MedDataX Logo

Can the Femoral Nerve Block be Improved by Ultrasound Guidance?

NCT ID: NCT00696150

Last Updated: 2008-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

269 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ultrasound hip pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

loss of resistance

Anterior psoas compartment nerve block inserted using loss of resistance

Group Type PLACEBO_COMPARATOR

loss of resistance

Intervention Type PROCEDURE

Use of ultrasound to guide the insertion of anterior psoas compartment block

nerve stimulator

Anterior psoas compartment nerve block inserted using nerve stimulator

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Use of ultrasound to guide the insertion of anterior psoas compartment block

nerve stimulator

Intervention Type PROCEDURE

The use of the nerve stimulator to guide insertion of the anterior psoas compartment block

ultrasound

Anterior psoas compartment nerve block inserted using ultrasound

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Use of ultrasound to guide the insertion of anterior psoas compartment block

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Use of ultrasound to guide the insertion of anterior psoas compartment block

Intervention Type PROCEDURE

nerve stimulator

The use of the nerve stimulator to guide insertion of the anterior psoas compartment block

Intervention Type PROCEDURE

loss of resistance

Use of ultrasound to guide the insertion of anterior psoas compartment block

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Golden Jubilee National Hospital

OTHER_GOV

Sponsor Role collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

NHS Greater Glasgow and Clyde health board

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Malcolm watson, MB ChB FRCA

Role: STUDY_CHAIR

NHS Greater Glasgow and Clyde

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gartnavel General hospital

Glasgow, Lanarkshire, United Kingdom

Site Status

Glasgow Royal Infrimary

Glasgow, Lanarkshire, United Kingdom

Site Status

Golden Jubilee hospital

Glasgow, Lanarkshire, United Kingdom

Site Status

Royal alexandra hospital

Paisley, Renfrewshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Malcolm Watson, MBChB, MRCP, FRCA

Role: CONTACT

Phone: 01412116291

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CSO reference CAF/07/05

Identifier Type: -

Identifier Source: secondary_id

ultrasound for hip # study-1

Identifier Type: -

Identifier Source: org_study_id