Influence of Body Positioning on the Identification of Tuffier's Line Using the Palpation Method: An Ultrasound Study

Influence of Body Positioning on the Identification of Tuffier's Line Using the Traditional Palpation Method: An Ultrasound Study.

The study aims to ascertain whether being placed in a sitting or lateral decubitus position, influences identification of the midpoint of the L4/L5 intervertebral space, using manual demarcation of Tuffier's line. Participants will be randomly assigned to a sitting or lateral decubitus position. The mid-point of the L4/L5 intervertebral space will be identified using anatomical palpation and compared to the "true" mid-point measured by ultrasound. The procedure will be repeated in both positions on the same participant.The study will be a prospective, randomized, double blinded, crossover trial

Study Overview

• Status: Unknown
• Conditions: Pregnant Women
• Intervention / Treatment: Diagnostic test: Ultrasound spine

Detailed Description

Anaesthetists insert epidurals or spinal anaesthetics (collectively called central neuraxial blocks) to patients during childbirth to provide pain relief and anaesthesia. A spinal anaesthetic involves the injection of pain relieving medicines directly into the sac of fluid that surrounds the spinal cord. An epidural uses a different technique to place a thin plastic tube into the fatty tissues that surround this sac. Spinal anaesthesia must be placed below where the spinal cord ends to avoid nerve trauma. Doctors have traditionally been taught to identify a safe level, by feeling the top of a patients hips and drawing an imaginary line between these two points across the patients back known as Tuffier's line. This identifies L4/5 interspace, below which anaesthetists avoids the termination of the spinal cord. The same blind "anatomical rule" is used throughout anaesthetics, whether the patient is male or female, young or old, pregnant or non-pregnant, supine or lateral, an approach that is clearly far from robust. The physiological changes of pregnancy such as fluid retention and weight gain can further make identification of the standard landmarks challenging. Advances in ultrasound technology have allowed direct visualisation of the bones in the back. Studies have shown that the conventional anatomical based method for locating the point of needle insertion is unreliable even amongst experienced anaesthetists.

Spinal or epidural anaesthesia can be performed with the patient either sitting or lying on their side. The investigators aim to determine whether a difference exists between the perceived mid-point of the L4/L5 intervertebral space, identified using manual demarcation of Tuffier's line, in these two positions. Ultrasound will then be used to ascertain the distance from the "true" midpoint.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Recruiting
    • St Thomas' Hospital
    • Contact: Nhathien Nguyen-Lu, BMedSci(Hons) BMBS FRCA; Phone Number: 80652 0207 188 7188; Email: nat.nguyen-lu@gstt.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant parturients in the third trimester.

Description

Inclusion Criteria:

• >37 weeks gestation
• BMI<40
• Singleton pregnancy
• Aged 16 to 65 years old.
• Latent phase of labour (<4cm cervix dilatation).

Exclusion Criteria:

• Previous spinal surgery
• Scoliosis
• Age<16
• Patient unable to tolerate positions
• Degenerative disease of the spine
• Patient refusal or inability to provide informed consent
• Patient in established labour (i.e. >4cm cervical dilatation)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ultrasound Spine in sitting position; Participants will be assigned to a sitting decubitus position to identify the Tuffier's Line	Diagnostic test: Ultrasound spine; A ultrasound of the lumbar spine of each patient will be performed in both positions to identify vertebral levels
Ultrasound Spine in lateral position; Participants will be assigned to a lateral decubitus position to identify the Tuffier's Line	Diagnostic test: Ultrasound spine; A ultrasound of the lumbar spine of each patient will be performed in both positions to identify vertebral levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discrepancy in distance between palpation vs. ultrasound midpoint of L4/5. interspace.	Distance (mm) between the mid-point of the L4/L5 intervertebral space in sitting and lateral decubitus positions, identified through manual palpation compared to the "true" mid-point measured by ultrasound.	15-30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discrepancy in distance between ultrasound midpoint of L4/5 in sitting vs. lateral position	Distance (mm) between the mid-point of the L4/L5 intervertebral space identified by ultrasound in sitting versus lateral decubitus positions.	15-30 minutes

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: Nhathien Nguyen-Lu, FRCA, Guy's and St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 31, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 218764

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No