Can the Femoral Nerve Block be Improved by Ultrasound Guidance?

Can the Use of Ultrasound to Guide the Insertion of a Needle for an Anterior Psoas Compartment Nerve Block Increase Its Efficacy in Comparison to Traditional Techniques Utilising Loss of Resistance and Nerve Stimulation?

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.

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Procedure: loss of resistance; Procedure: determination of method with highest efficacy (ultrasound or nerve stimulator); Procedure: nerve stimulator

• Study Type: Interventional
• Enrollment (Anticipated): 269
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Lanarkshire
    • Glasgow, Lanarkshire, United Kingdom, G12 0YN
      • Gartnavel General Hospital
    • Glasgow, Lanarkshire, United Kingdom, G4
      • Glasgow Royal Infrimary
    • Glasgow, Lanarkshire, United Kingdom
      • Golden Jubilee Hospital
  • Renfrewshire
    • Paisley, Renfrewshire, United Kingdom, PA2
      • Royal Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: loss of resistance; Anterior psoas compartment nerve block inserted using loss of resistance	Procedure: loss of resistance; Use of ultrasound to guide the insertion of anterior psoas compartment block
Active Comparator: nerve stimulator; Anterior psoas compartment nerve block inserted using nerve stimulator	Procedure: determination of method with highest efficacy (ultrasound or nerve stimulator); Use of ultrasound to guide the insertion of anterior psoas compartment block; Procedure: nerve stimulator; The use of the nerve stimulator to guide insertion of the anterior psoas compartment block
Active Comparator: ultrasound; Anterior psoas compartment nerve block inserted using ultrasound	Procedure: determination of method with highest efficacy (ultrasound or nerve stimulator); Use of ultrasound to guide the insertion of anterior psoas compartment block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
percentage of patients with effective regional analgesia	Induction of anaesthesia

Secondary Outcome Measures

Outcome Measure	Time Frame
hospital mortality	1months after operation
sensory function in lateral cutaneous nerve	0mins, 10mins 20mins post insertion of local anaesthetic
sensory function of femoral nerve	0mins, 10mins, 20mins after insertion of local anesthetic
sensory function of obturator nerve	0mins, 10mins, 20mins after insertion of local anesthetic
motor function of obturator nerve	0mins, 10mins and 20minutes after insrtion of local anesthetic
motor function of femoral nerve	0mins,10mins and 20mins post insertion of local anesthetic
acute mental test scores	6hours and 24 hours post operatively
total morphine dose administered	6hours and 24 hours post operstively
day first mobilise post operatively	post operatively 0-10 days
patient satisfaction scores	6 hours and 24hours post operatively

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: Golden Jubilee National Hospital
• Investigators: Study Chair: Malcolm watson, MB ChB FRCA, NHS Greater Glasgow and Clyde

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Anticipated): July 1, 2010
• Study Completion (Anticipated): August 1, 2010

Study Registration Dates

• First Submitted: June 9, 2008
• First Submitted That Met QC Criteria: June 11, 2008
• First Posted (Estimate): June 12, 2008

Study Record Updates

• Last Update Posted (Estimate): June 12, 2008
• Last Update Submitted That Met QC Criteria: June 11, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: pain; ultrasound; hip
• Other Study ID Numbers: ultrasound for hip # study-1; CSO reference CAF/07/05