NCT07327463

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2026

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

March 10, 2026

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

December 24, 2025

Last Update Submit

March 9, 2026

Conditions

Keywords

Single-Dose Epidural AnalgesiaTransversus Abdominis Plane BlockPostoperative Pain ManagementUmbilical Hernia Surgery

Outcome Measures

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.

    postoperative 6th hour

Secondary Outcomes (5)

  • Visuel Analog Scale 30.minutes

    postoperative 30.minutes

  • Visuel Analog Scale 1st hour

    postoperartive 1st hour

  • Visuel Analog Scale 2nd hour

    postoperative 2nd hour

  • Visuel Analog Scale 12th hour

    postoperative 12th hour

  • Visuel Analog Scale 24th hour

    postoperative 24th hour

Study Arms (2)

Group Transversus Abdominis Plane Block

Patients 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.

Other: Ultrasound-Guided Transversus Abdominis Plane Block

Group Single Dose Epidural Anesthesia

Patients 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.

Other: Single-Dose Epidural Anesthesia

Interventions

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.

Group Single Dose Epidural Anesthesia

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.

Group Transversus Abdominis Plane Block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University-Anesthesiology and Reanimation Department

Sakarya, Serdivan, 54100, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hernia, Umbilical

Interventions

Anesthesia, Epidural

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, VentralHernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology Specialist

Study Record Dates

First Submitted

December 24, 2025

First Posted

January 8, 2026

Study Start

January 15, 2026

Primary Completion

March 9, 2026

Study Completion

March 15, 2026

Last Updated

March 10, 2026

Record last verified: 2025-12

Locations