Analgesia After Fracture Femur SurgeriesNCT06990958
Comparing Erector Spinae and Fascia Iliaca Blocks for Pain Relief After Femur Surgery.
A study testing Erector Spinae Plane Block (ESPB) group and Fascia iliaca compartment block (FICB) in people with Analgesia After Fracture Femur Surgeries, run by Cairo University at 1 site in Egypt.
Trial summary
This clinical study compares two types of nerve blocks used to control pain in adult patients undergoing surgery on the upper (proximal) or middle (midshaft) part of the femur (thigh bone). The two blocks being studied are the Erector Spinae Plane (ESP) block and the Fascia Iliaca Compartment (FIC) block. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia After Fracture Femur Surgeries
- What is being tested?
- Erector Spinae Plane Block (ESPB) group and Fascia iliaca compartment block (FICB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Mar 2025to 10 Aug 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-80
- American society of Anathesiologist physical status ASA Ior II
- Patients undergoing Fixation of femur fractures
Who cannot join
- Refusal of participation in study.
- Bleeding disorders (platelets count \< 80,000, INR \>1.5, Prothrombin concentration \< 60%).
- Skin lesion, wounds or infection at the puncture site. Known allergy to local anesthetic drugs.
- Known local anesthetic (LA) drug sensitivity. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block Versus Fascia Iliaca Compartment Block for Analgesia in Proximal and Midshaft Femur Surgeries in Adult Patients: A Randomized Controlled Study
This clinical study compares two types of nerve blocks used to control pain in adult patients undergoing surgery on the upper (proximal) or middle (midshaft) part of the femur (thigh bone). The two blocks being studied are the Erector Spinae Plane (ESP) block and the Fascia Iliaca Compartment (FIC) block. Both techniques are commonly used in hospitals to reduce postoperative pain.
The goal is to determine which nerve block provides more effective pain relief, reduces the need for opioid medications, and supports faster recovery in patients following femur surgery. Results from this study may improve pain management strategies for similar procedures in the future.
Read more
Adults scheduled for proximal or midshaft femur surgery may be eligible to participate. Eligibility is determined based on clinical criteria reviewed by the study team.Administration of one of the two nerve blocks before surgery.Standard surgical and postoperative care.
Monitoring of pain levels at specific time points after surgery
Recording of opioid medication usage
Evaluation of patient satisfaction and any side effects related to the nerve block
Duration:
The intervention (nerve block) is administered once before surgery. Data collection continues during the immediate postoperative period and for a short time following surgery to assess outcomes.
Both nerve blocks are considered safe and are regularly used in clinical practice.
All procedures are performed by qualified clinicians, and safety monitoring is conducted throughout the study.
Participants may experience improved pain relief and reduced need for opioid medications. While direct benefit cannot be guaranteed, information gained from the study may help improve pain management for future patients undergoing similar surgeries.
Participation in the study is completely voluntary. Patients may choose not to participate or may withdraw from the study at any time without affecting the quality of their medical care.
- Conditions
- Analgesia After Fracture Femur Surgeries
- Being tested
- Erector Spinae Plane Block (ESPB) group, Fascia iliaca compartment block (FICB)
- Keywords
- Fascia iliac block, erector spinae block, femur fracture, adult analgesia
- Medical subject headings
- Femoral Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane Block (ESPB) groupProcedure or surgery
ultrasound guided erector spinae plane block (at lumbar level) in lateral position .
Fascia iliaca compartment block (FICB)Procedure or surgery
ultrasound guided suprainguinal approach in supine position
| Study group | Role | What they receive |
|---|---|---|
| ESPB Group | Active comparator | patients was placed in the lateral position . the block was performed bz ipsilateral injection of a mixture containing 15mls bupivcaine 0,5% and 20mls normal saline. Receives: Procedure: Erector Spinae Plane Block (ESPB) group |
| FICB | Active comparator | Patients was placed insupine position . the block performed using a mixture of 15mls bupivcaine 0,5% and 20mls normal saline. Receives: Procedure: Fascia iliaca compartment block (FICB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of the block
time starting immediatelyafter giving the block till the first postoperative analgesic rescue which will be used if the pain score exceeds 4/10
Measured: 15 minutes after extubation till 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start5 Mar 2025
- Primary completion10 Jul 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia After Fracture Femur SurgeriesStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wissam Ahmed Mohamed El Damacey, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990958
- Sponsor's protocol ID
- MS-212-2023
- Status last verified
- Nov 2025
- First submitted
- 18 May 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Fascia Iliaca Compartment Block for Analgesia in Proximal and Midshaft Femur Surgeries in Adult Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06990958
- Acronym / sponsor ID
- MS-212-2023
- Conditions
- Analgesia After Fracture Femur Surgeries
- Keywords
- Fascia iliac block, erector spinae block, femur fracture, adult analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 25 May 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.
This clinical study compares two types of nerve blocks used to control pain in adult patients undergoing surgery on the upper (proximal) or middle (midshaft) part of the femur (thigh bone). The two blocks being studied are the Erector Spinae Plane (ESP) block and the Fascia Iliaca Compartment (FIC) block. Both techniques are commonly used in hospitals to reduce postoperative pain.
The goal is to determine which nerve block provides more effective pain relief, reduces the need for opioid medications, and supports faster recovery in patients following femur surgery. Results from this study may improve pain management strategies for similar procedures in the future.
Adults scheduled for proximal or midshaft femur surgery may be eligible to participate. Eligibility is determined based on clinical criteria reviewed by the study team.Administration of one of the two nerve blocks before surgery.Standard surgical and postoperative care.
Monitoring of pain levels at specific time points after surgery
Recording of opioid medication usage
Evaluation of patient satisfaction and any side effects related to the nerve block
Duration:
The intervention (nerve block) is administered once before surgery. Data collection continues during the immediate postoperative period and for a short time following surgery to assess outcomes.
Both nerve blocks are considered safe and are regularly used in clinical practice.
All procedures are performed by qualified clinicians, and safety monitoring is conducted throughout the study.
Participants may experience improved pain relief and reduced need for opioid medications. While direct benefit cannot be guaranteed, information gained from the study may help improve pain management for future patients undergoing similar surgeries.
Participation in the study is completely voluntary. Patients may choose not to participate or may withdraw from the study at any time without affecting the quality of their medical care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB Group | Active comparator | Procedure: Erector Spinae Plane Block (ESPB) grouppatients was placed in the lateral position . the block was performed bz ipsilateral injection of a mixture containing 15mls bupivcaine 0,5% and 20mls normal saline. |
| FICB | Active comparator | Procedure: Fascia iliaca compartment block (FICB)Patients was placed insupine position . the block performed using a mixture of 15mls bupivcaine 0,5% and 20mls normal saline. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18-80
- American society of Anathesiologist physical status ASA Ior II
- Patients undergoing Fixation of femur fractures
Key exclusion criteria (4 listed)
- Refusal of participation in study.
- Bleeding disorders (platelets count \< 80,000, INR \>1.5, Prothrombin concentration \< 60%).
- Skin lesion, wounds or infection at the puncture site. Known allergy to local anesthetic drugs.
- Known local anesthetic (LA) drug sensitivity. -
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 |
|---|---|---|
| Erector Spinae Plane Block (ESPB) groupultrasound guided erector spinae plane block (at lumbar level) in lateral position . | Procedure or surgery | ESPB Group |
| Fascia iliaca compartment block (FICB)ultrasound guided suprainguinal approach in supine position | Procedure or surgery | FICB |
Primary outcome
duration of the block
Time frame: 15 minutes after extubation till 24 hours postoperative
time starting immediatelyafter giving the block till the first postoperative analgesic rescue which will be used if the pain score exceeds 4/10
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 2 Dec 2025.
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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 study testing Erector Spinae Plane Block (ESPB) group and Fascia iliaca compartment block (FICB) in people with Analgesia After Fracture Femur Surgeries, run by Cairo 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 3 inclusion and 4 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 2 Dec 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 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.
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?
duration of the block (time frame: 15 minutes after extubation till 24 hours 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 2 Dec 2025.