Hip FractureHIP-3BNCT07676734
Comparison of Three Analgesic Strategies for Hip Fracture Surgery
A study testing Quadro-Iliac Plane Block, Suprainguinal Fascia Iliaca Block and Standard Multimodal Analgesia in people with Hip Fracture, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Hip fracture surgery is associated with significant postoperative pain and increased opioid requirements. Regional anesthesia techniques may improve analgesia and reduce opioid consumption. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Quadro-Iliac Plane Block, Suprainguinal Fascia Iliaca Block and Standard Multimodal Analgesia
- 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
- 15 Jul 2026to Feb 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or older
- Patients scheduled for hip fracture surgery under spinal anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Provision of written informed consent
Who cannot join
- Refusal to participate
- Contraindications to spinal anesthesia
- Contraindications to regional anesthesia
- Allergy to local anesthetics or study medications
- Infection at the injection site
- Coagulopathy or anticoagulant therapy precluding regional block
Show all 9Show fewer
- Cognitive impairment preventing pain assessment
- Chronic opioid use
- Revision surgery
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
Başakşehir Çam and Sakura City Hospital
Istanbul, Istanbul
About this study
Official title: Comparison of the Postoperative Analgesic Efficacy of Quadro-Iliac Plane Block, Suprainguinal Fascia Iliaca Block, and Standard Analgesia Protocol in Patients Undergoing Hip Fracture Surgery Under Spinal Anesthesia: A Prospective, Randomized, Double-Blind, Controlled Trial
Hip fracture surgery is associated with significant postoperative pain and increased opioid requirements. Regional anesthesia techniques may improve analgesia and reduce opioid consumption. This prospective, randomized, double-blind, controlled trial aims to compare the postoperative analgesic efficacy of Quadro-Iliac Plane Block (QIPB), Suprainguinal Fascia Iliaca Block (SIFIB), and standard analgesia in patients undergoing hip fracture surgery under spinal anesthesia. The primary outcome is cumulative tramadol consumption during the first 24 postoperative hours. Secondary outcome measures include postoperative pain intensity, rescue analgesic requirement, incidence of postoperative nausea and vomiting, Quality of Recovery-15 (QoR-15) score, and patient satisfaction score.
Read the detailed description
Hip fracture surgery is frequently associated with severe postoperative pain, delayed mobilization, and increased opioid consumption. Regional anesthesia techniques have been increasingly used to improve postoperative analgesia and reduce opioid-related adverse effects.
This prospective, randomized, double-blind, controlled, multicenter study aims to compare the postoperative analgesic efficacy of Quadro-Iliac Plane Block (QIPB), Suprainguinal Fascia Iliaca Block (SIFIB), and standard analgesia in patients undergoing hip fracture surgery under spinal anesthesia. Patients will be randomly allocated in a 1:1:1 ratio to one of the three study groups.
All surgical procedures will be performed under spinal anesthesia. Patients assigned to the QIPB group will receive ultrasound-guided quadro-iliac plane block, whereas patients assigned to the SIFIB group will receive ultrasound-guided suprainguinal fascia iliaca block. Patients in the control group will receive standard multimodal analgesia without a regional block.
The primary outcome measure is cumulative tramadol consumption during the first 24 postoperative hours. Secondary outcomes include postoperative pain scores, rescue analgesic requirements, time to first rescue analgesia, postoperative nausea and vomiting, quality of recovery assessed with the Quality of Recovery-15 (QoR-15) questionnaire, patient satisfaction, intraoperative opioid consumption, and block-related complications.
The study is planned to enroll 90 patients across three centers.
- Conditions
- Hip Fracture
- Being tested
- Quadro-Iliac Plane Block, Suprainguinal Fascia Iliaca Block, Standard Multimodal Analgesia
- Keywords
- Quadro-Iliac Plane Block, Suprainguinal Fascia Iliaca Block, Regional Anesthesia, Postoperative Analgesia, Spinal Anesthesia, Tramadol Consumption, QoR-15, Hip Fracture Surgery
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadro-Iliac Plane BlockProcedure or surgery
Ultrasound-guided quadro-iliac plane block will be performed following spinal anesthesia in patients undergoing hip fracture surgery. The block will be administered in addition to standard multimodal analgesia.
Suprainguinal Fascia Iliaca BlockProcedure or surgery
Ultrasound-guided suprainguinal fascia iliaca block will be performed following spinal anesthesia in patients undergoing hip fracture surgery. The block will be administered in addition to standard multimodal analgesia.
Standard Multimodal AnalgesiaOther
Patients assigned to the control group will receive standard multimodal analgesia without a regional block following hip fracture surgery performed under spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Quadro-Iliac Plane Block Group | Experimental | Patients assigned to this group will receive ultrasound-guided quadro-iliac plane block in addition to standard multimodal analgesia following hip fracture surgery performed under spinal anesthesia. Receives: Procedure: Quadro-Iliac Plane Block |
| Suprainguinal Fascia Iliaca Block Group | Experimental | Patients assigned to this group will receive ultrasound-guided suprainguinal fascia iliaca block in addition to standard multimodal analgesia following hip fracture surgery performed under spinal anesthesia. Receives: Procedure: Suprainguinal Fascia Iliaca Block |
| Standard Analgesia Group | Active comparator | Patients assigned to this group will receive standard multimodal analgesia without a regional block following hip fracture surgery performed under spinal anesthesia. Receives: Other: Standard Multimodal Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Tramadol Consumption During the First 24 Postoperative Hours
The total amount of tramadol administered during the first 24 postoperative hours will be recorded and compared among the study groups.
Measured: 24 hours after surgery
Secondary outcomes (7)
Postoperative Pain Intensity at Rest
Postoperative pain intensity at rest will be assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: At 0, 2, 6, 12, and 24 hours after surgery
Time to First Rescue Analgesia
Time from completion of surgery to the first administration of rescue analgesia, measured in hours.
Measured: Within the first 24 hours after surgery
Rescue Analgesic Requirement
The proportion of patients requiring rescue analgesia during the first 24 hours after surgery.
Measured: Within the first 24 hours after surgery
Incidence of Postoperative Nausea and Vomiting
The incidence of postoperative nausea and/or vomiting during the first 24 hours after surgery will be recorded.
Measured: Within the first 24 hours after surgery
Quality of Recovery-15 (QoR-15) Score
Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire. The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery.
Measured: 24 hours after surgery
Patient Satisfaction Score
Patient satisfaction with postoperative pain management will be assessed using a numerical rating scale scored between 0 and 10 at postoperative 24 hours (0 = not satisfied at all, 10 = completely satisfied). Higher scores indicate greater patient satisfaction.
Measured: 24 hours after surgery
Block-related Complications
The incidence of block-related complications, including local anesthetic systemic toxicity, vascular puncture, hematoma, infection, and persistent sensory or motor deficits, will be recorded.
Measured: During the first 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start15 Jul 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip 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
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to receive quadro-iliac plane block, suprainguinal fascia iliaca block, or standard analgesia.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kenan Kart, Principal investigator, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676734
- Sponsor's protocol ID
- HIP-QIPB-SIFIB-2026
- Other IDs
- 105
- Acronym
- HIP-3B
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data will not be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Postoperative Analgesic Efficacy of Quadro-Iliac Plane Block, Suprainguinal Fascia Iliaca Block, and Standard Analgesia Protocol in Patients Undergoing Hip Fracture Surgery Under Spinal Anesthesia: A Prospective, Randomized, Double-Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT07676734
- Acronym / sponsor ID
- HIP-3B / HIP-QIPB-SIFIB-2026
- Conditions
- Hip Fracture
- Keywords
- Quadro-Iliac Plane Block, Suprainguinal Fascia Iliaca Block, Regional Anesthesia, Postoperative Analgesia, Spinal Anesthesia, Tramadol Consumption, QoR-15, Hip Fracture Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 30 Jun 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.
Hip fracture surgery is associated with significant postoperative pain and increased opioid requirements. Regional anesthesia techniques may improve analgesia and reduce opioid consumption. This prospective, randomized, double-blind, controlled trial aims to compare the postoperative analgesic efficacy of Quadro-Iliac Plane Block (QIPB), Suprainguinal Fascia Iliaca Block (SIFIB), and standard analgesia in patients undergoing hip fracture surgery under spinal anesthesia. The primary outcome is cumulative tramadol consumption during the first 24 postoperative hours. Secondary outcome measures include postoperative pain intensity, rescue analgesic requirement, incidence of postoperative nausea and vomiting, Quality of Recovery-15 (QoR-15) score, and patient satisfaction score.
Detailed description
Hip fracture surgery is frequently associated with severe postoperative pain, delayed mobilization, and increased opioid consumption. Regional anesthesia techniques have been increasingly used to improve postoperative analgesia and reduce opioid-related adverse effects.
This prospective, randomized, double-blind, controlled, multicenter study aims to compare the postoperative analgesic efficacy of Quadro-Iliac Plane Block (QIPB), Suprainguinal Fascia Iliaca Block (SIFIB), and standard analgesia in patients undergoing hip fracture surgery under spinal anesthesia. Patients will be randomly allocated in a 1:1:1 ratio to one of the three study groups.
All surgical procedures will be performed under spinal anesthesia. Patients assigned to the QIPB group will receive ultrasound-guided quadro-iliac plane block, whereas patients assigned to the SIFIB group will receive ultrasound-guided suprainguinal fascia iliaca block. Patients in the control group will receive standard multimodal analgesia without a regional block.
The primary outcome measure is cumulative tramadol consumption during the first 24 postoperative hours. Secondary outcomes include postoperative pain scores, rescue analgesic requirements, time to first rescue analgesia, postoperative nausea and vomiting, quality of recovery assessed with the Quality of Recovery-15 (QoR-15) questionnaire, patient satisfaction, intraoperative opioid consumption, and block-related complications.
The study is planned to enroll 90 patients across three centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to receive quadro-iliac plane block, suprainguinal fascia iliaca block, or standard analgesia.
| Arm | Type | Receives |
|---|---|---|
| Quadro-Iliac Plane Block Group | Experimental | Procedure: Quadro-Iliac Plane BlockPatients assigned to this group will receive ultrasound-guided quadro-iliac plane block in addition to standard multimodal analgesia following hip fracture surgery performed under spinal anesthesia. |
| Suprainguinal Fascia Iliaca Block Group | Experimental | Procedure: Suprainguinal Fascia Iliaca BlockPatients assigned to this group will receive ultrasound-guided suprainguinal fascia iliaca block in addition to standard multimodal analgesia following hip fracture surgery performed under spinal anesthesia. |
| Standard Analgesia Group | Active comparator | Other: Standard Multimodal AnalgesiaPatients assigned to this group will receive standard multimodal analgesia without a regional block following hip fracture surgery performed under spinal anesthesia. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 18 years or older
- Patients scheduled for hip fracture surgery under spinal anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Provision of written informed consent
Key exclusion criteria (9 listed)
- Refusal to participate
- Contraindications to spinal anesthesia
- Contraindications to regional anesthesia
- Allergy to local anesthetics or study medications
- Infection at the injection site
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 |
|---|---|---|
| Quadro-Iliac Plane BlockUltrasound-guided quadro-iliac plane block will be performed following spinal anesthesia in patients undergoing hip fracture surgery. The block will be administered in addition to standard multimodal analgesia. | Procedure or surgery | Quadro-Iliac Plane Block Group |
| Suprainguinal Fascia Iliaca BlockUltrasound-guided suprainguinal fascia iliaca block will be performed following spinal anesthesia in patients undergoing hip fracture surgery. The block will be administered in addition to standard multimodal analgesia. | Procedure or surgery | Suprainguinal Fascia Iliaca Block Group |
| Standard Multimodal AnalgesiaPatients assigned to the control group will receive standard multimodal analgesia without a regional block following hip fracture surgery performed under spinal anesthesia. | Other | Standard Analgesia Group |
Primary outcome
Cumulative Tramadol Consumption During the First 24 Postoperative Hours
Time frame: 24 hours after surgery
The total amount of tramadol administered during the first 24 postoperative hours will be recorded and compared among the study groups.
7 secondary outcomes
Postoperative Pain Intensity at Rest
Time frame: At 0, 2, 6, 12, and 24 hours after surgery
Time to First Rescue Analgesia
Time frame: Within the first 24 hours after surgery
Rescue Analgesic Requirement
Time frame: Within the first 24 hours after surgery
Incidence of Postoperative Nausea and Vomiting
Time frame: Within the first 24 hours after surgery
Quality of Recovery-15 (QoR-15) Score
Time frame: 24 hours after surgery
Patient Satisfaction Score
Time frame: 24 hours after surgery
Block-related Complications
Time frame: During the first 24 hours after surgery.
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 Jun 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be made publicly available.
Related trials for Hip Fracture
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
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.
Kenan Kart principal investigator
Karabuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadro-Iliac Plane Block, Suprainguinal Fascia Iliaca Block and Standard Multimodal Analgesia in people with Hip Fracture, run by Başakşehir Çam & Sakura 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 30 Jun 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 muzaffer Gencer (+905059436459, dr.m.gencer07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Tramadol Consumption During the First 24 Postoperative Hours (time frame: 24 hours after surgery). 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 Jun 2026.