- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05847842
Comparison of Local Anesthetic Infiltration and Different Fascial Plane Blocks in Inguinal Hernia Repair
January 18, 2026 updated by: Gulay ERDOGAN KAYHAN, Eskisehir Osmangazi University
Comparison of the Effects of Local Anesthetic Infiltration and Different Fascial Plane Blocks on Postoperative Recovery Quality and Pain in Inguinal Hernia Repair
In this study, quadratus lumborum block (QLB), transversus abdominis plane (TAP) block, and local anesthetic infiltration will be performed preoperatively in patients who will undergo unilateral inguinal herniorrhaphy operation under general anesthesia.
Quality of recovery (QoR-15) score, postoperative acute and chronic pain levels will be evaluated.
Study Overview
Status
Completed
Conditions
Detailed Description
Inguinal hernia repair, one of the most common operations, causes moderate to severe postoperative pain.
The postoperative pain delays patients' recovery and return to daily life, increases the rate of readmission to the hospital, and can lead to persistent postoperative pain.Procedure-specific postoperative pain management (PROSPECT) recommendations for optimal pain management have been recently updated.
Accordingly, in addition to preoperative or intraoperative paracetamol and nonsteroidal anti-inflammatory analgesics, local anesthetic infiltration and/or regional analgesia techniques (ilio-inguinal nerve blocks or TAP block) with rescue opioids are recommended.
Also, it has been reported that further research is needed on new regional techniques (other fascial plane blocks etc).It has been shown that QLB potentially results in extensive sensory blockade (T7-12), and in cadaver studies, the iliohypogastric and ilioinguinal nerves are constantly involved.
In addition, there are studies suggesting that it provides much longer analgesia than TAP block.
There are few studies on its efficacy in inguinal hernia repair that are in pediatric cases or performed in addition to central blocks.
It is hypothesized that QLB may provide better and longer analgesia, may increase the quality of recovery and reduce the development of resistant chronic pain, compared to other regional methods such as local infiltration or TAP block, that proven effectiveness.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Eskişehir, Turkey (Türkiye), 26040
- Eskisehir Osmangazi University Faculty of Medicine
-
Eskişehir, Turkey (Türkiye), 26040
- Eskisehir Osmangazi Universty
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients who will undergo elective unilateral inguinal herniorrhaphy under general anesthesia
- American Society of Anesthesiology (ASA) physical classification I-III
Exclusion Criteria:
- Patients who will undergo laparoscopic surgery
- Previous inguinal hernia repair surgery
- A history of opioid use or pain management
- Coagulopathy or anticoagulant use
- Patients who have difficulty communicating or who are not cooperative
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group Q
Anterior quadratus lumborum block
|
20 mL of 0.25% bupivacaine will be given
|
|
Active Comparator: Group T
Transversus abdominis plane block
|
20 mL of 0.25% bupivacaine will be given
|
|
Active Comparator: Group L
Local infiltration
|
20 mL of 0.25% bupivacaine will be given
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of recovery assessed by Quality of recovery scale (QoR-15)
Time Frame: Postoperative 24th hour.
|
The 15-item quality of recovery (QoR-15) scale is a questionnaire used to evaluate the postoperative recovery quality of patients in the early postoperative stages.
The QoR-15 score comprises 15 questions that assess 5 recovery domains, namely, physical comfort, physical independence, psychological support, emotional status, and pain.
Each question is scored from 0 to 10 (0 none of the time to 10 all of the time).
|
Postoperative 24th hour.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain assessed by Numerical Rating Scale (NRS)
Time Frame: At the 2nd, 6th, 12th, 24th and 36th hours
|
Postoperative pain levels during rest and movement (from supine to sitting position) will be evaluated by Numerical rating scale (0-no pain; 10-unbearable pain)
|
At the 2nd, 6th, 12th, 24th and 36th hours
|
|
Postoperative chronic pain assessed by Numerical Rating Scale (NRS)
Time Frame: Three months later the operation date
|
Patients will be called by phone and the presence of chronic pain will be questioned with the Numerical Rating Scale (0-no pain; 10-unbearable pain).
|
Three months later the operation date
|
|
Postoperative neuropathic pain assessed by Douleur neuropathic pain (DN4) scale.
Time Frame: Three months later the operation date
|
Patients will be called by phone and the presence of neuropathic pain pain will be questioned with the Douleur neuropathic pain (DN4) scale. The items of the DN4 are scored based on a yes (1 point) /no (0 points) answer. This leads to a score range of 0-10. |
Three months later the operation date
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gulay Erdogan Kayhan, Prof Dr, Eskisehir Osmangazi University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2023
Primary Completion (Actual)
May 1, 2025
Study Completion (Actual)
August 1, 2025
Study Registration Dates
First Submitted
April 18, 2023
First Submitted That Met QC Criteria
May 4, 2023
First Posted (Actual)
May 8, 2023
Study Record Updates
Last Update Posted (Actual)
January 21, 2026
Last Update Submitted That Met QC Criteria
January 18, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Anatomical
- Hernia
- Hernia, Abdominal
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Hernia, Inguinal
- Anesthesia and Analgesia
- Anesthesia, Conduction
- Anesthesia
- Anesthesia, Local
Other Study ID Numbers
- ESOGUhernia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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