Pain, PostoperativeNCT07370415
mTLIP vs QIPB for Postoperative Analgesia After Lumbar Instrumentation Surgery
A study testing Modified Thoracolumbar Interfascial Plane Block (mTLIP) and Quadro-Iliac Plane Block (QIPB): in people with Pain, Postoperative, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Lumbar instrumentation surgery is associated with severe postoperative pain due to extensive tissue dissection and prolonged muscle retraction during the procedure. Inadequate postoperative pain control may result in delayed mobilization, increased cardiopulmonary complications, and prolonged hospital stay. 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?
- Modified Thoracolumbar Interfascial Plane Block (mTLIP) and Quadro-Iliac Plane Block (QIPB):
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2026to 30 Sep 2026
- 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
- Age between 18 and 65 years
- Classified as American Society of Anesthesiologists physical status I-III
- Scheduled for elective lumbar instrumentation surgery under general anesthesia
- Provision of written informed consent
Who cannot join
- Use of anticoagulant medications or presence of bleeding diathesis
- Known allergy or hypersensitivity to local anesthetics or opioid drugs
- Infection at the planned block site
- Alcohol or drug dependence
- Cognitive impairment preventing reliable pain assessment
- Pregnancy or lactation
Show all 9Show fewer
- History of previous lumbar spine surgery
- Diabetes mellitus
- Renal or hepatic insufficiency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bursa City Hospital
Nilufer, Bursa, 16110
Merih Yildiz Eglen, MD, +905059340629, meriheg@yahoo.com
About this study
Official title: Comparison of Ultrasound-Guided Modified Thoracolumbar Interfascial Plane Block Versus Quadro-Iliac Plane Block for Postoperative Analgesia After Lumbar Instrumentation Surgery
Lumbar instrumentation surgery is associated with severe postoperative pain due to extensive tissue dissection and prolonged muscle retraction during the procedure. Inadequate postoperative pain control may result in delayed mobilization, increased cardiopulmonary complications, and prolonged hospital stay. Ultrasound-guided regional analgesia techniques are increasingly used to improve postoperative pain management after lumbar spine surgery. The thoracolumbar interfascial plane (TLIP) block has been shown to provide effective analgesia for lumbar instrumentation surgery, and its modified technique (mTLIP) has been reported to enhance postoperative pain control. The quadro-iliac plane (QIP) block is a newly described fascial plane block with promising results in lumbar spine surgery. This randomized controlled trial aims to compare the postoperative analgesic effectiveness of the modified thoracolumbar interfascial plane block and the quadro-iliac plane block in patients undergoing lumbar instrumentation surgery.
Read the detailed description
Lumbar instrumentation surgery is commonly associated with moderate-to-severe postoperative pain due to extensive tissue dissection and prolonged muscle retraction. Inadequate pain control may lead to delayed mobilization, increased cardiopulmonary complications, and prolonged hospital stay.
Ultrasound-guided regional analgesia techniques, particularly fascial plane blocks, are increasingly used as part of multimodal analgesia in lumbar spine surgery. The thoracolumbar interfascial plane (TLIP) block is an established technique that provides effective analgesia and has been modified to improve its clinical application, resulting in the modified thoracolumbar interfascial plane (mTLIP) block. Previous studies have demonstrated the effectiveness of mTLIP for postoperative analgesia after lumbar instrumentation surgery.
The quadro-iliac plane block (QIPB) is a recently described ultrasound-guided fascial plane block. Early reports suggest that QIPB may provide effective analgesia in lumbar spine procedures; however, comparative evidence with established techniques remains limited.
This prospective randomized controlled trial aims to compare bilateral ultrasound-guided mTLIP and QIPB performed at the end of surgery in patients undergoing elective lumbar instrumentation surgery under general anesthesia, to evaluate whether QIPB can be considered a safe and effective alternative to mTLIP for postoperative analgesia.
- Conditions
- Pain, Postoperative
- Being tested
- Modified Thoracolumbar Interfascial Plane Block (mTLIP), Quadro-Iliac Plane Block (QIPB):
- Keywords
- Lumbar instrumentation surgery, Postoperative Pain, Modified thoracolumbar interfascial plane block, Quadro-iliac plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Thoracolumbar Interfascial Plane Block (mTLIP)Procedure or surgery
An ultrasound-guided bilateral fascial plane block in which local anesthetic is injected into the interfascial plane between the longissimus and iliocostalis muscles at the operated lumbar levels. The block is performed under sterile conditions at the end of surgery using 0.25% bupivacaine (20 mL per side; total volume 40 mL).
Quadro-Iliac Plane Block (QIPB):Procedure or surgery
An ultrasound-guided bilateral fascial plane block in which local anesthetic is injected at the point where the quadratus lumborum muscle attaches to the iliac crest, allowing spread between the erector spinae and quadratus lumborum muscles. The block is performed under sterile conditions at the end of surgery using 0.25% bupivacaine (20 mL per side; total volume 40 mL).
| Study group | Role | What they receive |
|---|---|---|
| Modified Thoracolumbar Interfascial Plane Block (mTLIP) Group | Experimental | Participants in this group will receive a bilateral ultrasound-guided modified thoracolumbar interfascial plane block (mTLIP) performed at the end of lumbar instrumentation surgery while in the prone position. Under sterile conditions, the ultrasound probe will be placed in the parasagittal plane at the midpoint of the surgical incision, taking into account the operated lumbar levels. The paraspinal muscles will be identified, and using an in-plane technique, the needle will be advanced into the interfascial plane between the longissimus and iliocostalis muscles. After confirmation of correct needle placement with saline, 20 mL of 0.25% bupivacaine will be injected on each side. The block will be performed bilaterally, with a total volume of 40 mL of 0.25% bupivacaine. Receives: Procedure: Modified Thoracolumbar Interfascial Plane Block (mTLIP) |
| Quadro-Iliac Plane Block (QIPB) Group | Experimental | Participants in this group will receive a bilateral ultrasound-guided quadro-iliac plane block (QIPB) performed at the end of lumbar instrumentation surgery while in the prone position. Under sterile conditions, a convex ultrasound probe will be placed at the point where the quadratus lumborum muscle attaches to the iliac crest. The erector spinae and quadratus lumborum muscles will be identified, and correct needle placement will be confirmed with saline injection. Subsequently, 20 mL of 0.25% bupivacaine will be injected on each side, with visualization of local anesthetic spread between the erector spinae and quadratus lumborum muscles. The block will be performed bilaterally, with a total volume of 40 mL of 0.25% bupivacaine. Receives: Procedure: Quadro-Iliac Plane Block (QIPB): |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative 48-Hour PCA Opioid Consumption
Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 48 hours after surgery, recorded in milligrams (mg).
Measured: Postoperative 0-8, 8-16, 16-24, 24-48 intervals
Secondary outcomes (6)
QoR-15 Recovery Score
The investigators will use the Turkish version of Quality of Recovery (QoR) / QoR-15 questionairre
PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent])
Able to breathe easily Been able to enjoy food Feeling rested Have had a good sleep Able to look after personal toilet and hygiene unaided Able to communicate with Getting support from hospital doctors and nurses Able to return to work or usual home activities Feeling comfortable and in control Having a feeling of general well-being
PART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time [excellent] and 0 = all of the time [poor]) Moderate pain Severe pain Nausea or vomiting Feeling worried or anxious Feeling sad or depressed
Measured: Postoperative 24th and 48th hours
Dynamic and static Numeric Rating Scale scores
Numeric Rating Scale (NRS) (0-10; 0= no pain, 10 = the most severe pain felt) pain scores at rest or movement at predefined postoperative hours
Measured: 0, 2, 4, 8, 16, 24, and 48 hours postoperatively
Total rescue analgesic dose
Despite the use of patient-controlled analgesia (PCA), if the Numeric Rating Scale (NRS) score is ≥4 at any time point, 0.5 mg/kg intravenous meperidine will be administered as rescue analgesia.
Total amount of meperidin during the first 24 and 48 hours after surgery, recorded in milligrams (mg).
Measured: Postoperative 48 hours
Time of first request for rescue analgesia
Despite the use of patient-controlled analgesia (PCA), if the Numeric Rating Scale (NRS) score is ≥4 at any time point, 0.5 mg/kg intravenous meperidine will be administered as rescue analgesia.
Measured: Postoperative 48 hours
Length of Hospital Stay
Length of hospital stay will be defined as the number of days from the end of surgery to hospital discharge
Measured: Patients will remain under observation for at least 2 weeks until their postoperative discharge. Follow-up will be completed upon discharge. The length of hospital stay will be recorded.
Block and Opioid-Related Adverse Effects and Complications
Block- and opioid-related adverse effects and complications, including but not limited to local anesthetic toxicity, hematoma, infection, nerve injury, nausea, vomiting, pruritus, sedation, and respiratory depression, will be recorded
Measured: Postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start20 Mar 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Merih Yıldız Eglen, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370415
- Sponsor's protocol ID
- BursaCity Hos 3
- Status last verified
- Mar 2026
- First submitted
- 12 Jan 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Girit M, Akin T, Narayanan M, Alici HA. Ultrasound guided quadro-iliac plane block: another novel fascial plane block. Pain Med. 2024 May 3;25(6):370-373. doi: 10.1093/pm/pnae018.
PubMed 38459608Turan EI, Sahin AS. Quadro-iliac plane block (QIPB) in lumbar stabilisation surgeries: A case series. Indian J Anaesth. 2025 Feb;69(2):244-245. doi: 10.4103/ija.ija_1077_24. Epub 2025 Jan 29. No abstract available.
PubMed 40160919Ciftci B, Ekinci M. A prospective and randomized trial comparing modified and classical techniques of ultrasound-guided thoracolumbar interfascial plane block. Agri. 2020 Nov;32(4):186-192. doi: 10.14744/agri.2020.72325.
PubMed 33398870
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-Guided Modified Thoracolumbar Interfascial Plane Block Versus Quadro-Iliac Plane Block for Postoperative Analgesia After Lumbar Instrumentation Surgery
- ClinicalTrials.gov ID
- NCT07370415
- Acronym / sponsor ID
- BursaCity Hos 3
- Conditions
- Pain, Postoperative
- Keywords
- Lumbar instrumentation surgery, Postoperative Pain, Modified thoracolumbar interfascial plane block, Quadro-iliac plane block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 27 Jan 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.
Lumbar instrumentation surgery is associated with severe postoperative pain due to extensive tissue dissection and prolonged muscle retraction during the procedure. Inadequate postoperative pain control may result in delayed mobilization, increased cardiopulmonary complications, and prolonged hospital stay. Ultrasound-guided regional analgesia techniques are increasingly used to improve postoperative pain management after lumbar spine surgery. The thoracolumbar interfascial plane (TLIP) block has been shown to provide effective analgesia for lumbar instrumentation surgery, and its modified technique (mTLIP) has been reported to enhance postoperative pain control. The quadro-iliac plane (QIP) block is a newly described fascial plane block with promising results in lumbar spine surgery. This randomized controlled trial aims to compare the postoperative analgesic effectiveness of the modified thoracolumbar interfascial plane block and the quadro-iliac plane block in patients undergoing lumbar instrumentation surgery.
Detailed description
Lumbar instrumentation surgery is commonly associated with moderate-to-severe postoperative pain due to extensive tissue dissection and prolonged muscle retraction. Inadequate pain control may lead to delayed mobilization, increased cardiopulmonary complications, and prolonged hospital stay.
Ultrasound-guided regional analgesia techniques, particularly fascial plane blocks, are increasingly used as part of multimodal analgesia in lumbar spine surgery. The thoracolumbar interfascial plane (TLIP) block is an established technique that provides effective analgesia and has been modified to improve its clinical application, resulting in the modified thoracolumbar interfascial plane (mTLIP) block. Previous studies have demonstrated the effectiveness of mTLIP for postoperative analgesia after lumbar instrumentation surgery.
The quadro-iliac plane block (QIPB) is a recently described ultrasound-guided fascial plane block. Early reports suggest that QIPB may provide effective analgesia in lumbar spine procedures; however, comparative evidence with established techniques remains limited.
This prospective randomized controlled trial aims to compare bilateral ultrasound-guided mTLIP and QIPB performed at the end of surgery in patients undergoing elective lumbar instrumentation surgery under general anesthesia, to evaluate whether QIPB can be considered a safe and effective alternative to mTLIP for postoperative analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Thoracolumbar Interfascial Plane Block (mTLIP) Group | Experimental | Procedure: Modified Thoracolumbar Interfascial Plane Block (mTLIP)Participants in this group will receive a bilateral ultrasound-guided modified thoracolumbar interfascial plane block (mTLIP) performed at the end of lumbar instrumentation surgery while in the prone position. Under sterile conditions, the ultrasound probe will be placed in the parasagittal plane at the midpoint of the surgical incision, taking into account the operated lumbar levels. The paraspinal muscles will be identified, and using an in-plane technique, the needle will be advanced into the interfascial plane between the longissimus and iliocostalis muscles. After confirmation of correct needle placement with saline, 20 mL of 0.25% bupivacaine will be injected on each side. The block will be performed bilaterally, with a total volume of 40 mL of 0.25% bupivacaine. |
| Quadro-Iliac Plane Block (QIPB) Group | Experimental | Procedure: Quadro-Iliac Plane Block (QIPB):Participants in this group will receive a bilateral ultrasound-guided quadro-iliac plane block (QIPB) performed at the end of lumbar instrumentation surgery while in the prone position. Under sterile conditions, a convex ultrasound probe will be placed at the point where the quadratus lumborum muscle attaches to the iliac crest. The erector spinae and quadratus lumborum muscles will be identified, and correct needle placement will be confirmed with saline injection. Subsequently, 20 mL of 0.25% bupivacaine will be injected on each side, with visualization of local anesthetic spread between the erector spinae and quadratus lumborum muscles. The block will be performed bilaterally, with a total volume of 40 mL of 0.25% bupivacaine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 65 years
- Classified as American Society of Anesthesiologists physical status I-III
- Scheduled for elective lumbar instrumentation surgery under general anesthesia
- Provision of written informed consent
Key exclusion criteria (9 listed)
- Use of anticoagulant medications or presence of bleeding diathesis
- Known allergy or hypersensitivity to local anesthetics or opioid drugs
- Infection at the planned block site
- Alcohol or drug dependence
- Cognitive impairment preventing reliable pain assessment
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 |
|---|---|---|
| Modified Thoracolumbar Interfascial Plane Block (mTLIP)An ultrasound-guided bilateral fascial plane block in which local anesthetic is injected into the interfascial plane between the longissimus and iliocostalis muscles at the operated lumbar levels. The block is performed under sterile conditions at the end of surgery using 0.25% bupivacaine (20 mL per side; total volume 40 mL). | Procedure or surgery | Modified Thoracolumbar Interfascial Plane Block (mTLIP) Group |
| Quadro-Iliac Plane Block (QIPB):An ultrasound-guided bilateral fascial plane block in which local anesthetic is injected at the point where the quadratus lumborum muscle attaches to the iliac crest, allowing spread between the erector spinae and quadratus lumborum muscles. The block is performed under sterile conditions at the end of surgery using 0.25% bupivacaine (20 mL per side; total volume 40 mL). | Procedure or surgery | Quadro-Iliac Plane Block (QIPB) Group |
Primary outcome
Postoperative 48-Hour PCA Opioid Consumption
Time frame: Postoperative 0-8, 8-16, 16-24, 24-48 intervals
Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 48 hours after surgery, recorded in milligrams (mg).
6 secondary outcomes
QoR-15 Recovery Score
Time frame: Postoperative 24th and 48th hours
Dynamic and static Numeric Rating Scale scores
Time frame: 0, 2, 4, 8, 16, 24, and 48 hours postoperatively
Total rescue analgesic dose
Time frame: Postoperative 48 hours
Time of first request for rescue analgesia
Time frame: Postoperative 48 hours
Length of Hospital Stay
Time frame: Patients will remain under observation for at least 2 weeks until their postoperative discharge. Follow-up will be completed upon discharge. The length of hospital stay will be recorded.
Block and Opioid-Related Adverse Effects and Complications
Time frame: Postoperative 48 hours
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 6 Mar 2026.
- Results publication: PubMed 38459608Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Girit M, Akin T, Narayanan M, Alici HA. Ultrasound guided quadro-iliac plane block: another novel fascial plane block. Pain Med. 2024 May 3;25(6):370-373. doi: 10.1093/pm/pnae018.
- Results publication: PubMed 40160919Turan EI, Sahin AS. Quadro-iliac plane block (QIPB) in lumbar stabilisation surgeries: A case series. Indian J Anaesth. 2025 Feb;69(2):244-245. doi: 10.4103/ija.ija_1077_24. Epub 2025 Jan 29. No abstract available.
- Results publication: PubMed 33398870Ciftci B, Ekinci M. A prospective and randomized trial comparing modified and classical techniques of ultrasound-guided thoracolumbar interfascial plane block. Agri. 2020 Nov;32(4):186-192. doi: 10.14744/agri.2020.72325.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Thoracolumbar Interfascial Plane Block (mTLIP) and Quadro-Iliac Plane Block (QIPB): in people with Pain, Postoperative, run by Bursa City 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 4 inclusion and 9 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 6 Mar 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?
Contact Merih Yildiz Eglen, MD (+905059340629, meriheg@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative 48-Hour PCA Opioid Consumption (time frame: Postoperative 0-8, 8-16, 16-24, 24-48 intervals). 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 NCT07370415, which also lists 3 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 6 Mar 2026.