Ultrasound-Guided Transversus Abdominis Plane Block Versus Epidural Block for Umbilical Hernia Analgesia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorSakarya University
About this trial
This observational study aims to compare the postoperative analgesic effectiveness of ultrasound-guided transversus abdominis plane (TAP) block and single-dose epidural anesthesia in patients undergoing umbilical hernia surgery. Pain intensity will be assessed using the Visual Analog Scale (VAS) at predefined postoperative time points. The study seeks to determine which analgesic approach provides superior pain control and patient satisfaction in the postoperative period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 to 65 years
Patients scheduled for elective umbilical hernia surgery
ASA physical status I or II
Patients who undergo surgery under either: Single-dose epidural anesthesia, or general anesthesia with postoperative ultrasound-guided transversus abdominis plane (TAP) block, as part of routine clinical practice
Disqualifiers
ASA physical status III or higher
Known allergy or contraindication to local anesthetic agents
Coagulopathy or ongoing anticoagulant/antiplatelet therapy contraindicating regional anesthesia
Infection at the site of epidural or TAP block application
Trial population
The study population consists of adult patients aged 18 to 65 years with American Society of Anesthesiologists (ASA) physical status I or II who are scheduled to undergo elective umbilical hernia surgery. Patients included in the study receive anesthesia and postoperative analgesia as part of routine clinical practice, either with single-dose epidural anesthesia or with general anesthesia followed by ultrasound-guided transversus abdominis plane (TAP) block. All patients are managed according to standard institutional surgical and anesthetic protocols. No additional interventions, medications, or procedures are performed for research purposes. Postoperative pain assessment is conducted using the Visual Analog Scale (VAS) during the postoperative period. The study population reflects real-world clinical practice in umbilical hernia surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ultrasound-Guided Transversus Abdominis Plane Block
Other interventionUltrasound-guided transversus abdominis plane (TAP) block is performed as part of routine postoperative analgesia following general anesthesia in patients undergoing umbilical hernia surgery. The procedure is administered by an experienced anesthesiologist using standard institutional practice. No additional procedures or medications are applied specifically for the purpose of this observational study.
Single-Dose Epidural Anesthesia
Other interventionSingle-dose epidural anesthesia is administered as part of routine clinical practice to provide intraoperative anesthesia and postoperative analgesia in patients undergoing umbilical hernia surgery. The technique is performed by an experienced anesthesiologist according to standard institutional protocols. No investigational interventions or study-specific modifications are implemented.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Group Transversus Abdominis Plane Block1 intervention
Group B: Group Single Dose Epidural Anesthesia1 intervention
Trial outcomes
Primary outcomes
1
Visuel Analog Scale 6th hour
Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS) at the 6th postoperative hour to compare the analgesic effectiveness of single-dose epidural anesthesia and ultrasound-guided transversus abdominis plane (TAP) block. The Visual Analog Scale (VAS) is used to assess pain intensity on a numeric scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Patients are asked to select the number that best represents their current level of pain at the time of assessment. Increasing scores reflect increasing pain severity, with values of 1-3 considered mild pain, 4-6 moderate pain, and 7-10 severe pain. The VAS is a simple, reliable, and sensitive tool for detecting changes in pain intensity over time and is widely used in clinical trials and postoperative pain assessment.
Time frame
postoperative 6th hourSecondary outcomes
1
Visuel Analog Scale 30.minutes
Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS) at the 30 minute after postoperative hour to compare the analgesic effectiveness of single-dose epidural anesthesia and ultrasound-guided transversus abdominis plane (TAP) block. The Visual Analog Scale (VAS) is used to assess pain intensity on a numeric scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Patients are asked to select the number that best represents their current level of pain at the time of assessment. Increasing scores reflect increasing pain severity, with values of 1-3 considered mild pain, 4-6 moderate pain, and 7-10 severe pain. The VAS is a simple, reliable, and sensitive tool for detecting changes in pain intensity over time and is widely used in clinical trials and postoperative pain assessment.
Time frame
postoperative 30.minutes2
Visuel Analog Scale 1st hour
Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS) at the 1st postoperative hour to compare the analgesic effectiveness of single-dose epidural anesthesia and ultrasound-guided transversus abdominis plane (TAP) block. The Visual Analog Scale (VAS) is used to assess pain intensity on a numeric scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Patients are asked to select the number that best represents their current level of pain at the time of assessment. Increasing scores reflect increasing pain severity, with values of 1-3 considered mild pain, 4-6 moderate pain, and 7-10 severe pain. The VAS is a simple, reliable, and sensitive tool for detecting changes in pain intensity over time and is widely used in clinical trials and postoperative pain assessment.
Time frame
postoperartive 1st hour3
Visuel Analog Scale 2nd hour
Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS) at the 2nd postoperative hour to compare the analgesic effectiveness of single-dose epidural anesthesia and ultrasound-guided transversus abdominis plane (TAP) block. The Visual Analog Scale (VAS) is used to assess pain intensity on a numeric scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Patients are asked to select the number that best represents their current level of pain at the time of assessment. Increasing scores reflect increasing pain severity, with values of 1-3 considered mild pain, 4-6 moderate pain, and 7-10 severe pain. The VAS is a simple, reliable, and sensitive tool for detecting changes in pain intensity over time and is widely used in clinical trials and postoperative pain assessment.
Time frame
postoperative 2nd hour4
Visuel Analog Scale 12th hour
Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS) at the 12th postoperative hour to compare the analgesic effectiveness of single-dose epidural anesthesia and ultrasound-guided transversus abdominis plane (TAP) block. The Visual Analog Scale (VAS) is used to assess pain intensity on a numeric scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Patients are asked to select the number that best represents their current level of pain at the time of assessment. Increasing scores reflect increasing pain severity, with values of 1-3 considered mild pain, 4-6 moderate pain, and 7-10 severe pain. The VAS is a simple, reliable, and sensitive tool for detecting changes in pain intensity over time and is widely used in clinical trials and postoperative pain assessment.
Time frame
postoperative 12th hourSponsors and contacts
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Source ClinicalTrials.gov