İnguinal HerniaNCT07604259
Comparison of QLB and TFP Block for Postoperative Analgesia in Laparoscopic Inguinal Hernia
A study testing Lateral Quadratus Lumborum Block, Transversalis Fascia Plane Block and Port Site Infiltration in people with İnguinal Hernia and Post Operative Pain, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to compare the effects of ultrasound-guided lateral Quadratus Lumborum Block (QLB) and Transversalis Fascia Plane (TFP) block on postoperative analgesia in patients undergoing laparoscopic inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- İnguinal Hernia, Post Operative Pain
- What is being tested?
- Lateral Quadratus Lumborum Block, Transversalis Fascia Plane Block and Port Site Infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2026to 10 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for elective laparoscopic inguinal hernia repair.
- American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Age between 18 and 65 years.
- Provided written informed consent.
Who cannot join
- History of allergy to local anesthetics.
- Presence of coagulopathy.
- Signs of infection at the intended block application site.
- Body Mass Index (BMI) ≥ 35 kg/m².
- History of chronic opioid use.
- Presence of neurological disease.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Effects of Ultrasound-Guided Lateral Quadratus Lumborum Block and Transversalis Fascia Plane Block on Postoperative Analgesia in Patients Undergoing Laparoscopic Inguinal Hernia Repair: A Randomized Controlled Trial
This randomized controlled trial aims to compare the effects of ultrasound-guided lateral Quadratus Lumborum Block (QLB) and Transversalis Fascia Plane (TFP) block on postoperative analgesia in patients undergoing laparoscopic inguinal hernia repair. Ninety patients will be randomly assigned to one of three groups: Group QLB, Group TFP, or Group Control. The primary objective is to compare postoperative pain scores (NRS) at various time points within the first 24 hours. Secondary objectives include evaluating the need for rescue analgesia, total tramadol consumption, and the incidence of opioid-related side effects.
Read the detailed description
Laparoscopic inguinal hernia repair is a standard, minimally invasive procedure. However, moderate pain is common in the first 24 hours postoperatively, originating from somatic pain at trocar sites and visceral pain from peritoneal irritation and mesh placement. Multimodal analgesia, including fascial plane blocks, is recommended to reduce opioid consumption and improve pain control.
In this prospective, randomized, controlled, single-center trial, 90 patients (ASA I-III, aged 18-65) scheduled for elective laparoscopic inguinal hernia repair under general anesthesia will be allocated into three parallel arms (n=30 each) via computer-based randomization.
Group QLB: Will receive bilateral ultrasound-guided lateral Quadratus Lumborum Block (total 40 mL 0.25% bupivacaine) prior to extubation, along with 10 mL 0.25% bupivacaine infiltration at port sites.
Group TFP: Will receive bilateral ultrasound-guided Transversalis Fascia Plane Block (total 40 mL 0.25% bupivacaine) prior to extubation, along with 10 mL 0.25% bupivacaine infiltration at port sites.
Group Control: Will receive only port site infiltration (total 20 mL 0.25% bupivacaine).
All procedures will be performed aseptically by the same surgical and anesthesia team. Postoperatively, all patients will receive 1 g intravenous paracetamol every 8 hours. Postoperative pain will be assessed using the Numeric Rating Scale (NRS) by an anesthesiologist blinded to the group allocation. Intravenous tramadol (100 mg) will be administered as rescue analgesia if the NRS score is ≥ 4. Total 24-hour tramadol consumption, along with block-related complications and opioid-related side effects (nausea, vomiting, sedation), will be recorded.
- Conditions
- İnguinal Hernia, Post Operative Pain
- Being tested
- Lateral Quadratus Lumborum Block, Transversalis Fascia Plane Block, Port Site Infiltration
- Keywords
- Laparoscopic inguinal hernia, Quadratus Lumborum Block, Transversalis Fascia Plane Block, Postoperative analgesia, Regional anesthesia.
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Quadratus Lumborum BlockProcedure or surgery
Bilateral ultrasound-guided lateral QLB with 20 mL of 0.25% bupivacaine per side (total 40 mL). Plus, 10 mL of 0.25% bupivacaine infiltration at trocar insertion sites.
Transversalis Fascia Plane BlockProcedure or surgery
Bilateral ultrasound-guided TFP block with 20 mL of 0.25% bupivacaine per side (total 40 mL). Plus, 10 mL of 0.25% bupivacaine infiltration at trocar insertion sites.
Port Site InfiltrationProcedure or surgery
Local infiltration of 20 mL of 0.25% bupivacaine at the trocar insertion sites.
| Study group | Role | What they receive |
|---|---|---|
| Group QLB | Experimental | Patients will receive bilateral lateral Quadratus Lumborum Block (QLB) and port site infiltration at the end of the surgery. Receives: Procedure: Lateral Quadratus Lumborum Block |
| Group TFP | Experimental | Patients will receive bilateral Transversalis Fascia Plane (TFP) block and port site infiltration at the end of the surgery. Receives: Procedure: Transversalis Fascia Plane Block |
| Group Control | Active comparator | Patients will receive only port site infiltration at the end of the surgery. Receives: Procedure: Port Site Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) Pain Score
Postoperative pain intensity assessed using the Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain". Higher scores represent worse pain outcomes.
Measured: At 0, 3, 6, 12, 18, and 24 hours postoperatively.
Secondary outcomes (4)
Total Tramadol Consumption
The cumulative dose of intravenous tramadol (in milligrams) administered as rescue analgesia.
Measured: During the first 24 hours postoperatively.
Need for Rescue Analgesia
The number of patients requiring rescue analgesia (tramadol 100 mg IV) when the NRS score is ≥ 4.
Measured: During the first 24 hours postoperatively
Incidence of Opioid-Related Side Effects
The number of patients experiencing postoperative nausea, vomiting, or sedation.
Measured: During the first 24 hours postoperatively.
Incidence of Block-Related Complications
The number of patients experiencing complications related to the regional block application, such as hematoma, infection, or local anesthetic systemic toxicity (LAST).
Measured: During the first 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start10 Jun 2026 (estimated)
- Primary completion10 Apr 2027 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for İnguinal HerniaStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Omur, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604259
- Sponsor's protocol ID
- İnguinal QLB vs TFP
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Ultrasound-Guided Lateral Quadratus Lumborum Block and Transversalis Fascia Plane Block on Postoperative Analgesia in Patients Undergoing Laparoscopic Inguinal Hernia Repair: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07604259
- Acronym / sponsor ID
- İnguinal QLB vs TFP
- Conditions
- İnguinal Hernia, Post Operative Pain
- Keywords
- Laparoscopic inguinal hernia, Quadratus Lumborum Block, Transversalis Fascia Plane Block, Postoperative analgesia, Regional anesthesia.
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 10 Apr 2027 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 22 May 2026 (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.
This randomized controlled trial aims to compare the effects of ultrasound-guided lateral Quadratus Lumborum Block (QLB) and Transversalis Fascia Plane (TFP) block on postoperative analgesia in patients undergoing laparoscopic inguinal hernia repair. Ninety patients will be randomly assigned to one of three groups: Group QLB, Group TFP, or Group Control. The primary objective is to compare postoperative pain scores (NRS) at various time points within the first 24 hours. Secondary objectives include evaluating the need for rescue analgesia, total tramadol consumption, and the incidence of opioid-related side effects.
Detailed description
Laparoscopic inguinal hernia repair is a standard, minimally invasive procedure. However, moderate pain is common in the first 24 hours postoperatively, originating from somatic pain at trocar sites and visceral pain from peritoneal irritation and mesh placement. Multimodal analgesia, including fascial plane blocks, is recommended to reduce opioid consumption and improve pain control.
In this prospective, randomized, controlled, single-center trial, 90 patients (ASA I-III, aged 18-65) scheduled for elective laparoscopic inguinal hernia repair under general anesthesia will be allocated into three parallel arms (n=30 each) via computer-based randomization.
Group QLB: Will receive bilateral ultrasound-guided lateral Quadratus Lumborum Block (total 40 mL 0.25% bupivacaine) prior to extubation, along with 10 mL 0.25% bupivacaine infiltration at port sites.
Group TFP: Will receive bilateral ultrasound-guided Transversalis Fascia Plane Block (total 40 mL 0.25% bupivacaine) prior to extubation, along with 10 mL 0.25% bupivacaine infiltration at port sites.
Group Control: Will receive only port site infiltration (total 20 mL 0.25% bupivacaine).
All procedures will be performed aseptically by the same surgical and anesthesia team. Postoperatively, all patients will receive 1 g intravenous paracetamol every 8 hours. Postoperative pain will be assessed using the Numeric Rating Scale (NRS) by an anesthesiologist blinded to the group allocation. Intravenous tramadol (100 mg) will be administered as rescue analgesia if the NRS score is ≥ 4. Total 24-hour tramadol consumption, along with block-related complications and opioid-related side effects (nausea, vomiting, sedation), will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group QLB | Experimental | Procedure: Lateral Quadratus Lumborum BlockPatients will receive bilateral lateral Quadratus Lumborum Block (QLB) and port site infiltration at the end of the surgery. |
| Group TFP | Experimental | Procedure: Transversalis Fascia Plane BlockPatients will receive bilateral Transversalis Fascia Plane (TFP) block and port site infiltration at the end of the surgery. |
| Group Control | Active comparator | Procedure: Port Site InfiltrationPatients will receive only port site infiltration at the end of the surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled for elective laparoscopic inguinal hernia repair.
- American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Age between 18 and 65 years.
- Provided written informed consent.
Key exclusion criteria (7 listed)
- History of allergy to local anesthetics.
- Presence of coagulopathy.
- Signs of infection at the intended block application site.
- Body Mass Index (BMI) ≥ 35 kg/m².
- History of chronic opioid use.
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 |
|---|---|---|
| Lateral Quadratus Lumborum BlockBilateral ultrasound-guided lateral QLB with 20 mL of 0.25% bupivacaine per side (total 40 mL). Plus, 10 mL of 0.25% bupivacaine infiltration at trocar insertion sites. | Procedure or surgery | Group QLB |
| Transversalis Fascia Plane BlockBilateral ultrasound-guided TFP block with 20 mL of 0.25% bupivacaine per side (total 40 mL). Plus, 10 mL of 0.25% bupivacaine infiltration at trocar insertion sites. | Procedure or surgery | Group TFP |
| Port Site InfiltrationLocal infiltration of 20 mL of 0.25% bupivacaine at the trocar insertion sites. | Procedure or surgery | Group Control |
Primary outcome
Numeric Rating Scale (NRS) Pain Score
Time frame: At 0, 3, 6, 12, 18, and 24 hours postoperatively.
Postoperative pain intensity assessed using the Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain". Higher scores represent worse pain outcomes.
4 secondary outcomes
Total Tramadol Consumption
Time frame: During the first 24 hours postoperatively.
Need for Rescue Analgesia
Time frame: During the first 24 hours postoperatively
Incidence of Opioid-Related Side Effects
Time frame: During the first 24 hours postoperatively.
Incidence of Block-Related Complications
Time frame: During the first 24 hours postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral Quadratus Lumborum Block, Transversalis Fascia Plane Block and Port Site Infiltration in people with İnguinal Hernia and Post Operative Pain, run by Medipol University at 1 site 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Numeric Rating Scale (NRS) Pain Score (time frame: At 0, 3, 6, 12, 18, and 24 hours postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.