Pain ManagementQIPB RCTNCT07695987
Quadro-Iliac Plane Block for Analgesia After Lumbar Microdiscectomy
A study testing Ultrasound-Guided Quadro-Iliac Plane Block and Local Infiltration Analgesia (LIA) in people with Pain Management, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study will evaluate whether ultrasound-guided quadro-iliac plane block provides better postoperative pain control than local infiltration analgesia in patients undergoing single-level lumbar microdiscectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain Management
- What is being tested?
- Ultrasound-Guided Quadro-Iliac Plane Block and Local Infiltration Analgesia (LIA)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2026to 2 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 75 years
- American Society of Anesthesiologists physical status I to III
- Scheduled for elective single-level lumbar microdiscectomy, such as L4-L5 or L5-S1 disc herniation
- Planned surgery under general anesthesia
- Able to provide written informed consent
Who cannot join
- Allergy or hypersensitivity to local anesthetics
- Coagulopathy or active anticoagulant use
- Infection, scar tissue, or skin lesion at the injection site
- Pregnancy or breastfeeding
- Chronic pain syndrome or regular opioid use
- American Society of Anesthesiologists physical status IV or higher
- Planned surgery for two or more levels of disc herniation
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, 1 recruiting
- Recruiting
Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Istanbul, Istanbul, 34303
Engin ihsan Turan, 05382431114, enginihsan@hotmail.com
About this study
Official title: Effect of Ultrasound-Guided Quadro-Iliac Plane Block Compared With Local Infiltration Analgesia After Single-Level Lumbar Microdiscectomy: A Prospective, Double-Blind, Controlled, Multicenter Randomized Trial
This study will evaluate whether ultrasound-guided quadro-iliac plane block provides better postoperative pain control than local infiltration analgesia in patients undergoing single-level lumbar microdiscectomy.
Adult patients scheduled for elective single-level lumbar microdiscectomy will be randomly assigned to receive either bilateral quadro-iliac plane block plus patient-controlled analgesia or local infiltration analgesia plus patient-controlled analgesia. The main outcome of the study will be total fentanyl consumption during the first 24 hours after surgery. Pain scores, need for rescue analgesia, opioid-related side effects, patient satisfaction, and recovery quality will also be evaluated.
Read the detailed description
This is a prospective, randomized, double-blind, controlled, multicenter clinical trial designed to assess the analgesic efficacy of ultrasound-guided quadro-iliac plane block in patients undergoing elective single-level lumbar microdiscectomy.
Patients aged 18-75 years with American Society of Anesthesiologists physical status I-III who are scheduled for elective single-level lumbar microdiscectomy under general anesthesia will be included. Participants will be randomized into two groups. The intervention group will receive bilateral ultrasound-guided quadro-iliac plane block before emergence from anesthesia, followed by postoperative patient-controlled analgesia. The control group will receive local infiltration analgesia performed by the surgeon, followed by postoperative patient-controlled analgesia.
All patients will receive a standardized general anesthesia protocol. Postoperative analgesia will be provided using a fentanyl-based patient-controlled analgesia device. The primary outcome will be total fentanyl consumption during the first postoperative 24 hours. Secondary outcomes will include numerical rating scale pain scores at predefined postoperative time points, rescue analgesic requirement, opioid-related adverse effects such as nausea, vomiting, pruritus and respiratory depression, dermatomal sensory spread, and patient-reported recovery quality using the QoR-15 questionnaire.
- Conditions
- Pain Management
- Being tested
- Ultrasound-Guided Quadro-Iliac Plane Block, Local Infiltration Analgesia (LIA)
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Quadro-Iliac Plane BlockProcedure or surgery
Bilateral ultrasound-guided quadro-iliac plane block will be performed before emergence from general anesthesia in the prone position. After visualization of the quadratus lumborum muscle and iliac crest at the L3 level, 30 mL of 0.167% bupivacaine will be injected into the interfascial plane on each side. All participants will receive postoperative fentanyl-based patient-controlled analgesia.
Local Infiltration Analgesia (LIA)Procedure or surgery
Local infiltration analgesia will be performed by the surgeon before the end of surgery. A total dose of 50 mg of 0.25% bupivacaine will be infiltrated into the subcutaneous tissue. All participants will receive postoperative fentanyl-based patient-controlled analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Quadro-Iliac Plane Block Group | Active comparator | Participants in this group will receive bilateral ultrasound-guided quadro-iliac plane block before emergence from general anesthesia, followed by postoperative fentanyl-based patient-controlled analgesia. Receives: Procedure: Ultrasound-Guided Quadro-Iliac Plane Block |
| Local Infiltration Analgesia Group | Active comparator | Participants in this group will receive surgeon-performed local infiltration analgesia, followed by postoperative fentanyl-based patient-controlled analgesia. Receives: Procedure: Local Infiltration Analgesia (LIA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Fentanyl Consumption During the First 24 Hours After Surgery
Total postoperative fentanyl consumption administered via patient-controlled analgesia will be recorded during the first 24 hours after surgery.
Measured: Postoperative 0-24 hours
Secondary outcomes (5)
Postoperative Pain Scores at Rest and During Movement
Pain intensity will be assessed using the Numerical Rating Scale at rest and during movement. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: Postoperative 0, 1, 6, 12, and 24 hours
Number of Patients Require Rescue Analgesic
The need for rescue analgesia with intravenous tenoxicam will be recorded during the postoperative follow-up period.
Measured: Postoperative 0-24 hours
Opioid-Related Adverse Effects
Opioid-related adverse effects, including nausea, vomiting, pruritus, and respiratory depression, will be recorded.
Measured: Postoperative 0-24 hours
Quality of Recovery Score
Patient-reported recovery quality will be assessed using the Quality of Recovery-15 questionnaire (0-150). Higher value means better Quality of Recovery.
Measured: Postoperative 24 hours
Dermatomal Sensory Spread
Dermatomal sensory spread of the block will be evaluated using a cold test.
Measured: Postoperative 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start10 Jul 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion2 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engin Ihsan Turan, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695987
- Sponsor's protocol ID
- Quadroiliac plane block RCT
- Acronym
- QIPB RCT
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-Guided Quadro-Iliac Plane Block Compared With Local Infiltration Analgesia After Single-Level Lumbar Microdiscectomy: A Prospective, Double-Blind, Controlled, Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT07695987
- Acronym / sponsor ID
- QIPB RCT / Quadroiliac plane block RCT
- Conditions
- Pain Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 2 Dec 2026 (estimated)
- First posted
- 10 Jul 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 study will evaluate whether ultrasound-guided quadro-iliac plane block provides better postoperative pain control than local infiltration analgesia in patients undergoing single-level lumbar microdiscectomy.
Adult patients scheduled for elective single-level lumbar microdiscectomy will be randomly assigned to receive either bilateral quadro-iliac plane block plus patient-controlled analgesia or local infiltration analgesia plus patient-controlled analgesia. The main outcome of the study will be total fentanyl consumption during the first 24 hours after surgery. Pain scores, need for rescue analgesia, opioid-related side effects, patient satisfaction, and recovery quality will also be evaluated.
Detailed description
This is a prospective, randomized, double-blind, controlled, multicenter clinical trial designed to assess the analgesic efficacy of ultrasound-guided quadro-iliac plane block in patients undergoing elective single-level lumbar microdiscectomy.
Patients aged 18-75 years with American Society of Anesthesiologists physical status I-III who are scheduled for elective single-level lumbar microdiscectomy under general anesthesia will be included. Participants will be randomized into two groups. The intervention group will receive bilateral ultrasound-guided quadro-iliac plane block before emergence from anesthesia, followed by postoperative patient-controlled analgesia. The control group will receive local infiltration analgesia performed by the surgeon, followed by postoperative patient-controlled analgesia.
All patients will receive a standardized general anesthesia protocol. Postoperative analgesia will be provided using a fentanyl-based patient-controlled analgesia device. The primary outcome will be total fentanyl consumption during the first postoperative 24 hours. Secondary outcomes will include numerical rating scale pain scores at predefined postoperative time points, rescue analgesic requirement, opioid-related adverse effects such as nausea, vomiting, pruritus and respiratory depression, dermatomal sensory spread, and patient-reported recovery quality using the QoR-15 questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadro-Iliac Plane Block Group | Active comparator | Procedure: Ultrasound-Guided Quadro-Iliac Plane BlockParticipants in this group will receive bilateral ultrasound-guided quadro-iliac plane block before emergence from general anesthesia, followed by postoperative fentanyl-based patient-controlled analgesia. |
| Local Infiltration Analgesia Group | Active comparator | Procedure: Local Infiltration Analgesia (LIA)Participants in this group will receive surgeon-performed local infiltration analgesia, followed by postoperative fentanyl-based patient-controlled analgesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 75 years
- American Society of Anesthesiologists physical status I to III
- Scheduled for elective single-level lumbar microdiscectomy, such as L4-L5 or L5-S1 disc herniation
- Planned surgery under general anesthesia
- Able to provide written informed consent
Key exclusion criteria (7 listed)
- Allergy or hypersensitivity to local anesthetics
- Coagulopathy or active anticoagulant use
- Infection, scar tissue, or skin lesion at the injection site
- Pregnancy or breastfeeding
- Chronic pain syndrome or regular 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 |
|---|---|---|
| Ultrasound-Guided Quadro-Iliac Plane BlockBilateral ultrasound-guided quadro-iliac plane block will be performed before emergence from general anesthesia in the prone position. After visualization of the quadratus lumborum muscle and iliac crest at the L3 level, 30 mL of 0.167% bupivacaine will be injected into the interfascial plane on each side. All participants will receive postoperative fentanyl-based patient-controlled analgesia. | Procedure or surgery | Quadro-Iliac Plane Block Group |
| Local Infiltration Analgesia (LIA)Local infiltration analgesia will be performed by the surgeon before the end of surgery. A total dose of 50 mg of 0.25% bupivacaine will be infiltrated into the subcutaneous tissue. All participants will receive postoperative fentanyl-based patient-controlled analgesia. | Procedure or surgery | Local Infiltration Analgesia Group |
Primary outcome
Total Fentanyl Consumption During the First 24 Hours After Surgery
Time frame: Postoperative 0-24 hours
Total postoperative fentanyl consumption administered via patient-controlled analgesia will be recorded during the first 24 hours after surgery.
5 secondary outcomes
Postoperative Pain Scores at Rest and During Movement
Time frame: Postoperative 0, 1, 6, 12, and 24 hours
Number of Patients Require Rescue Analgesic
Time frame: Postoperative 0-24 hours
Opioid-Related Adverse Effects
Time frame: Postoperative 0-24 hours
Quality of Recovery Score
Time frame: Postoperative 24 hours
Dermatomal Sensory Spread
Time frame: Postoperative 2 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 30 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Quadro-Iliac Plane Block and Local Infiltration Analgesia (LIA) in people with Pain Management, run by Kanuni Sultan Suleyman Training and Research 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 5 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: looking for participants now, as of the sponsor's last update on 30 Jul 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 Engin ihsan Turan, principal investigator (+905382431114, drenginihsan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Fentanyl Consumption During the First 24 Hours After Surgery (time frame: Postoperative 0-24 hours). 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 30 Jul 2026.