Determination of Utility of Intergluteal Cleft as Landmark for Neuraxial Midline in Obstetrics

NCT05983029 | Recruiting

• 1 other identifier: 291462
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Our aim is to investigate whether a novel landmark, the groove between the buttocks or the intergluteal cleft, can facilitate the identification of the neuraxial midline in obstetric patients when compared to ultrasound as the reference standard for the determination of this midline

Conditions

Obstetric Anesthesia Problems

Outcome Measures

Primary Outcomes (1)

• Horizontal distance between intergluteal cleft and neuraxial midline

  One horizontal distance and hence one primary outcome

  12 months

Secondary Outcomes (3)

• Difference in horizontal distance stratified by body mass index

  12 months

• Difference in horizontal distance stratified by presence of pre-eclampsia

  12 months

• Difference in horizontal distance stratified by presence of pregnancy induced hypertension

  12 months

Study Arms (1)

Study Group

Each patient will be requested to adopt a standardised upright position. First, two of the investigators will use a spirit level ruler and ink pen to agree upon and visibly mark the horizontal intercristal line on the back of the patient. Second, investigator B will leave the room, and investigator A will make a vertical mark with an ultraviolet pen denoting the intersection of the inferior aspect of the intergluteal cleft and the horizontal intercristal line. Third, investigator A will then leave the room, and investigator B will return to the room to make a vertical mark with an ink pen representing the intersection of the neuraxial midline, as established with the transverse spinous process view on ultrasound, and the horizontal intercristal line. After these two vertical marks have been made at the level of the intercristal line, the horizontal distance between them will be measured in mm by these same two investigators

Diagnostic Test: Intergluteal Cleft; Diagnostic Test: Neuraxial Midline; Diagnostic Test: Horizontal Distance between Vertical Markings

Interventions

Intergluteal Cleft DIAGNOSTIC_TEST

Marking of intersection between inferior aspect of the intergluteal cleft and the horizontal intercristal line

Study Group

Neuraxial Midline DIAGNOSTIC_TEST

Marking of intersection between the neuraxial midline, as established with the transverse spinous process view on ultrasound, and the horizontal intercristal line

Study Group

Horizontal Distance between Vertical Markings DIAGNOSTIC_TEST

The horizontal distance between these two vertical marks will be measured at the level of the intercristal line

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients

You may qualify if:

• Female
• years of age or older
• Gestation of 37 weeks or above

You may not qualify if:

• Acute or chronic confusional state
• Allergy to ultrasound gel
• Positive for COVID-19 and/or presence of symptoms consistent with SARS-Cov-2, such as anosmia, cough or fever
• History of previous surgery to the spine
• Scoliosis
• Unable to speak and/or understand English

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's Hospital, Great Maze Pond

London, SE1 9RT, United Kingdom

RECRUITING

Study Officials

• Gill Arbane, BSc

  Guys' & St Thomas' NHS Foundation Trust

  STUDY CHAIR

Central Study Contacts

Neel Desai, FRCA

CONTACT

02071887188; Neel.Desai@gstt.nhs.uk

Marwa Salman, FRCA

CONTACT

02071887188; Marwa.Salman@gstt.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: August 9, 2023
• Study Start: December 7, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)