Comparison of the Analgesic Efficacy of Ultrasound-guided Transversus Abdominis Plane Block and Single-dose Epidural Block in Patients Undergoing Umbilical Hernia Surgery.
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Sakarya University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Visuel Analog Scale 6th hour
Overview
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Ultrasound-Guided Transversus Abdominis Plane Block (Other)
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.
Intervention: Single-Dose Epidural Anesthesia (Other)
Outcomes
Primary Outcomes
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
- 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)
Investigators
Burçin Alaçam, MD
Anesthesiology Specialist
Sakarya University