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NCT Number: NCT07327463

Ultrasound-Guided Transversus Abdominis Plane Block Versus Epidural Block for Umbilical Hernia Analgesia

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.

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Key information

Conditions

Umbilical Hernia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Abdominal Hernia, Umbilical Hernia, Ventral Infant, Newborn, Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Pain Management

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sakarya University-Anesthesiology and Reanimation Department

Sakarya, Serdivan, 54100, Turkey (Türkiye)

About this study

Postoperative pain management plays a critical role in reducing the adverse consequences of surgery, facilitating early mobilization, enhancing patient comfort, and promoting rapid recovery and discharge. Epidural analgesia is widely regarded as the gold standard for postoperative pain control due to its strong analgesic efficacy and its ability to reduce the need for additional anesthetic and analgesic agents. However, peripheral and fascial plane blocks such as the transversus abdominis plane (TAP) block have gained increasing popularity because of their opioid-sparing effects and favorable side-effect profiles.

The transversus abdominis plane is a neurofascial plane located between the internal oblique and transversus abdominis muscles and provides somatic analgesia to the anterolateral abdominal wall by blocking the thoracolumbar nerves from T9 to L1. Previous studies have demonstrated that TAP block is associated with reduced postoperative pain scores, decreased opioid consumption, and fewer opioid-related adverse effects.

This study is designed as an observational comparison of two routinely applied analgesic strategies in patients undergoing umbilical hernia surgery. Patients aged between 18 and 65 years, classified as American Society of Anesthesiologists (ASA) physical status I or II, will be included. Depending on the anesthesiologist's clinical judgment and routine practice, patients undergo surgery either under single-dose epidural anesthesia or under general anesthesia followed by postoperative ultrasound-guided TAP block for analgesia.

No additional interventions or medications will be administered for the purpose of this study. Data collection will begin once patients are admitted to the postoperative recovery unit. Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS) at recovery room admission and discharge, as well as at the 1st, 6th, 12th, and 24th postoperative hours. Rescue analgesia will be administered according to routine clinical protocols based on patients' reported pain levels.

The primary objective of this study is to compare the analgesic effectiveness of single-dose epidural anesthesia and TAP block in umbilical hernia surgery. Secondary objectives include the evaluation of patient satisfaction and the identification of the most effective postoperative analgesic approach within routine clinical practice. As all procedures involved are part of standard care, this study does not constitute an interventional drug trial but rather an observational assessment of established analgesic techniques.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Ability to understand and use the Visual Analog Scale (VAS)
  • Provision of written informed consent

Exclusion criteria

  • 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
  • History of chronic pain, long-term opioid use, or chronic analgesic consumption
  • Neurological disorders affecting pain perception or assessment
  • Severe hepatic or renal disease
  • Pregnancy or lactation
  • Inability to cooperate with postoperative pain assessment or inability to use VAS
  • Emergency surgery

Treatment and study plan

Ultrasound-Guided Transversus Abdominis Plane Block

Other

Ultrasound-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

Single-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.

Primary outcomes

  1. Visuel Analog Scale 6th hour

    Time frame: postoperative 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.

Secondary outcomes

  1. Visuel Analog Scale 30.minutes

    Time frame: postoperative 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.

  2. Visuel Analog Scale 1st hour

    Time frame: postoperartive 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.

  3. Visuel Analog Scale 2nd hour

    Time frame: postoperative 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.

  4. Visuel Analog Scale 12th hour

    Time frame: postoperative 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.

  5. Visuel Analog Scale 24th hour

    Time frame: postoperative 24th hour

    Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS) at the 24th 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.

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

Comparison of the Analgesic Efficacy of Ultrasound-guided Transversus Abdominis Plane Block and Single-dose Epidural Block in Patients Undergoing Umbilical Hernia Surgery.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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