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Comparison of Ultrasound-Guided Fascia Iliaca Compartment Block Versus Intravenous Tramadol for Positioning of Femur Fracture Patients Before Spinal Anaesthesia

Comparison of Ultrasound-Guided Fascia Iliaca Compartment Block Versus Intravenous Tramadol for Positioning of Femur Fracture Patients Before Spinal Anaesthesia

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07735884
Enrollment
64
Registered
2026-07-30
Start date
2024-08-10
Completion date
2025-02-10
Last updated
2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain, Femoral Fractures

Keywords

Ultrasound-Guided Fascia Iliaca Compartment Block, Intravenous Tramadol, Femoral Fracture, Spinal Anaesthesia, Lateral Decubitus Position

Brief 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 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.

Interventions

An ultrasound-guided infrainguinal fascia iliaca compartment block was administered with 30 mL of 1% lidocaine containing adrenaline.

DRUGTramadol

Tramadol was administered intravenously at a dose of 1 mg/kg before positioning for spinal anaesthesia.

Sponsors

Mayo Hospital Lahore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Pain Intensity During Positioning for Spinal Anaesthesia10 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.

Secondary

MeasureTime frameDescription
Change in Visual Analogue Scale Pain Score From Baseline to Positioning10 minutes after intravenous tramadol or 15 minutes after fascia iliaca compartment block.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.

Countries

Pakistan

Contacts

PRINCIPAL_INVESTIGATORAdeel Ahmed

Mayo Hospital Lahore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026