Can the Femoral Nerve Block be Improved by Ultrasound Guidance?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by NHS Greater Glasgow and Clyde.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Golden Jubilee National Hospital
Information provided by:
NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT00696150
First received: June 9, 2008
Last updated: June 11, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Pain
Procedure: determination of method with highest efficacy (ultrasound or nerve stimulator)
Procedure: nerve stimulator
Procedure: loss of resistance
Phase 4

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

Resource links provided by NLM:


Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • percentage of patients with effective regional analgesia [ Time Frame: Induction of anaesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hospital mortality [ Time Frame: 1months after operation ] [ Designated as safety issue: Yes ]
  • sensory function in lateral cutaneous nerve [ Time Frame: 0mins, 10mins 20mins post insertion of local anaesthetic ] [ Designated as safety issue: No ]
  • sensory function of femoral nerve [ Time Frame: 0mins, 10mins, 20mins after insertion of local anesthetic ] [ Designated as safety issue: No ]
  • sensory function of obturator nerve [ Time Frame: 0mins, 10mins, 20mins after insertion of local anesthetic ] [ Designated as safety issue: No ]
  • motor function of obturator nerve [ Time Frame: 0mins, 10mins and 20minutes after insrtion of local anesthetic ] [ Designated as safety issue: No ]
  • motor function of femoral nerve [ Time Frame: 0mins,10mins and 20mins post insertion of local anesthetic ] [ Designated as safety issue: No ]
  • acute mental test scores [ Time Frame: 6hours and 24 hours post operatively ] [ Designated as safety issue: No ]
  • total morphine dose administered [ Time Frame: 6hours and 24 hours post operstively ] [ Designated as safety issue: No ]
  • day first mobilise post operatively [ Time Frame: post operatively 0-10 days ] [ Designated as safety issue: No ]
  • patient satisfaction scores [ Time Frame: 6 hours and 24hours post operatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 269
Study Start Date: July 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696150

Contacts
Contact: Malcolm Watson, MBChB, MRCP, FRCA 01412116291 mwatson@doctors.org.uk

Locations
United Kingdom
Gartnavel General hospital Not yet recruiting
Glasgow, Lanarkshire, United Kingdom, G12 0YN
Principal Investigator: Graham Hilditch, MB chB, FRCA         
Glasgow Royal Infrimary Not yet recruiting
Glasgow, Lanarkshire, United Kingdom, G4
Principal Investigator: Colin Rae, Mb chB, FRCA         
Golden Jubilee hospital Not yet recruiting
Glasgow, Lanarkshire, United Kingdom
Principal Investigator: Micheal Higgins, MB chB, FRCA         
Royal alexandra hospital Not yet recruiting
Paisley, Renfrewshire, United Kingdom, PA2
Principal Investigator: Paul Allcock, Mb ChB, FRCS         
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Golden Jubilee National Hospital
Investigators
Study Chair: Malcolm watson, MB ChB FRCA NHS Greater Glasgow and Clyde Health Board
  More Information

No publications provided

Responsible Party: Dr Erica Packard, NHS Greater Glasgow and Clyde health board
ClinicalTrials.gov Identifier: NCT00696150     History of Changes
Other Study ID Numbers: ultrasound for hip # study-1, CSO reference CAF/07/05
Study First Received: June 9, 2008
Last Updated: June 11, 2008
Health Authority: United Kingdom: Department of Health

Keywords provided by NHS Greater Glasgow and Clyde:
ultrasound
hip
pain

ClinicalTrials.gov processed this record on October 21, 2014