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Umbilical HerniaNCT07327463

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

An observational study of Umbilical Hernia and Postoperative Pain Management, run by Sakarya University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Ultrasound-Guided Transversus Abdominis Plane Block and Single-Dose Epidural Anesthesia
Type of treatment
Injection or infusion
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jan 2026to 20 Jun 2026
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study 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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Severe hepatic or renal disease
  • Pregnancy or lactation
  • Inability to cooperate with postoperative pain assessment or inability to use VAS
  • Emergency surgery

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Sakarya University-Anesthesiology and Reanimation Department

    Sakarya, Serdivan, 54100

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the detailed description

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.

Being tested
Ultrasound-Guided Transversus Abdominis Plane Block, Single-Dose Epidural Anesthesia
Keywords
Single-Dose Epidural Analgesia, Transversus Abdominis Plane Block, Postoperative Pain Management, Umbilical Hernia Surgery
Medical subject headings
Hernia, Umbilical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound-Guided Transversus Abdominis Plane BlockOther

    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 AnesthesiaOther

    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.

Study groups in NCT07327463
Study groupRoleWhat they receive
Group Transversus Abdominis Plane BlockPatients in this group will undergo umbilical hernia surgery under general anesthesia. Following completion of the surgical procedure, postoperative analgesia will be provided using an ultrasound-guided transversus abdominis plane (TAP) block, performed according to routine clinical practice. The TAP block will be administered by an experienced anesthesiologist using standard techniques and local anesthetic agents. No additional interventions or investigational medications will be applied as part of the study. Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS) at admission to and discharge from the post-anesthesia care unit, as well as at the 1st, 6th, 12th, and 24th postoperative hours. Rescue analgesia will be administered based on routine institutional protocols according to patient-reported pain scores.
Receives: Other: Ultrasound-Guided Transversus Abdominis Plane Block
Group Single Dose Epidural AnesthesiaPatients in this group will undergo umbilical hernia surgery under single-dose epidural anesthesia administered as part of routine clinical practice. The epidural technique will be performed by an experienced anesthesiologist using standard institutional protocols. The single-dose epidural injection will be used to provide both intraoperative anesthesia and postoperative analgesia. No additional interventions or investigational medications will be administered for the purpose of this study. Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS) at admission to and discharge from the post-anesthesia care unit, as well as at the 1st, 6th, 12th, and 24th postoperative hours. Rescue analgesic treatment will be provided according to routine postoperative pain management protocols based on patient-reported pain scores.
Receives: Other: Single-Dose Epidural Anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: postoperative 6th hour

Secondary outcomes (5)
  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.

    Measured: postoperative 30.minutes

  2. 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.

    Measured: postoperartive 1st hour

  3. 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.

    Measured: postoperative 2nd hour

  4. 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.

    Measured: postoperative 12th hour

  5. Visuel Analog Scale 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.

    Measured: postoperative 24th hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2026
  2. Study start15 Jan 2026
  3. Primary completion9 Mar 2026
  4. Study completion20 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07327463
Sponsor's protocol ID
SAU-ANE-BA-02
Status last verified
Dec 2025
First submitted
24 Dec 2025
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yadav U, Doneria D, Gupta V, Verma S. Ultrasound-Guided Transversus Abdominis Plane Block Versus Single-Shot Epidural Block for Postoperative Analgesia in Patients Undergoing Inguinal Hernia Surgery. Cureus. 2023 Jan 17;15(1):e33876. doi: 10.7759/cureus.33876. eCollection 2023 Jan.

    PubMed 36819433

Questions about this trial

What is this clinical trial studying?

An observational study of Umbilical Hernia and Postoperative Pain Management, run by Sakarya University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visuel Analog Scale 6th hour (time frame: postoperative 6th hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07327463, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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