Can the Femoral Nerve Block be Improved by Ultrasound Guidance?

Pain Clinical Trial

Official title:

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?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00696150
• Other study ID #: ultrasound for hip # study-1
• Secondary ID: CSO reference CA
• Status: Not yet recruiting
• Phase: Phase 4
• First received: June 9, 2008
• Last updated: June 11, 2008
• Start date: July 2008
• Est. completion date: August 2010

Study information

• Verified date: June 2008
• Source: NHS Greater Glasgow and Clyde
• Contact: Malcolm Watson, MBChB, MRCP, FRCA
• Phone: 01412116291
• Email: mwatson[@]doctors.org.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 269
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Procedure:
• determination of method with highest efficacy (ultrasound or nerve stimulator)
Use of ultrasound to guide the insertion of anterior psoas compartment block
• nerve stimulator
The use of the nerve stimulator to guide insertion of the anterior psoas compartment block
• loss of resistance
Use of ultrasound to guide the insertion of anterior psoas compartment block

Locations

Country	Name	City	State
United Kingdom	Gartnavel General hospital	Glasgow	Lanarkshire
United Kingdom	Glasgow Royal Infrimary	Glasgow	Lanarkshire
United Kingdom	Golden Jubilee hospital	Glasgow	Lanarkshire
United Kingdom	Royal alexandra hospital	Paisley	Renfrewshire

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	Golden Jubilee National Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients with effective regional analgesia		Induction of anaesthesia	No
Secondary	hospital mortality		1months after operation	Yes
Secondary	sensory function in lateral cutaneous nerve		0mins, 10mins 20mins post insertion of local anaesthetic	No
Secondary	sensory function of femoral nerve		0mins, 10mins, 20mins after insertion of local anesthetic	No
Secondary	sensory function of obturator nerve		0mins, 10mins, 20mins after insertion of local anesthetic	No
Secondary	motor function of obturator nerve		0mins, 10mins and 20minutes after insrtion of local anesthetic	No
Secondary	motor function of femoral nerve		0mins,10mins and 20mins post insertion of local anesthetic	No
Secondary	acute mental test scores		6hours and 24 hours post operatively	No
Secondary	total morphine dose administered		6hours and 24 hours post operstively	No
Secondary	day first mobilise post operatively		post operatively 0-10 days	No
Secondary	patient satisfaction scores		6 hours and 24hours post operatively	No