Can the Femoral Nerve Block be Improved by Ultrasound Guidance?

NHS Trust

Status and phase: Unknown; Phase 4

Conditions: Pain

Treatments: Procedure: loss of resistance; Procedure: determination of method with highest efficacy (ultrasound or nerve stimulator); Procedure: nerve stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT00696150

CSO reference CAF/07/05

ultrasound for hip # study-1

Details and patient eligibility

About

Studies have suggested a link with effective pain relief and reduced illness and death in very unwell patients. This study will determine the most effective method of injecting local anaesthetic around the nerves which supply the hip joint. Local anaesthetic will be injected around the hips nerve supply using either ultrasound, loss of resistance or electrical nerve stimulator to guide the positioning of the needle on patients due for elective total hip replacement. The patient will then be observed for 30 minutes and the patient ability to move or feel the upper leg will recorded. A standard anaesthetic and a hip replacement operation will then be performed. Standard pain relief protocols will be used the operation and after the operation. After the operation we will record the amount of morphine used and how happy the patients have been with their treatment at 6 hours after the operation and at 24 hours after the operation. The first day the patient is able to walk on their new hip replacement will also be recorded.

Enrollment: 269 estimated patients

Sex: All

Ages: 35 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective primary total hip arthroplasty under general anaesthesia
• ASA<=4
• Able to give informed consent
• Able to cooperate with sensory and motor testing of lower limb function

Exclusion criteria

• Abnormal clotting screen (coagulopathy) or thrombocytopenia (<100,000)
• Acute mental test score of <=7 at any time pre or post operatively
• Allergy to local anaesthetic
• Signs, symptoms or laboratory evidence of local infection or systemic sepsis
• No pre-existing neurological deficit (sensory or motor) affecting lower limb
• Patients with lower limb amputations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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269 participants in 3 patient groups, including a placebo group

loss of resistance

Placebo Comparator group

Description:

Anterior psoas compartment nerve block inserted using loss of resistance

Treatment:

Procedure: loss of resistance

nerve stimulator

Active Comparator group

Description:

Anterior psoas compartment nerve block inserted using nerve stimulator

Treatment:

Procedure: nerve stimulator

Procedure: determination of method with highest efficacy (ultrasound or nerve stimulator)

ultrasound

Active Comparator group

Description:

Anterior psoas compartment nerve block inserted using ultrasound

Treatment:

Procedure: determination of method with highest efficacy (ultrasound or nerve stimulator)