Pain, PostoperativeNCT06664164
Postoperative Analgesic Efficacy of Adjuvant Quadratus Lumborum Block in Open Inguinal Hernia Surgery
A study testing ANTERİOR QUADRATUS LUMBORUM BLOCK and ANTERİOR QUADRATUS LUMBORUM BLOCK WİTH ADJUVANT in people with Pain, Postoperative, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Evaluation of Postoperative Analgesic Efficacy of Adjuvant Use in Quadratus Lumborum Blocks Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- ANTERİOR QUADRATUS LUMBORUM BLOCK and ANTERİOR QUADRATUS LUMBORUM BLOCK WİTH ADJUVANT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 13 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- local anesthetic allergy
- Infection at the procedure site
- Body Mass Index >35 kg/m2
- Anticoagulant use with bleeding disorder
- Chronic analgesia and opioid use -with mental and psychiatric disorders -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Research and Training Hospital
Istanbul, 34255
About this study
Official title: Comparison of Postoperative Analgesic Efficacy of Adjuvant Quadratus Lumborum Block in Open Technique Inguinal Hernia Surgeries
Evaluation of Postoperative Analgesic Efficacy of Adjuvant Use in Quadratus Lumborum Blocks
Read the detailed description
primary aim : Compare the time to first rescue analgesia in patients following the application of non-adjuvant Quadratus Lumborum Block and adjuvant Quadratus Lumborum Block for postoperative analgesia after inguinal hernia surgeries performed under spinal anesthesia.
secondary aims are to: to compare and evaluate the total analgesic consumption over 24 hours Compare NRS (Numerical Rating Scale) values (at rest and dynamic) in patients during postoperative follow-ups at 4, 8, 12, and 24 hours.
Compare side effects such as postoperative nausea and vomiting. In trunk blocks, local anesthesia is applied to the interfascial area between the abdominal wall or back muscles. Local anesthetics and steroids are used for this purpose. The analgesic efficacy of steroids is known from their perineural applications. Due to the lack of blood circulation and vascularization in the interfascial area, the absorption of local anesthetics is slow, providing prolonged analgesic effects. Trunk blocks applied in these regions are used as part of multimodal analgesia. The effectiveness of trunk blocks may vary based on the patient's anatomical differences and previous surgeries, but analgesic efficacy is generally observed for an average of 8-12 hours. the investigators believe that with the use of adjuvants, these durations will be extended, and analgesic efficacy will increase.
In this study, it is planned to add a total of 8 mg of dexamethasone to the local anesthetic agent for patients undergoing adjuvant anterior Quadratus Lumborum Block. In studies conducted in the field of trunk blocks, the expected duration of analgesia is an average of 8-12 hours. In this study, the block application is planned to be preoperative. Dexamethasone was chosen as an adjuvant to extend the expected analgesia duration of 8-12 hours and to increase analgesic efficacy. Dexamethasone is known to be effective and safe when used as an adjuvant in all nerve blocks.
To reduce opioid-related side effects such as nausea, vomiting, itching, constipation, and dependence associated with opioid medications used in postoperative analgesia for inguinal hernia surgeries, opioid-sparing analgesia and regional techniques are being employed. Quadratus Lumborum Blocks are being safely and easily performed and are frequently preferred in abdominal surgery due to recent advancements in trunk block techniques and ultrasound technology.
This study aims to evaluate the postoperative analgesic efficacy of adjuvant and non-adjuvant anterior Quadratus Lumborum Blocks in patients undergoing inguinal hernia surgery. The investigators predict that the analgesic efficacy of the adjuvant Quadratus Lumborum Block will be more effective and longer-lasting.
- Conditions
- Pain, Postoperative
- Being tested
- ANTERİOR QUADRATUS LUMBORUM BLOCK, ANTERİOR QUADRATUS LUMBORUM BLOCK WİTH ADJUVANT
- Keywords
- anterior quadratus lumborum block, postoperative pain, adjuvant, dexamethasone, inguinal hernia
- 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.
ANTERİOR QUADRATUS LUMBORUM BLOCKProcedure or surgery
Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected.
ANTERİOR QUADRATUS LUMBORUM BLOCK WİTH ADJUVANTProcedure or surgery
Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine and 8 mg de-xamethasone are injected.
| Study group | Role | What they receive |
|---|---|---|
| QLB Group | Active comparator | anterior quadratus lumborum block group Receives: Procedure: ANTERİOR QUADRATUS LUMBORUM BLOCK |
| adjuvant QLB Group | Active comparator | with adjuvant anterior quadratus lumborum block group Receives: Procedure: ANTERİOR QUADRATUS LUMBORUM BLOCK WİTH ADJUVANT |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first rescue analgesic requirement.
Compare the time to first rescue analgesia in patients
Measured: 24 hour
Secondary outcomes (3)
Total analgesic Consumption
Our primary aim is to compare and evaluate the total analgesic consumption(diclofenac) over 24 hours following the application of non-adjuvant Quadratus Lumborum Block and adjuvant Quadratus Lumborum Block for postoperative analgesia after inguinal hernia surgeries performed under spinal anesthesia.
Measured: 24 hour
To compare the NRS (Numering rating scale) values (resting and dynamic) at 4. 8. 12 . 24. hours in the postoperative follow-up of the patients
Compare NRS (Numerical Rating Scale) values (at rest and dynamic) in patients during . postoperative follow-ups at 4, 8, 12, and 24 hoursAssessed at various time points to quantify pain intensity at rest and during movement. The Numerical Rating Scale (NRS) is a pain assessment tool where patients rate their pain from 0 (no pain) to 10 (worst pain).
Measured: 24 hour
To compare postoperative side effects such as nausea, vomiting
To compare postoperative side effects such as nausea, vomiting, quadriceps weakness
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Nov 2024
- Primary completion12 Aug 2025
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, SERPİL ŞEHİRLİOĞLU, Gaziosmanpasa Research and Education Hospital
- Investigators
- Serpil Sehirlioglu, MD, Principal investigator, Gaziosmanpasa Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664164
- Sponsor's protocol ID
- GAZIAOSMANPASA TREHAQ
- Status last verified
- Aug 2025
- First submitted
- 27 Oct 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data associated with the paper are not publicly available but are available from the corresponding author on reasonable request.
Publications
Priyadarshini K, Behera BK, Tripathy BB, Misra S. Ultrasound-guided transverse abdominis plane block, ilioinguinal/iliohypogastric nerve block, and quadratus lumborum block for elective open inguinal hernia repair in children: a randomized controlled trial. Reg Anesth Pain Med. 2022 Apr;47(4):217-221. doi: 10.1136/rapm-2021-103201. Epub 2022 Jan 17.
PubMed 35039439Favaro ML, Gabor S, Souza DBF, Araujo AA, Milani ALC, Ribeiro Junior MAF. Quadratus Lumborum Block As A Single Anesthetic Method For Laparoscopic Totally Extraperitoneal (Tep) Inguinal Hernia Repair: A Randomized Clinical Trial. Sci Rep. 2020 May 22;10(1):8526. doi: 10.1038/s41598-020-65604-x.
PubMed 32444629
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Efficacy of Adjuvant Quadratus Lumborum Block in Open Technique Inguinal Hernia Surgeries
- ClinicalTrials.gov ID
- NCT06664164
- Acronym / sponsor ID
- GAZIAOSMANPASA TREHAQ
- Conditions
- Pain, Postoperative
- Keywords
- anterior quadratus lumborum block, postoperative pain, adjuvant, dexamethasone, inguinal hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 12 Aug 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 29 Oct 2024 (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.
Evaluation of Postoperative Analgesic Efficacy of Adjuvant Use in Quadratus Lumborum Blocks
Detailed description
primary aim : Compare the time to first rescue analgesia in patients following the application of non-adjuvant Quadratus Lumborum Block and adjuvant Quadratus Lumborum Block for postoperative analgesia after inguinal hernia surgeries performed under spinal anesthesia.
secondary aims are to: to compare and evaluate the total analgesic consumption over 24 hours Compare NRS (Numerical Rating Scale) values (at rest and dynamic) in patients during postoperative follow-ups at 4, 8, 12, and 24 hours.
Compare side effects such as postoperative nausea and vomiting. In trunk blocks, local anesthesia is applied to the interfascial area between the abdominal wall or back muscles. Local anesthetics and steroids are used for this purpose. The analgesic efficacy of steroids is known from their perineural applications. Due to the lack of blood circulation and vascularization in the interfascial area, the absorption of local anesthetics is slow, providing prolonged analgesic effects. Trunk blocks applied in these regions are used as part of multimodal analgesia. The effectiveness of trunk blocks may vary based on the patient's anatomical differences and previous surgeries, but analgesic efficacy is generally observed for an average of 8-12 hours. the investigators believe that with the use of adjuvants, these durations will be extended, and analgesic efficacy will increase.
In this study, it is planned to add a total of 8 mg of dexamethasone to the local anesthetic agent for patients undergoing adjuvant anterior Quadratus Lumborum Block. In studies conducted in the field of trunk blocks, the expected duration of analgesia is an average of 8-12 hours. In this study, the block application is planned to be preoperative. Dexamethasone was chosen as an adjuvant to extend the expected analgesia duration of 8-12 hours and to increase analgesic efficacy. Dexamethasone is known to be effective and safe when used as an adjuvant in all nerve blocks.
To reduce opioid-related side effects such as nausea, vomiting, itching, constipation, and dependence associated with opioid medications used in postoperative analgesia for inguinal hernia surgeries, opioid-sparing analgesia and regional techniques are being employed. Quadratus Lumborum Blocks are being safely and easily performed and are frequently preferred in abdominal surgery due to recent advancements in trunk block techniques and ultrasound technology.
This study aims to evaluate the postoperative analgesic efficacy of adjuvant and non-adjuvant anterior Quadratus Lumborum Blocks in patients undergoing inguinal hernia surgery. The investigators predict that the analgesic efficacy of the adjuvant Quadratus Lumborum Block will be more effective and longer-lasting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLB Group | Active comparator | Procedure: ANTERİOR QUADRATUS LUMBORUM BLOCKanterior quadratus lumborum block group |
| adjuvant QLB Group | Active comparator | Procedure: ANTERİOR QUADRATUS LUMBORUM BLOCK WİTH ADJUVANTwith adjuvant anterior quadratus lumborum block group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- local anesthetic allergy
- Infection at the procedure site
- Body Mass Index >35 kg/m2
- Anticoagulant use with bleeding disorder
- Chronic analgesia and opioid use -with mental and psychiatric disorders -
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 |
|---|---|---|
| ANTERİOR QUADRATUS LUMBORUM BLOCKPatients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. | Procedure or surgery | QLB Group |
| ANTERİOR QUADRATUS LUMBORUM BLOCK WİTH ADJUVANTPatients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine and 8 mg de-xamethasone are injected. | Procedure or surgery | adjuvant QLB Group |
Primary outcome
time to first rescue analgesic requirement.
Time frame: 24 hour
Compare the time to first rescue analgesia in patients
3 secondary outcomes
Total analgesic Consumption
Time frame: 24 hour
To compare the NRS (Numering rating scale) values (resting and dynamic) at 4. 8. 12 . 24. hours in the postoperative follow-up of the patients
Time frame: 24 hour
To compare postoperative side effects such as nausea, vomiting
Time frame: 24 hour
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 28 Aug 2025.
- Results publication: PubMed 35039439Priyadarshini K, Behera BK, Tripathy BB, Misra S. Ultrasound-guided transverse abdominis plane block, ilioinguinal/iliohypogastric nerve block, and quadratus lumborum block for elective open inguinal hernia repair in children: a randomized controlled trial. Reg Anesth Pain Med. 2022 Apr;47(4):217-221. doi: 10.1136/rapm-2021-103201. Epub 2022 Jan 17.
- Results publication: PubMed 32444629Favaro ML, Gabor S, Souza DBF, Araujo AA, Milani ALC, Ribeiro Junior MAF. Quadratus Lumborum Block As A Single Anesthetic Method For Laparoscopic Totally Extraperitoneal (Tep) Inguinal Hernia Repair: A Randomized Clinical Trial. Sci Rep. 2020 May 22;10(1):8526. doi: 10.1038/s41598-020-65604-x.
- Individual participant dataSharing planned: Yes. The data associated with the paper are not publicly available but are available from the corresponding author on reasonable request.
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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.
Serpil Sehirlioglu, MD principal investigator
Gaziosmanpasa Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANTERİOR QUADRATUS LUMBORUM BLOCK and ANTERİOR QUADRATUS LUMBORUM BLOCK WİTH ADJUVANT in people with Pain, Postoperative, run by Gaziosmanpasa Research and Education Hospital 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 0 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 28 Aug 2025. 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?
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?
time to first rescue analgesic requirement. (time frame: 24 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 NCT06664164, which also lists 2 linked publications.
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 28 Aug 2025.