcome, expressed in tramadol-equivalent dosing. Secondary outcomes include the requirement for rescue analgesics, postoperative nausea and vomiting, hemodynamic parameters, and the Quality of Recovery-15 (QoR-15) score.
The study aims to provide comparative clinical evidence on the analgesic efficacy and tolerability of SPSIPB relative to TEA and systemic opioid analgesia in minimally invasive thoracic surgery. By identifying potential advantages or limitations of each technique, the findings may support optimization of multimodal analgesia protocols, improve postoperative comfort, and contribute to enhanced recovery strategies in VATS patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 24 hours postoperatively
Total Opioid Consumption at 24 Hours
Time frame: 0, 1, 2, 6, 12, and 24 hours after surgery
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: First 24 hours postoperatively
Number of patients requiring additional analgesics despite standard postoperative analgesia.
Time frame: First 24 hours postoperatively
"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
Higher scores indicate more severe PONV. The presence of any nausea or vomiting and its severity will be recorded."
Time frame: Intraoperative and first 24 hours postoperative
"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: Preoperative baseline and 24 hours postoperative
"The quality of postoperative recovery will be evaluated using the Quality of Recovery-15 (QoR-15) questionnaire.
The QoR-15 is a validated patient-reported outcome measure with a score range from 0 to 150.
0 = poorest possible recovery
150 = best possible recovery
Higher scores indicate better postoperative recovery. Scores will be recorded preoperatively (baseline) and at 24 hours postoperatively."
Time frame: First 24 hours postoperatively
Time elapsed between arrival in the postoperative care unit and the first analgesic request via PCA.
Time frame: Intraoperative and first 24 hours postoperative
"Mean arterial pressure will be measured intraoperatively and during the first 24 postoperative hours. Mean arterial pressure is expressed in millimeters of mercury (mmHg). Higher or lower deviations from baseline may indicate hemodynamic instability."
Time frame: Intraoperative and first 24 hours postoperative
"Peripheral oxygen saturation (SpO₂) will be monitored intraoperatively and during the first 24 postoperative hours. SpO₂ is reported as a percentage (%), ranging from 0% to 100%, where higher values indicate better oxygenation."
Contact information is provided by the study sponsor or research team.
Karadeniz Technical University
Other
Prospective Evaluation of Analgesic Outcomes of Serratus Posterior Superior Intercostal Plane Block Versus Thoracic Epidural Analgesia and Systemic Opioid Analgesia After Video-Assisted Thoracoscopic Surgery
Acronym: SPSIPB-VATS
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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.
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