Postoperative PainPhase 1NCT07787442
Postoperative Pain Management for Hip Surgeries: UltrasoundGuided Suprainguinal Fascia Iliaca Compartment Block Versus Suprainguinal Fascia Iliaca Compartment Block in Combination With Sciatic Nerve Block
A Phase 1 study testing Bupivacaine injection in people with Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the Study is to compare the analgesic efficacy and clinical outcomes of suprainguinal fascia iliaca block (SIFIB) alone versus SIFIB combined with sciatic nerve block (SNB) in patients undergoing hip surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Nov 2025to 2 Jun 2026
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 - 70 years old.
- Sex: Both sexes.
- American Society of Anesthesiologists (ASA) physical status I , II, III, IV.
- Hip surgeries e.g.: Total hip arthroplasty, Hemi-arthroplasty, Fracture neck of femur under spinal anesthesia
Who cannot join
- Refusal to participate.
- Known allergy to local anesthetics.
- Coagulopathy or anticoagulant therapy contraindicating regional anesthesia.
- Pre-existing neurological deficits in the lower limbs.
- Infection at the injection site.
- Severe cognitive impairment or inability to assess pain (e.g., advanced dementia).
- Failed spinal anesthesia.
- Body mass index (BMI) >40 kg / m²
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the Study is to compare the analgesic efficacy and clinical outcomes of suprainguinal fascia iliaca block (SIFIB) alone versus SIFIB combined with sciatic nerve block (SNB) in patients undergoing hip surgery.
Read the detailed description
The aim of the Study is to compare the analgesic efficacy and clinical outcomes of suprainguinal fascia iliaca block (SIFIB) alone versus SIFIB combined with sciatic nerve block (SNB) in patients undergoing hip surgery.
- Primary Objectives: Time for first rescue analgesia.
- Secondary Objectives:
- Numerical Rating Scale (NRS) scores at rest and during movement at 6 hours, 12 hours, 24 hours, and 48 hours after surgery.
- Total opioid consumption within the first 24 hours post-surgery.
- Postoperative incidence and severity of motor blockade in the affected limb associated with each block technique (measured using the Modified Bromage Scale).
- Technical difficulty and duration of administering each block.
- Conditions
- Postoperative Pain
- Being tested
- Bupivacaine injection
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine injectionDrug
Bupivacaine injection
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided Suprainguinal Fascia Iliaca Compartment Block | Active comparator | Not described Receives: Drug: Bupivacaine injection |
| Ultrasound Guided Suprainguinal Fascia Iliaca Compartment Block in combination with Sciatic Nerve Bl | Active comparator | Not described Receives: Drug: Bupivacaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for first rescue analgesia
Time to first request for rescue analgesia: Defined as the time interval from the end of procedure until the patient's first complaint of pain with a Numerical Rating Scale (NRS) score ≥ 4 and requests pain relief
Measured: Numerical Pain Score in PACU, 6 hrs, 12 hrs, 24 hrs and 48 hrs postoperative
Secondary outcomes (1)
Motor Block Assessment
Motor Block Assessment: Assessed using the Modified Bromage Scale (0 = no block; 1 = unable to raise extended leg; 2 = unable to flex knee; 3 = unable to move foot or knee) at 2, 6, 12, and 24 hours postoperatively
Measured: The Modified Bromage Scale at 2 , 6 , 12 and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start2 Nov 2025
- Primary completion2 May 2026
- Study completion2 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787442
- Sponsor's protocol ID
- FMASU MS 763/2025
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Management for Hip Surgeries: UltrasoundGuided Suprainguinal Fascia Iliaca Compartment Block Versus Suprainguinal Fascia Iliaca Compartment Block in Combination With Sciatic Nerve Block
- ClinicalTrials.gov ID
- NCT07787442
- Acronym / sponsor ID
- FMASU MS 763/2025
- Conditions
- Postoperative Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 Nov 2025 (actual)
- Primary completion
- 2 May 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 26 Aug 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.
The aim of the Study is to compare the analgesic efficacy and clinical outcomes of suprainguinal fascia iliaca block (SIFIB) alone versus SIFIB combined with sciatic nerve block (SNB) in patients undergoing hip surgery.
Detailed description
The aim of the Study is to compare the analgesic efficacy and clinical outcomes of suprainguinal fascia iliaca block (SIFIB) alone versus SIFIB combined with sciatic nerve block (SNB) in patients undergoing hip surgery.
- Primary Objectives: Time for first rescue analgesia.
- Secondary Objectives:
- Numerical Rating Scale (NRS) scores at rest and during movement at 6 hours, 12 hours, 24 hours, and 48 hours after surgery.
- Total opioid consumption within the first 24 hours post-surgery.
- Postoperative incidence and severity of motor blockade in the affected limb associated with each block technique (measured using the Modified Bromage Scale).
- Technical difficulty and duration of administering each block.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided Suprainguinal Fascia Iliaca Compartment Block | Active comparator | Drug: Bupivacaine injection |
| Ultrasound Guided Suprainguinal Fascia Iliaca Compartment Block in combination with Sciatic Nerve Bl | Active comparator | Drug: Bupivacaine injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18 - 70 years old.
Key exclusion criteria (8 listed)
- Refusal to participate.
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 |
|---|---|---|
| Bupivacaine injectionBupivacaine injection | Drug | Ultrasound Guided Suprainguinal Fascia Iliaca Compartment Block, Ultrasound Guided Suprainguinal Fascia Iliaca Compartment Block in combination with Sciatic Nerve Bl |
Primary outcome
Time for first rescue analgesia
Time frame: Numerical Pain Score in PACU, 6 hrs, 12 hrs, 24 hrs and 48 hrs postoperative
Time to first request for rescue analgesia: Defined as the time interval from the end of procedure until the patient's first complaint of pain with a Numerical Rating Scale (NRS) score ≥ 4 and requests pain relief
1 secondary outcome
Motor Block Assessment
Time frame: The Modified Bromage Scale at 2 , 6 , 12 and 24 hours postoperatively
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 26 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bupivacaine injection in people with Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
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 8 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 26 Aug 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 Egypt. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time for first rescue analgesia (time frame: Numerical Pain Score in PACU, 6 hrs, 12 hrs, 24 hrs and 48 hrs postoperative). 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 26 Aug 2026.