Post Operative PainNCT07546903
Comparison of Analgesic Efficacy of Suprainguinal Fascia Iliaca and Quadro-iliac Blocks in Hip Fracture Surgery
A study testing Suprainguinal Fascia Iliaca Block and Quadro-Iliac Plane Block in people with Post Operative Pain, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, double-masked trial compared two ultrasound-guided regional analgesic techniques, suprainguinal fascia iliaca block (SIFI) and quadro-iliac plane block (QIPB), in adults undergoing surgery for hip fracture under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Suprainguinal Fascia Iliaca Block and Quadro-Iliac Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2026to 13 Sep 2026
- 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
- Scheduled for surgical treatment of hip fracture
- Age 18 years or older
- ASA physical status I-III
- Hemodynamically stable
- Conscious and able to communicate verbally
- Body mass index (BMI) ≤35 kg/m²
- Provided written informed consent
Who cannot join
- Refusal to participate
- ASA physical status IV-V or hemodynamic instability
- Infection at the block site
- Allergy to local anesthetics or tramadol
- Neuromuscular or peripheral nerve disease
- Chronic pain
Show all 20Show fewer
- Coagulopathy or anticoagulant treatment
- High-dose opioid use within the preceding three days
- Severe hepatic or renal insufficiency
- Diabetes mellitus
- Pregnancy or breastfeeding
- Inability to understand or respond to NRS or QoR-15 assessments
- Inability to communicate in Turkish
- Previous hip surgery
- Criteria for withdrawal after enrollment:
- Surgery not completed as planned or terminated before completion
- NRS >7 for four consecutive hours despite the planned multimodal analgesia regimen
- Inability to perform postoperative NRS assessments
- Inability to use patient-controlled analgesia because of technical problems
- Postoperative hemodynamic deterioration or other health problems preventing completion of follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Postoperative Analgesic Efficacy of Ultrasound-Guided Suprainguinal Fascia Iliaca Block and Quadro-Iliac Plane Block in Patients Undergoing Hip Fracture Surgery
This prospective, randomized, double-masked trial compared two ultrasound-guided regional analgesic techniques, suprainguinal fascia iliaca block (SIFI) and quadro-iliac plane block (QIPB), in adults undergoing surgery for hip fracture under spinal anesthesia. The primary outcome was total opioid consumption, expressed as approximate intravenous morphine equivalents, during the first 24 hours after complete resolution of spinal motor block (Bromage score 0). Secondary outcomes included pain at rest and during movement assessed using a 0-10 numeric rating scale, rescue analgesic requirements, nausea and vomiting, quality of recovery, time to first assisted standing and other recovery measures, and patient satisfaction. Both groups received the same postoperative multimodal analgesic regimen. Eighty-five participants were randomized, and 70 participants completed follow-up and were included in the reported analysis.
Read the detailed description
This prospective, parallel-group randomized trial compared two ultrasound-guided blocks in adults undergoing hip fracture surgery under spinal anesthesia. Participants and postoperative outcome assessors were masked; the anesthesiologist performing the block knew the assigned technique. Eighty-five participants were randomized (43 SIFI and 42 QIPB), and 35 per group were included in the reported analysis after post-randomization exclusions. Different surgical procedures for hip fracture were included; procedure type was not used for subgroup analysis.
Both blocks were performed before spinal anesthesia using a linear ultrasound probe and an 80-mm peripheral block needle. SIFI was performed supine, with injection deep to fascia iliaca over the iliacus muscle and suprainguinal spread. QIPB targeted the fascial plane related to the posterior surface of quadratus lumborum at its attachment to the iliac crest. QIPB was performed prone, or in lateral decubitus when pain prevented tolerance of prone positioning. Both blocks used 40 mL of 0.25% bupivacaine (100 mg). The peripheral block dose limit was 2 mg/kg; no dose reduction was required. Spinal anesthesia used 12.5 mg of 0.5% hyperbaric bupivacaine.
Both groups received intravenous paracetamol 1 g every eight hours and tramadol patient-controlled analgesia (10-mg bolus, 20-minute lockout, no background infusion, maximum 400 mg per day). Rescue analgesia was 25 micrograms of intravenous fentanyl if either rest or movement pain exceeded 4 on the numeric rating scale. Rescue doses were recorded separately from patient-controlled analgesia button presses. Pain was reassessed at the next scheduled assessment, with further rescue analgesia when required.
Time zero was complete resolution of spinal motor block (Bromage score 0). Rest and movement pain were assessed at 0, 1, 3, 6, 12, 18 and 24 hours from time zero. Movement was defined as changing from a lying to a sitting position. Opioid consumption and rescue analgesia were assessed within the same 24-hour window. Tramadol and fentanyl doses were recorded separately and summarized as approximate intravenous morphine equivalents. The Turkish QoR-15 was administered before surgery and 24 hours after time zero; higher scores indicate better recovery. First assisted standing, first oral intake and first passage of either flatus or stool were timed from time zero. Satisfaction was rated from 1 to 10.
The first participant was enrolled on May 4, 2026. Final primary outcome assessments and all study follow-up were completed on September 13, 2026.
The difference in outcome priority between the protocol and the initial registry version was reconciled after study completion by adopting the protocol hierarchy.
- Conditions
- Post Operative Pain
- Being tested
- Suprainguinal Fascia Iliaca Block, Quadro-Iliac Plane Block
- Keywords
- Hip Fracture, Suprainguinal Fascia Iliaca Block, Quadro-Iliac Plane Block
- Medical subject headings
- Pain, Postoperative, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprainguinal Fascia Iliaca BlockProcedure or surgery
the area between the iliacus muscle and the fascia iliaca will be reached at the level of the anterior superior iliac spine, proximal to the inguinal ligament. Hydrodissection will be performed with 2 mL of saline, followed by the injection of 40 mL of 0.25% bupivacaine.
Quadro-Iliac Plane BlockProcedure or surgery
Ultrasound-guided injection of 40 mL 0.25% bupivacaine (100 mg) into the fascial plane related to the posterior surface of quadratus lumborum at its attachment to the iliac crest, before spinal anesthesia. A linear probe and an 80-mm peripheral block needle were used. Patients were prone or, when pain prevented tolerance of prone positioning, in lateral decubitus.
| Study group | Role | What they receive |
|---|---|---|
| Suprainguinal Fascia Iliaca Block (Group S) | Active comparator | Before spinal anesthesia, participants received ultrasound-guided suprainguinal fascia iliaca block in the supine position. A sterile-covered linear probe and an 80-mm peripheral block needle were used. The needle was advanced in-plane to the space deep to fascia iliaca and superficial to iliacus, proximal to the inguinal ligament. After hydrodissection with 2 mL saline, 40 mL of 0.25% bupivacaine (100 mg) was injected while observing spread in the fascial plane. Both groups received the same spinal anesthesia and postoperative multimodal analgesic regimen. Receives: Procedure: Suprainguinal Fascia Iliaca Block |
| Quadro-Iliac Plane Block (Group Q) | Experimental | Before spinal anesthesia, participants received ultrasound-guided quadro-iliac plane block. The patient was prone, or in lateral decubitus when pain prevented tolerance of the prone position. A sterile-covered linear probe and an 80-mm peripheral block needle were used. Ultrasound orientation identified quadratus lumborum and its attachment to the iliac crest. The needle targeted the fascial plane related to the posterior surface of quadratus lumborum at this level. After hydrodissection, 40 mL of 0.25% bupivacaine (100 mg) was injected with ultrasound observation of fascial plane spread. Both groups received the same spinal anesthesia and postoperative multimodal analgesic regimen. Receives: Procedure: Quadro-Iliac Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption during the first 24 hours after Bromage score 0
Total tramadol delivered by intravenous patient-controlled analgesia and intravenous fentanyl administered as rescue analgesia were recorded separately. Approximate intravenous morphine equivalents (mg) were calculated as 0.1 × tramadol (mg) + fentanyl (micrograms)/15. Premedication fentanyl was excluded.
Measured: First 24 hours after complete resolution of spinal motor block (Bromage score 0)
Secondary outcomes (9)
Pain at rest and during movement assessed by the Numeric Rating Scale (NRS)
Rest and movement pain were assessed separately using an 11-point numeric rating scale: 0 indicates no pain and 10 the worst imaginable pain. Movement was defined as changing from a lying to a sitting position. Time zero was complete resolution of spinal motor block (Bromage score 0). Both pain series during the first 24 hours were secondary outcomes.
Measured: 0, 1, 3, 6, 12, 18 and 24 hours after complete resolution of spinal motor block (Bromage score 0)
Rescue analgesia requirement
Number of participants receiving at least one rescue analgesic dose. Rescue analgesia was 25 micrograms intravenous fentanyl when either rest or movement NRS exceeded 4. Patient-controlled analgesia button presses were not classified as rescue analgesia.
Measured: First 24 hours after Bromage score 0
Time to first rescue analgesia
Time in minutes from Bromage score 0 to the first intravenous rescue fentanyl administration. Participants without rescue analgesia were censored at 24 hours for time-to-event analysis.
Measured: Up to 24 hours after Bromage score 0
Postoperative nausea and vomiting
Nausea and vomiting were scored at each assessment on the study scale: 1, no nausea or vomiting; 2, nausea without vomiting; 3, one episode of vomiting or persistent nausea; 4, two or more vomiting episodes within four hours. Higher scores indicate worse symptoms. Ondansetron use and total dose were also recorded.
Measured: 0, 1, 3, 6, 12, 18 and 24 hours after Bromage score 0
Quality of recovery assessed by QoR-15
The Turkish Quality of Recovery-15 questionnaire was administered before and after surgery. Total scores range from 0 to 150, with higher scores indicating better recovery. The A section contains the first 10 positive items (0-100); the B section contains the last five negative symptom items (0-50), scored so that higher values mean fewer symptoms.
Measured: Preoperatively on the morning of surgery and 24 hours after Bromage score 0
Time to first assisted standing
Time in hours from Bromage score 0 until the participant first stood with assistance. Follow-up continued to the first event even when it occurred after 24 hours.
Measured: From complete resolution of spinal motor block (Bromage score 0) until first assisted standing during postoperative inpatient follow-up, an average of approximately 26 hours among assessed participants.
Time to first oral intake
Time in hours from complete resolution of spinal motor block (Bromage score 0) to first oral intake during the following 24 hours.
Measured: First 24 hours after complete resolution of spinal motor block (Bromage score 0)
First passage of flatus or stool
Time in hours from complete resolution of spinal motor block (Bromage score 0) to whichever occurred first: passage of flatus or stool, during the following 24 hours. Participants without an event were observed for the full 24-hour period and classified as having no event within 24 hours. Event times were not assigned a zero duration.
Measured: First 24 hours after complete resolution of spinal motor block (Bromage score 0)
Patient satisfaction
At 24 hours after complete resolution of spinal motor block (Bromage score 0), participants rated satisfaction with the treatment from 1 to 10. Higher scores indicate greater satisfaction.
Measured: 24 hours after complete resolution of spinal motor block (Bromage score 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start4 May 2026
- Primary completion13 Sep 2026
- Study completion13 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Prospective, two-arm, parallel-group randomized trial comparing ultrasound-guided suprainguinal fascia iliaca block with quadro-iliac plane block in patients undergoing hip fracture surgery under spinal anesthesia. Allocation was planned in a 1:1 ratio. Eighty-five participants were randomized; 70 participants (35 per group) completed follow-up and were included in the reported analysis.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed ATICI, Hitit University
- Investigators
- Ozgur Yagan, Proffesor, Study chair, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546903
- Sponsor's protocol ID
- 2025-161
- Status last verified
- Oct 2026
- First submitted
- 10 Apr 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our regulations forbid to share the IPD
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Postoperative Analgesic Efficacy of Ultrasound-Guided Suprainguinal Fascia Iliaca Block and Quadro-Iliac Plane Block in Patients Undergoing Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT07546903
- Acronym / sponsor ID
- 2025-161
- Conditions
- Post Operative Pain
- Keywords
- Hip Fracture, Suprainguinal Fascia Iliaca Block, Quadro-Iliac Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- 13 Sep 2026 (actual)
- Study completion
- 13 Sep 2026 (actual)
- First posted
- 23 Apr 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 prospective, randomized, double-masked trial compared two ultrasound-guided regional analgesic techniques, suprainguinal fascia iliaca block (SIFI) and quadro-iliac plane block (QIPB), in adults undergoing surgery for hip fracture under spinal anesthesia. The primary outcome was total opioid consumption, expressed as approximate intravenous morphine equivalents, during the first 24 hours after complete resolution of spinal motor block (Bromage score 0). Secondary outcomes included pain at rest and during movement assessed using a 0-10 numeric rating scale, rescue analgesic requirements, nausea and vomiting, quality of recovery, time to first assisted standing and other recovery measures, and patient satisfaction. Both groups received the same postoperative multimodal analgesic regimen. Eighty-five participants were randomized, and 70 participants completed follow-up and were included in the reported analysis.
Detailed description
This prospective, parallel-group randomized trial compared two ultrasound-guided blocks in adults undergoing hip fracture surgery under spinal anesthesia. Participants and postoperative outcome assessors were masked; the anesthesiologist performing the block knew the assigned technique. Eighty-five participants were randomized (43 SIFI and 42 QIPB), and 35 per group were included in the reported analysis after post-randomization exclusions. Different surgical procedures for hip fracture were included; procedure type was not used for subgroup analysis.
Both blocks were performed before spinal anesthesia using a linear ultrasound probe and an 80-mm peripheral block needle. SIFI was performed supine, with injection deep to fascia iliaca over the iliacus muscle and suprainguinal spread. QIPB targeted the fascial plane related to the posterior surface of quadratus lumborum at its attachment to the iliac crest. QIPB was performed prone, or in lateral decubitus when pain prevented tolerance of prone positioning. Both blocks used 40 mL of 0.25% bupivacaine (100 mg). The peripheral block dose limit was 2 mg/kg; no dose reduction was required. Spinal anesthesia used 12.5 mg of 0.5% hyperbaric bupivacaine.
Both groups received intravenous paracetamol 1 g every eight hours and tramadol patient-controlled analgesia (10-mg bolus, 20-minute lockout, no background infusion, maximum 400 mg per day). Rescue analgesia was 25 micrograms of intravenous fentanyl if either rest or movement pain exceeded 4 on the numeric rating scale. Rescue doses were recorded separately from patient-controlled analgesia button presses. Pain was reassessed at the next scheduled assessment, with further rescue analgesia when required.
Time zero was complete resolution of spinal motor block (Bromage score 0). Rest and movement pain were assessed at 0, 1, 3, 6, 12, 18 and 24 hours from time zero. Movement was defined as changing from a lying to a sitting position. Opioid consumption and rescue analgesia were assessed within the same 24-hour window. Tramadol and fentanyl doses were recorded separately and summarized as approximate intravenous morphine equivalents. The Turkish QoR-15 was administered before surgery and 24 hours after time zero; higher scores indicate better recovery. First assisted standing, first oral intake and first passage of either flatus or stool were timed from time zero. Satisfaction was rated from 1 to 10.
The first participant was enrolled on May 4, 2026. Final primary outcome assessments and all study follow-up were completed on September 13, 2026.
The difference in outcome priority between the protocol and the initial registry version was reconciled after study completion by adopting the protocol hierarchy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, two-arm, parallel-group randomized trial comparing ultrasound-guided suprainguinal fascia iliaca block with quadro-iliac plane block in patients undergoing hip fracture surgery under spinal anesthesia. Allocation was planned in a 1:1 ratio. Eighty-five participants were randomized; 70 participants (35 per group) completed follow-up and were included in the reported analysis.
| Arm | Type | Receives |
|---|---|---|
| Suprainguinal Fascia Iliaca Block (Group S) | Active comparator | Procedure: Suprainguinal Fascia Iliaca BlockBefore spinal anesthesia, participants received ultrasound-guided suprainguinal fascia iliaca block in the supine position. A sterile-covered linear probe and an 80-mm peripheral block needle were used. The needle was advanced in-plane to the space deep to fascia iliaca and superficial to iliacus, proximal to the inguinal ligament. After hydrodissection with 2 mL saline, 40 mL of 0.25% bupivacaine (100 mg) was injected while observing spread in the fascial plane. Both groups received the same spinal anesthesia and postoperative multimodal analgesic regimen. |
| Quadro-Iliac Plane Block (Group Q) | Experimental | Procedure: Quadro-Iliac Plane BlockBefore spinal anesthesia, participants received ultrasound-guided quadro-iliac plane block. The patient was prone, or in lateral decubitus when pain prevented tolerance of the prone position. A sterile-covered linear probe and an 80-mm peripheral block needle were used. Ultrasound orientation identified quadratus lumborum and its attachment to the iliac crest. The needle targeted the fascial plane related to the posterior surface of quadratus lumborum at this level. After hydrodissection, 40 mL of 0.25% bupivacaine (100 mg) was injected with ultrasound observation of fascial plane spread. Both groups received the same spinal anesthesia and postoperative multimodal analgesic regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Scheduled for surgical treatment of hip fracture
- Age 18 years or older
- ASA physical status I-III
- Hemodynamically stable
- Conscious and able to communicate verbally
Key exclusion criteria (20 listed)
- Refusal to participate
- ASA physical status IV-V or hemodynamic instability
- Infection at the block site
- Allergy to local anesthetics or tramadol
- Neuromuscular or peripheral nerve disease
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 |
|---|---|---|
| Suprainguinal Fascia Iliaca Blockthe area between the iliacus muscle and the fascia iliaca will be reached at the level of the anterior superior iliac spine, proximal to the inguinal ligament. Hydrodissection will be performed with 2 mL of saline, followed by the injection of 40 mL of 0.25% bupivacaine. | Procedure or surgery | Suprainguinal Fascia Iliaca Block (Group S) |
| Quadro-Iliac Plane BlockUltrasound-guided injection of 40 mL 0.25% bupivacaine (100 mg) into the fascial plane related to the posterior surface of quadratus lumborum at its attachment to the iliac crest, before spinal anesthesia. A linear probe and an 80-mm peripheral block needle were used. Patients were prone or, when pain prevented tolerance of prone positioning, in lateral decubitus. | Procedure or surgery | Quadro-Iliac Plane Block (Group Q) |
Primary outcome
Total opioid consumption during the first 24 hours after Bromage score 0
Time frame: First 24 hours after complete resolution of spinal motor block (Bromage score 0)
Total tramadol delivered by intravenous patient-controlled analgesia and intravenous fentanyl administered as rescue analgesia were recorded separately. Approximate intravenous morphine equivalents (mg) were calculated as 0.1 × tramadol (mg) + fentanyl (micrograms)/15. Premedication fentanyl was excluded.
9 secondary outcomes
Pain at rest and during movement assessed by the Numeric Rating Scale (NRS)
Time frame: 0, 1, 3, 6, 12, 18 and 24 hours after complete resolution of spinal motor block (Bromage score 0)
Rescue analgesia requirement
Time frame: First 24 hours after Bromage score 0
Time to first rescue analgesia
Time frame: Up to 24 hours after Bromage score 0
Postoperative nausea and vomiting
Time frame: 0, 1, 3, 6, 12, 18 and 24 hours after Bromage score 0
Quality of recovery assessed by QoR-15
Time frame: Preoperatively on the morning of surgery and 24 hours after Bromage score 0
Time to first assisted standing
Time frame: From complete resolution of spinal motor block (Bromage score 0) until first assisted standing during postoperative inpatient follow-up, an average of approximately 26 hours among assessed participants.
Time to first oral intake
Time frame: First 24 hours after complete resolution of spinal motor block (Bromage score 0)
First passage of flatus or stool
Time frame: First 24 hours after complete resolution of spinal motor block (Bromage score 0)
Patient satisfaction
Time frame: 24 hours after complete resolution of spinal motor block (Bromage score 0)
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 4 Nov 2026.
- Individual participant dataSharing planned: No. Our regulations forbid to share the IPD
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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.
Ozgur Yagan, Proffesor study chair
Hitit 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 Suprainguinal Fascia Iliaca Block and Quadro-Iliac Plane Block in people with Post Operative Pain, run by Hitit University 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 7 inclusion and 20 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 4 Nov 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?
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 during the first 24 hours after Bromage score 0 (time frame: First 24 hours after complete resolution of spinal motor block (Bromage score 0)). 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 4 Nov 2026.