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Completed

NCT Number: NCT07735884

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

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.

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Key information

Conditions

Femoral Fractures Acute Pain Fractures, Bone Leg Injuries Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound-Guided Fascia Iliaca Compartment Block

Procedure

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

Tramadol

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

Sponsors and collaborators

Lead sponsor

Mayo Hospital Lahore

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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