Femur FractureNCT07009782
Evaluation of the Postoperative Analgesic Efficacy of the Quadroiliac Plane (QIP) Block in Femur Fracture Surgery
A study testing QIP block in people with Femur Fracture, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn whether the Quadroiliac Plane (QIP) block helps reduce postoperative opioid use in adults undergoing femur fracture surgery. It will also evaluate the pain control effectiveness, dermatomal spread, and safety of the QIP block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femur Fracture
- What is being tested?
- QIP block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 15 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older
- Scheduled for partial hip arthroplasty due to femur fracture
- ASA physical status classification I to III
- No contraindications to regional anesthesia or study medications
- Capable of understanding and using patient-controlled analgesia (PCA)
- Provided written informed consent
Who cannot join
- ASA classification IV or higher
- History of bleeding disorders or use of anticoagulant therapy
- Known allergy to local anesthetics
- Presence of neuropathic pain disorders
- Undergoing emergency surgery
- Unable to operate PCA device
- Declined to participate or refused consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Istanbul, Istanbul, 34303
About this study
The goal of this clinical trial is to learn whether the Quadroiliac Plane (QIP) block helps reduce postoperative opioid use in adults undergoing femur fracture surgery. It will also evaluate the pain control effectiveness, dermatomal spread, and safety of the QIP block. The main questions it aims to answer are:
Does the QIP block reduce total opioid (fentanyl) consumption within 24 hours after surgery?
Read more
Does the QIP block reduce the need for rescue analgesia?
What is the extent of dermatomal spread and are there any side effects or complications?
Researchers will compare patients receiving the QIP block to those receiving standard care without a block to see if the QIP block improves pain management outcomes.
Participants will:
Undergo femur fracture surgery under spinal anesthesia
Be randomly assigned to receive either the QIP block or no block after surgery
Use a patient-controlled analgesia (PCA) device with fentanyl
Have their pain scores, drug use, and recovery quality measured over 24 hours
Undergo a cold test at 2 hours post-op and complete a recovery questionnaire at 24 hours
Read the detailed description
This is a prospective, randomized, controlled, single-center clinical trial designed to evaluate the postoperative analgesic efficacy of the Quadroiliac Plane (QIP) block in patients undergoing femur fracture surgery, specifically partial hip arthroplasty under spinal anesthesia. The primary objective of the study is to assess the impact of the QIP block on total opioid consumption (fentanyl via PCA) during the first 24 hours postoperatively. Secondary objectives include evaluation of rescue analgesia needs, dermatomal spread of the block, incidence of motor block or complications, block feasibility and application time, patient satisfaction, and length of hospital stay.
Eligible participants aged 18 years or older who are scheduled for elective partial hip arthroplasty due to femoral neck fracture and meet inclusion criteria will be invited to participate. After obtaining written informed consent, patients will be randomly assigned to one of two groups using a computer-generated sequence and sealed envelope method. The intervention group will receive a QIP block postoperatively using 40 mL of 0.25% bupivacaine under ultrasound guidance. The control group will receive no regional block. Both groups will receive standard postoperative multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with fentanyl.
Pain will be assessed using the Numerical Rating Scale (NRS), which ranges from 0 (no pain) to 10 (worst imaginable pain), at rest and with movement at 0, 6, 12, and 24 hours postoperatively. Rescue analgesia (50 mg dexketoprofen IV over 20 minutes) will be administered if needed. The dermatomal spread of the block will be evaluated using an alcohol-based cold test at 2 hours postoperatively. At 24 hours, all patients will complete the Quality of Recovery-15 (QOR-15) questionnaire, which scores recovery from 0 (poor recovery) to 150 (excellent recovery).
- Conditions
- Femur Fracture
- Being tested
- QIP block
- Keywords
- Postoperative Pain
- Medical subject headings
- Femoral Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QIP blockProcedure or surgery
The Quadroiliac Plane (QIP) block is a novel ultrasound-guided fascial plane block. In this study, it will be performed postoperatively under spinal anesthesia in the prone position. A low-frequency convex transducer will be used to visualize the quadratus lumborum muscle at its attachment to the inner iliac crest. Using an in-plane technique with a 22G x 100 mm needle, 40 mL of 0.25% bupivacaine will be injected into the fascial plane beneath the quadratus lumborum muscle. The block will be performed unilaterally on the surgical side. The aim is to provide postoperative analgesia in patients undergoing femur fracture surgery.
| Study group | Role | What they receive |
|---|---|---|
| QIP Block Group | Experimental | Participants in this group will receive a Quadroiliac Plane (QIP) block using 40 mL of 0.25% bupivacaine under ultrasound guidance, applied postoperatively while in the prone position. The block will be performed only on the surgical side. All patients will also receive standard postoperative multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with fentanyl. Receives: Procedure: QIP block |
| Control Group | No intervention | Participants in this group will not receive a regional block. They will be managed with standard postoperative multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with fentanyl. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid Consumption Within the First 24 Hours Postoperatively
The total amount of fentanyl (in micrograms) administered via intravenous patient-controlled analgesia (PCA) will be recorded during the first 24 hours after surgery. This will be used to assess the analgesic efficacy of the Quadroiliac Plane (QIP) block compared to standard care without a block.
Measured: 24 hours postoperatively
Secondary outcomes (5)
Rescue Analgesia Requirement
The number of patients who require additional rescue analgesia (50 mg intravenous dexketoprofen) within the first 24 hours postoperatively will be recorded.
Measured: 24 hours
Pain Scores at Rest and on Movement
Pain intensity will be measured using the Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Assessments will be conducted both at rest and during movement at 0, 6, 12, and 24 hours after surgery. Higher scores indicate worse pain.
Measured: 0,6,12 and 24 hours
Extent of Dermatomal Coverage Measured by Cold Sensation Response to Alcohol Swab at 2 Hours Post-QIP Block
Dermatomal spread will be assessed using an alcohol-based cold test 2 hours after administration of the Quadroiliac Plane (QIP) Block. A trained clinician will apply alcohol-soaked gauze to the skin in a cranio-caudal direction along the abdomen and hip region. The patient will be asked to report changes in cold sensation compared to unblocked areas. The lowest and highest dermatomes with altered cold sensation (reduced or absent) will be recorded for each side.
Measured: 2 hours postoperatively
Postoperative Recovery Quality
Patients will complete the Quality of Recovery-15 (QoR-15) questionnaire 24 hours after surgery to evaluate their postoperative recovery experience. The QoR-15 consists of 15 items, each scored from 0 to 10, resulting in a total score range of 0 to 150. Higher scores indicate better recovery and a more favorable patient-reported outcome
Measured: 24 hours postoperatively
Block-Related Complications
Any complications or side effects related to the QIP block (e.g., motor block, hematoma, infection) will be recorded.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 Jun 2025
- Primary completion1 Oct 2025
- Study completion15 Oct 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 Femur FractureStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
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
- Investigators
- Engin ihsan Turan, Specialist, Principal investigator, Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009782
- Sponsor's protocol ID
- QIPB in femur fractures
- Status last verified
- Nov 2025
- First submitted
- 28 May 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Turan EI, Baydemir AE, Sahin AS. Efficacy of the quadro-iliac plane block in postoperative pain management for proximal femoral nail surgeries. Minerva Anestesiol. 2025 Mar;91(3):221-223. doi: 10.23736/S0375-9393.24.18506-9. Epub 2024 Nov 4. No abstract available.
PubMed 39495169
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Postoperative Analgesic Efficacy of the Quadroiliac Plane (QIP) Block in Femur Fracture Surgery
- ClinicalTrials.gov ID
- NCT07009782
- Acronym / sponsor ID
- QIPB in femur fractures
- Conditions
- Femur Fracture
- Keywords
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 8 Jun 2025 (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.
The goal of this clinical trial is to learn whether the Quadroiliac Plane (QIP) block helps reduce postoperative opioid use in adults undergoing femur fracture surgery. It will also evaluate the pain control effectiveness, dermatomal spread, and safety of the QIP block. The main questions it aims to answer are:
Does the QIP block reduce total opioid (fentanyl) consumption within 24 hours after surgery?
Does the QIP block reduce the need for rescue analgesia?
What is the extent of dermatomal spread and are there any side effects or complications?
Researchers will compare patients receiving the QIP block to those receiving standard care without a block to see if the QIP block improves pain management outcomes.
Participants will:
Undergo femur fracture surgery under spinal anesthesia
Be randomly assigned to receive either the QIP block or no block after surgery
Use a patient-controlled analgesia (PCA) device with fentanyl
Have their pain scores, drug use, and recovery quality measured over 24 hours
Undergo a cold test at 2 hours post-op and complete a recovery questionnaire at 24 hours
Detailed description
This is a prospective, randomized, controlled, single-center clinical trial designed to evaluate the postoperative analgesic efficacy of the Quadroiliac Plane (QIP) block in patients undergoing femur fracture surgery, specifically partial hip arthroplasty under spinal anesthesia. The primary objective of the study is to assess the impact of the QIP block on total opioid consumption (fentanyl via PCA) during the first 24 hours postoperatively. Secondary objectives include evaluation of rescue analgesia needs, dermatomal spread of the block, incidence of motor block or complications, block feasibility and application time, patient satisfaction, and length of hospital stay.
Eligible participants aged 18 years or older who are scheduled for elective partial hip arthroplasty due to femoral neck fracture and meet inclusion criteria will be invited to participate. After obtaining written informed consent, patients will be randomly assigned to one of two groups using a computer-generated sequence and sealed envelope method. The intervention group will receive a QIP block postoperatively using 40 mL of 0.25% bupivacaine under ultrasound guidance. The control group will receive no regional block. Both groups will receive standard postoperative multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with fentanyl.
Pain will be assessed using the Numerical Rating Scale (NRS), which ranges from 0 (no pain) to 10 (worst imaginable pain), at rest and with movement at 0, 6, 12, and 24 hours postoperatively. Rescue analgesia (50 mg dexketoprofen IV over 20 minutes) will be administered if needed. The dermatomal spread of the block will be evaluated using an alcohol-based cold test at 2 hours postoperatively. At 24 hours, all patients will complete the Quality of Recovery-15 (QOR-15) questionnaire, which scores recovery from 0 (poor recovery) to 150 (excellent recovery).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QIP Block Group | Experimental | Procedure: QIP blockParticipants in this group will receive a Quadroiliac Plane (QIP) block using 40 mL of 0.25% bupivacaine under ultrasound guidance, applied postoperatively while in the prone position. The block will be performed only on the surgical side. All patients will also receive standard postoperative multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with fentanyl. |
| Control Group | No intervention | –Participants in this group will not receive a regional block. They will be managed with standard postoperative multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with fentanyl. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years and older
- Scheduled for partial hip arthroplasty due to femur fracture
- ASA physical status classification I to III
- No contraindications to regional anesthesia or study medications
- Capable of understanding and using patient-controlled analgesia (PCA)
Key exclusion criteria (7 listed)
- ASA classification IV or higher
- History of bleeding disorders or use of anticoagulant therapy
- Known allergy to local anesthetics
- Presence of neuropathic pain disorders
- Undergoing emergency surgery
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 |
|---|---|---|
| QIP blockThe Quadroiliac Plane (QIP) block is a novel ultrasound-guided fascial plane block. In this study, it will be performed postoperatively under spinal anesthesia in the prone position. A low-frequency convex transducer will be used to visualize the quadratus lumborum muscle at its attachment to the inner iliac crest. Using an in-plane technique with a 22G x 100 mm needle, 40 mL of 0.25% bupivacaine will be injected into the fascial plane beneath the quadratus lumborum muscle. The block will be performed unilaterally on the surgical side. The aim is to provide postoperative analgesia in patients undergoing femur fracture surgery. | Procedure or surgery | QIP Block Group |
Primary outcome
Total Opioid Consumption Within the First 24 Hours Postoperatively
Time frame: 24 hours postoperatively
The total amount of fentanyl (in micrograms) administered via intravenous patient-controlled analgesia (PCA) will be recorded during the first 24 hours after surgery. This will be used to assess the analgesic efficacy of the Quadroiliac Plane (QIP) block compared to standard care without a block.
5 secondary outcomes
Rescue Analgesia Requirement
Time frame: 24 hours
Pain Scores at Rest and on Movement
Time frame: 0,6,12 and 24 hours
Extent of Dermatomal Coverage Measured by Cold Sensation Response to Alcohol Swab at 2 Hours Post-QIP Block
Time frame: 2 hours postoperatively
Postoperative Recovery Quality
Time frame: 24 hours postoperatively
Block-Related Complications
Time frame: 24 hours
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 20 Nov 2025.
- Background: PubMed 39495169Turan EI, Baydemir AE, Sahin AS. Efficacy of the quadro-iliac plane block in postoperative pain management for proximal femoral nail surgeries. Minerva Anestesiol. 2025 Mar;91(3):221-223. doi: 10.23736/S0375-9393.24.18506-9. Epub 2024 Nov 4. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Engin ihsan Turan, Specialist principal investigator
Health Science University İstanbul Kanuni Sultan Süleyman Education 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 QIP block in people with Femur Fracture, 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 6 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: finished, as of the sponsor's last update on 20 Nov 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?
Total Opioid Consumption Within the First 24 Hours Postoperatively (time frame: 24 hours postoperatively). 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 NCT07009782, 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 20 Nov 2025.