NCT04779580

Brief Summary

Hip Surgery is a very common form of surgery carried out across many hospitals within the UK in emergency and elective form. There is a variation between amongst surgeons with regard to the initial surgical incision required for the operation. It is fairly common practice to anaesthetise the Lateral Cutaneous Nerve of the thigh for analgesic reasons prior to the start of surgery, however due to the variation in surgical practice (and evolving surgical practices) this may not cover the entire surgical incision site. Another group of nerves termed the subcostal nerves has been described in the texts to perhaps cover the area of surgical incision along with blockade of the lateral cutaneous nerve of the thigh. On healthy volunteers the investigators plan to anaesthetise the lateral cutaneous nerve of the thigh, and the subcostal nerve on healthy participants to ascertain and map out the area of anaesthesia to see whether this could be a viable technique for analgesia for hip surgery in the future.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

February 21, 2021

Last Update Submit

March 2, 2021

Conditions

Keywords

Regional AnaesthesiaHip SurgeryLateral Femoral Cutaneous NerveSubcostal NerveAnalgesiaHip Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Cutaneous area anaesthetised by lateral cutaneous nerve of thigh and subcostal nerve block using local anaesthetic

    Demarcated area of sensory loss after lateral femoral cutaneous nerve block and subcostal nerve block - reported by the participant upon testing the area with cold ice by the investigators. The area will then be assessed by the investigators to assess whether the area of anaesthesia will cover the surgical incision site for hip arthroplasties.

    Duration of Study (approximately 5 months)

Study Arms (1)

Intervention Group (Only Group)

EXPERIMENTAL

Only one group in this study. 10 participants to have intervention. Lateral femoral cutaneous nerve block and evaluation: Routine ECG, pulse oximetry and blood pressure monitoring will be available. Using a sterile technique, the lateral femoral nerve will be approached using an in-plane ultrasound-guided technique, using a Stimuplex Ultra 360 50mm needle (B Braun, UK). Following negative aspiration, a one off STAT injection of 5mls lidocaine 1% will be administered subcutaneously. After 10 minutes, any altered sensation will be assessed using ice to differentiate normal and altered sensation. This area will be marked on the skin using a black marker pen. Photographs will be taken and images of the procedure will be recorded. The above will then be repeated for the subcostal nerve block. The total area of anaesthesia will then be compared to the standard surgical incision for hip surgery to assess whether the subcostal nerve block will offer any further analgesia.

Procedure: Lateral Cutaneous Nerve Of The Thigh Nerve Block Using Local AnaestheticProcedure: Subcostal Nerve Block Using Local Anaesthetic

Interventions

Currently accepted aseptic conditions will be met. The lateral cutaneous nerve of the thigh will be identified on ultrasound (Sonosite X-Porte) and 5mL of 1% lidocaine will be administered around the nerve using a 50mm Stimuplex needle. The area of anaesthesia will be demarcated using ice.

Intervention Group (Only Group)

Currently accepted aseptic conditions will be met. The subcostal nerve will be identified on ultrasound (Sonosite X-Porte) and 5mL of 1% lidocaine will be administered around the nerve using a 50mm Stimuplex needle. The area of anaesthesia will be demarcated using ice.

Intervention Group (Only Group)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.

You may not qualify if:

  • The participant may not enter the study if ANY of the following apply:
  • Peripheral neuropathy of any aetiology
  • Diabetes mellitus
  • Meralgia paraesthetica
  • Previous Total Hip Arthroplasty
  • Sciatica
  • Spinal Stenosis
  • Localised infection of the inguinal or gluteal regions
  • Allergy to local anaesthetic or excipients
  • Inability to identify either the lateral femoral cutaneous nerve or the subcostal nerve using ultrasound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Rudin D, Manestar M, Ullrich O, Erhardt J, Grob K. The Anatomical Course of the Lateral Femoral Cutaneous Nerve with Special Attention to the Anterior Approach to the Hip Joint. J Bone Joint Surg Am. 2016 Apr 6;98(7):561-7. doi: 10.2106/JBJS.15.01022.

    PMID: 27053584BACKGROUND
  • Ray B, D'Souza AS, Kumar B, Marx C, Ghosh B, Gupta NK, Marx A. Variations in the course and microanatomical study of the lateral femoral cutaneous nerve and its clinical importance. Clin Anat. 2010 Nov;23(8):978-84. doi: 10.1002/ca.21043.

    PMID: 20830791BACKGROUND
  • Bodner G, Bernathova M, Galiano K, Putz D, Martinoli C, Felfernig M. Ultrasound of the lateral femoral cutaneous nerve: normal findings in a cadaver and in volunteers. Reg Anesth Pain Med. 2009 May-Jun;34(3):265-8. doi: 10.1097/AAP.0b013e31819a4fc6.

    PMID: 19587628BACKGROUND
  • Anloague PA, Huijbregts P. Anatomical variations of the lumbar plexus: a descriptive anatomy study with proposed clinical implications. J Man Manip Ther. 2009;17(4):e107-14. doi: 10.1179/106698109791352201.

    PMID: 20140146BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • James Stimpson, FRCA

    Queen Elizabeth Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James Stimpson, FRCA

CONTACT

Daniel P White, FRCA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2021

First Posted

March 3, 2021

Study Start

March 1, 2021

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

There is no plan to make IPD available to other researchers