An observational study in Umbilical Hernia and Postoperative Pain Management, sponsored by Sakarya University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Sakarya University · Observational
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.
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.
67 studies on the registry are indexed under Hernia, Umbilical; 13 are open to participants now.
This study's enrollment of 30 is below the median of 118 across 25 observational studies indexed under Hernia, Umbilical.
Browse Hernia, Umbilical studies →Sakarya University is the lead sponsor of 190 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 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.
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 hour
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.minutes
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 hour
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 hour
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 hour
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.
Time frame: postoperative 24th hour
Ran from Jan 2026 to primary completion in Mar 2026, 1 month.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.