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

Recruiting

• Conditions: Obstetric Anesthesia Problems
• Interventions: Diagnostic Test: Intergluteal Cleft; Diagnostic Test: Neuraxial Midline; Diagnostic Test: Horizontal Distance between Vertical Markings

• Registration Number: NCT05983029
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2023-08-08
• Study First Posted: 2023-08-09
• Study Start: 2023-12-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 99

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Intergluteal Cleft	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
Study Group	Neuraxial Midline	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
Study Group	Horizontal Distance between Vertical Markings	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

Primary Outcome Measures

Name	Time	Method
Horizontal distance between intergluteal cleft and neuraxial midline	12 months	One horizontal distance and hence one primary outcome

Secondary Outcome Measures

Name	Time	Method
Difference in horizontal distance stratified by presence of pregnancy induced hypertension	12 months	Variation for pregnancy induced hypertension a and recorded data
Difference in horizontal distance stratified by presence of pre-eclampsia	12 months	Variation for pre-ecalmpsia and recorded data
Difference in horizontal distance stratified by body mass index	12 months	Variation for BMI and recorded data

Trial Locations

Locations (1)

Guy's Hospital, Great Maze Pond; 🇬🇧 London, United Kingdom