Femoral FracturesNCT07735884
Comparison of Ultrasound-Guided Fascia Iliaca Compartment Block Versus Intravenous Tramadol for Positioning of Femur Fracture Patients Before Spinal Anaesthesia
A study testing Ultrasound-Guided Fascia Iliaca Compartment Block and Tramadol in people with Femoral Fractures and Acute Pain, run by Mayo Hospital Lahore at 1 site in Pakistan.
Trial summary
This randomized clinical study compared two methods of pain relief used before spinal anaesthesia in patients undergoing surgery for a femur fracture. Positioning a patient with a fractured femur into the side-lying position required for spinal anaesthesia can cause severe pain because movement may disturb the… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Femoral Fractures, Acute Pain
- What is being tested?
- Ultrasound-Guided Fascia Iliaca Compartment Block and Tramadol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Aug 2024to 10 Feb 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years
- Male or female patients
- American Society of Anesthesiologists physical status I or II
- Patients scheduled for femur fracture surgery under spinal anaesthesia
Who cannot join
- Multiple fractures
- Peripheral neuropathy
- Inability to communicate or provide reliable pain assessment
- History of allergy to local anaesthetic agents
- Contraindication to spinal anaesthesia, including:
- Patient refusal
- Local infection at the injection site
- Coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
This randomized clinical study compared two methods of pain relief used before spinal anaesthesia in patients undergoing surgery for a femur fracture. Positioning a patient with a fractured femur into the side-lying position required for spinal anaesthesia can cause severe pain because movement may disturb the fractured bone.
A total of 64 patients aged 18 to 60 years were included and were assigned to one of two treatment groups. One group received intravenous tramadol, while the other group received an ultrasound-guided fascia iliaca compartment block, in which local anaesthetic was injected near the nerves supplying the hip and upper thigh. Pain was measured using a visual analogue scale when the patient arrived on the operating table and again during positioning in the lateral decubitus position before spinal anaesthesia.
The study was conducted to determine which treatment provided better pain relief and made positioning for spinal anaesthesia more comfortable. It was hypothesized that the ultrasound-guided fascia iliaca compartment block would reduce pain during positioning more effectively than intravenous tramadol.
- Conditions
- Femoral Fractures, Acute Pain
- Being tested
- Ultrasound-Guided Fascia Iliaca Compartment Block, Tramadol
- Keywords
- Ultrasound-Guided Fascia Iliaca Compartment Block, Intravenous Tramadol, Femoral Fracture, Spinal Anaesthesia, Lateral Decubitus Position
- Medical subject headings
- Femoral Fractures, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Fascia Iliaca Compartment BlockProcedure or surgery
An ultrasound-guided infrainguinal fascia iliaca compartment block was administered with 30 mL of 1% lidocaine containing adrenaline.
TramadolDrug
Tramadol was administered intravenously at a dose of 1 mg/kg before positioning for spinal anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Fascia Iliaca Compartment Block Group | Experimental | Participants received an ultrasound-guided fascia iliaca compartment block through the infrainguinal approach using 30 mL of 1% lidocaine with adrenaline. After 15 minutes, participants were positioned in the lateral decubitus position for spinal anaesthesia, and pain intensity was assessed using the visual analogue scale. Receives: Procedure: Ultrasound-Guided Fascia Iliaca Compartment Block |
| Intravenous Tramadol Group | Active comparator | Participants received intravenous tramadol at a dose of 1 mg/kg. After 10 minutes, participants were positioned in the lateral decubitus position for spinal anaesthesia, and pain intensity was assessed using the visual analogue scale. Receives: Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity During Positioning for Spinal Anaesthesia
Pain intensity was assessed using a 0-10 visual analogue scale during placement of the participant in the lateral decubitus position before spinal anaesthesia. A score of 0 represented no pain, while a score of 10 represented the worst possible pain. Lower scores indicated better analgesic efficacy.
Measured: 10 minutes after intravenous tramadol or 15 minutes after ultrasound-guided fascia iliaca compartment block, immediately before spinal anaesthesia.
Secondary outcomes (1)
Change in Visual Analogue Scale Pain Score From Baseline to Positioning
The change in pain intensity was determined by comparing the visual analogue scale score recorded while the participant was lying on the operating table before the assigned intervention with the score recorded during lateral decubitus positioning. A greater reduction in score indicated greater analgesic effectiveness.
Measured: 10 minutes after intravenous tramadol or 15 minutes after fascia iliaca compartment block.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start10 Aug 2024
- Primary completion10 Feb 2025
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral FracturesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Hospital Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adeel Ahmed, Mayo Hospital Lahore
- Investigators
- Adeel Ahmed, Principal investigator, Mayo Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735884
- Sponsor's protocol ID
- Mayo8
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2026
- Last updated
- 30 Jul 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-Guided Fascia Iliaca Compartment Block Versus Intravenous Tramadol for Positioning of Femur Fracture Patients Before Spinal Anaesthesia
- ClinicalTrials.gov ID
- NCT07735884
- Acronym / sponsor ID
- Mayo8
- Conditions
- Femoral Fractures, Acute Pain
- Keywords
- Ultrasound-Guided Fascia Iliaca Compartment Block, Intravenous Tramadol, Femoral Fracture, Spinal Anaesthesia, Lateral Decubitus Position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mayo Hospital LahoreUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 30 Jul 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 randomized clinical study compared two methods of pain relief used before spinal anaesthesia in patients undergoing surgery for a femur fracture. Positioning a patient with a fractured femur into the side-lying position required for spinal anaesthesia can cause severe pain because movement may disturb the fractured bone.
A total of 64 patients aged 18 to 60 years were included and were assigned to one of two treatment groups. One group received intravenous tramadol, while the other group received an ultrasound-guided fascia iliaca compartment block, in which local anaesthetic was injected near the nerves supplying the hip and upper thigh. Pain was measured using a visual analogue scale when the patient arrived on the operating table and again during positioning in the lateral decubitus position before spinal anaesthesia.
The study was conducted to determine which treatment provided better pain relief and made positioning for spinal anaesthesia more comfortable. It was hypothesized that the ultrasound-guided fascia iliaca compartment block would reduce pain during positioning more effectively than intravenous tramadol.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Fascia Iliaca Compartment Block Group | Experimental | Procedure: Ultrasound-Guided Fascia Iliaca Compartment BlockParticipants received an ultrasound-guided fascia iliaca compartment block through the infrainguinal approach using 30 mL of 1% lidocaine with adrenaline. After 15 minutes, participants were positioned in the lateral decubitus position for spinal anaesthesia, and pain intensity was assessed using the visual analogue scale. |
| Intravenous Tramadol Group | Active comparator | Drug: TramadolParticipants received intravenous tramadol at a dose of 1 mg/kg. After 10 minutes, participants were positioned in the lateral decubitus position for spinal anaesthesia, and pain intensity was assessed using the visual analogue scale. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60 years
- Male or female patients
- American Society of Anesthesiologists physical status I or II
- Patients scheduled for femur fracture surgery under spinal anaesthesia
Key exclusion criteria (8 listed)
- Multiple fractures
- Peripheral neuropathy
- Inability to communicate or provide reliable pain assessment
- History of allergy to local anaesthetic agents
- Contraindication to spinal anaesthesia, including:
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 |
|---|---|---|
| Ultrasound-Guided Fascia Iliaca Compartment BlockAn ultrasound-guided infrainguinal fascia iliaca compartment block was administered with 30 mL of 1% lidocaine containing adrenaline. | Procedure or surgery | Ultrasound-Guided Fascia Iliaca Compartment Block Group |
| TramadolTramadol was administered intravenously at a dose of 1 mg/kg before positioning for spinal anaesthesia. | Drug | Intravenous Tramadol Group |
Primary outcome
Pain Intensity During Positioning for Spinal Anaesthesia
Time frame: 10 minutes after intravenous tramadol or 15 minutes after ultrasound-guided fascia iliaca compartment block, immediately before spinal anaesthesia.
Pain intensity was assessed using a 0-10 visual analogue scale during placement of the participant in the lateral decubitus position before spinal anaesthesia. A score of 0 represented no pain, while a score of 10 represented the worst possible pain. Lower scores indicated better analgesic efficacy.
1 secondary outcome
Change in Visual Analogue Scale Pain Score From Baseline to Positioning
Time frame: 10 minutes after intravenous tramadol or 15 minutes after fascia iliaca compartment block.
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 30 Jul 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.
Adeel Ahmed principal investigator
Mayo Hospital Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Fascia Iliaca Compartment Block and Tramadol in people with Femoral Fractures and Acute Pain, run by Mayo Hospital Lahore at 1 site in Pakistan.
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 30 Jul 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 Pakistan. 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?
Pain Intensity During Positioning for Spinal Anaesthesia (time frame: 10 minutes after intravenous tramadol or 15 minutes after ultrasound-guided fascia iliaca compartment block, immediately before spinal anaesthesia.). 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 Jul 2026.