Postoperative PainNCT05847842
Comparison of Local Anesthetic Infiltration and Different Fascial Plane Blocks in Inguinal Hernia Repair
A study testing Anterior quadratus lumborum block, Transversus abdominis plane block and Local infiltration in people with Postoperative Pain and Inguinal Hernia, run by Eskisehir Osmangazi University at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Pain, Inguinal Hernia, Local Infiltration
- What is being tested?
- Anterior quadratus lumborum block, Transversus abdominis plane block and Local infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 1 Aug 2025
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will undergo elective unilateral inguinal herniorrhaphy under general anesthesia
- American Society of Anesthesiology (ASA) physical classification I-III
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Eskisehir Osmangazi University Faculty of Medicine
Eskişehir, 26040
Eskisehir Osmangazi Universty
Eskişehir, 26040
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain, Inguinal Hernia, Local Infiltration, Quality of Recovery, Quadratus Lumborum Block, Transversus Abdominis Plane Block
- Being tested
- Anterior quadratus lumborum block, Transversus abdominis plane block, Local infiltration
- Medical subject headings
- Pain, Postoperative, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior quadratus lumborum blockProcedure or surgery
20 mL of 0.25% bupivacaine will be given
Transversus abdominis plane blockProcedure or surgery
20 mL of 0.25% bupivacaine will be given
Local infiltrationProcedure or surgery
20 mL of 0.25% bupivacaine will be given
| Study group | Role | What they receive |
|---|---|---|
| Group Q | Active comparator | Anterior quadratus lumborum block Receives: Procedure: Anterior quadratus lumborum block |
| Group T | Active comparator | Transversus abdominis plane block Receives: Procedure: Transversus abdominis plane block |
| Group L | Active comparator | Local infiltration Receives: Procedure: Local infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery assessed by Quality of recovery scale (QoR-15)
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).
Measured: Postoperative 24th hour.
Secondary outcomes (3)
Postoperative pain assessed by Numerical Rating Scale (NRS)
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)
Measured: At the 2nd, 6th, 12th, 24th and 36th hours
Postoperative chronic pain assessed by Numerical Rating Scale (NRS)
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).
Measured: Three months later the operation date
Postoperative neuropathic pain assessed by Douleur neuropathic pain (DN4) scale.
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.
Measured: Three months later the operation date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start1 Apr 2023
- Primary completion1 May 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulay ERDOGAN KAYHAN, Eskisehir Osmangazi University
- Investigators
- Gulay Erdogan Kayhan, Prof Dr, Principal investigator, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847842
- Sponsor's protocol ID
- ESOGUhernia
- Status last verified
- Jan 2026
- First submitted
- 18 Apr 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Okur O, Karaduman D, Tekgul ZT, Koroglu N, Yildirim M. Posterior quadratus lumborum versus transversus abdominis plane block for inguinal hernia repair: a prospective randomized controlled study. Braz J Anesthesiol. 2021 Sep-Oct;71(5):505-510. doi: 10.1016/j.bjane.2020.11.004. Epub 2021 Feb 10.
PubMed 34537121
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Local Anesthetic Infiltration and Different Fascial Plane Blocks on Postoperative Recovery Quality and Pain in Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT05847842
- Acronym / sponsor ID
- ESOGUhernia
- Conditions
- Postoperative Pain, Inguinal Hernia, Local Infiltration, Quality of Recovery, Quadratus Lumborum Block, Transversus Abdominis Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Q | Active comparator | Procedure: Anterior quadratus lumborum blockAnterior quadratus lumborum block |
| Group T | Active comparator | Procedure: Transversus abdominis plane blockTransversus abdominis plane block |
| Group L | Active comparator | Procedure: Local infiltrationLocal infiltration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who will undergo elective unilateral inguinal herniorrhaphy under general anesthesia
- American Society of Anesthesiology (ASA) physical classification I-III
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anterior quadratus lumborum block20 mL of 0.25% bupivacaine will be given | Procedure or surgery | Group Q |
| Transversus abdominis plane block20 mL of 0.25% bupivacaine will be given | Procedure or surgery | Group T |
| Local infiltration20 mL of 0.25% bupivacaine will be given | Procedure or surgery | Group L |
Primary outcome
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).
3 secondary outcomes
Postoperative pain assessed by Numerical Rating Scale (NRS)
Time frame: 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
Postoperative neuropathic pain assessed by Douleur neuropathic pain (DN4) scale.
Time frame: Three months later the operation date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 34537121Okur O, Karaduman D, Tekgul ZT, Koroglu N, Yildirim M. Posterior quadratus lumborum versus transversus abdominis plane block for inguinal hernia repair: a prospective randomized controlled study. Braz J Anesthesiol. 2021 Sep-Oct;71(5):505-510. doi: 10.1016/j.bjane.2020.11.004. Epub 2021 Feb 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulay Erdogan Kayhan, Prof Dr principal investigator
Eskisehir Osmangazi University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior quadratus lumborum block, Transversus abdominis plane block and Local infiltration in people with Postoperative Pain and Inguinal Hernia, run by Eskisehir Osmangazi University at 2 sites 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 2 inclusion and 5 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Quality of recovery assessed by Quality of recovery scale (QoR-15) (time frame: Postoperative 24th 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 NCT05847842, 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 21 Jan 2026.