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

NCT ID: NCT05983029

Last Updated: 2024-02-28

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

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Recruitment Status

RECRUITING

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-07

Study Completion Date

2024-09-01

Brief Summary

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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

Detailed Description

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Determine if the intergluteal cleft, when compared to ultrasound as the reference standard, can be used to identify the neuraxial midline in obstetric patients

Difference in horizontal distance between the vertical lines of the intergluteal cleft and the neuraxial midline, the latter measured with ultrasound

Conditions

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Obstetric Anesthesia Problems

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Intergluteal Cleft

Intervention Type DIAGNOSTIC_TEST

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

Neuraxial Midline

Intervention Type DIAGNOSTIC_TEST

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

Horizontal Distance between Vertical Markings

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Intergluteal Cleft

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

Intervention Type DIAGNOSTIC_TEST

Neuraxial Midline

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

Intervention Type DIAGNOSTIC_TEST

Horizontal Distance between Vertical Markings

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Female
* 18 years of age or older
* Gestation of 37 weeks or above

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gill Arbane, BSc

Role: STUDY_CHAIR

Guys' & St Thomas' NHS Foundation Trust

Locations

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Guy's Hospital, Great Maze Pond

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Neel Desai, FRCA

Role: CONTACT

02071887188

Marwa Salman, FRCA

Role: CONTACT

02071887188

Facility Contacts

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Gill Arbane

Role: primary

0207 188 8070

Other Identifiers

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291462

Identifier Type: -

Identifier Source: org_study_id

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