A Trial of the Use of Ultrasound to Aid the Insertion of Combined Spinal Epidural Anaesthesia

NCT00166699 | Completed Phase 3

• 2 other identifiers: 04AN003(1)rec reference number04AN003(1)
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 5

Brief Summary

The study will establish whether the use of ultrasound scanning with a purpose built probe will aid the insertion of the needles for epidural and spinal anaesthesia for obese women undergoing elective caesarean section The study group will be 46 obese women (defined by the ratio of height to weight) at time of initial booking ultrasound scan, undergoing routine caesarean section with no serious illnesses that are both willing and able to provide informed consent prior to spinal epidural anaesthesia. Patients will be excluded if they have signs or symptoms of systemic or local infection, if they have a history of previous spinal surgery, a blood clotting abnormities. In order to evaluate the clinical usefulness of the ultrasound probe a randomised comparison of the traditional clinical methods of feeling the bones of the spine and ultrasound guided insertion of a combined spinal epidural anaesthetic will be undertaken. The rodiera tiped 17/18G 90mm tuohy needle and 123mm 27G spinal needle manufactured by Sarstedt will be the regional needles used for the combined spinal epidural anaesthetic. Randomisation into two groups (ultrasound guided needle insertion and feeling the bones) will be by computer generated random sequence. This information will be recorded in sealed envelopes and placed in the ward. Patients who meet the inclusion criteria and who consent immediately prior to caesarean section will be sequentially assigned a number that will correspond to a sealed envelope. The main aim of the study will be to detect any difference in time taken to insert epidural catheter via the needle in the patients back. The other factors measured will be the number of times the skin is punctured and bone touched by the needle, number of conversions from regional (spinal epidural) to general anaesthesia, patient satisfaction scores, requirement for extra local anaesthetic following initial blockade during Caesarean section. The factors will be compared by student t-test using Statistica6 (StatSoft,Inc.(2001). STATISTICA (data analysis software system), version 6. www.statsoft.com). A population of 46 patients will be required assuming a mean time for inserting a combined spinal epidural without

Conditions

Obesity; Pregnancy

Keywords

ultrasonography; obesity; Cesarean Section; Anesthesia; Epidural

Outcome Measures

Primary Outcomes (1)

• The primary end point will be time taken to insert an epidural catheter.

  During the c-section

Secondary Outcomes (8)

• The number of times the skin is punctured

  anaesthesia induction

• The number of times the cortex of bone touched by the epidural needle

  anaesthesia induction

• The number of conversions from regional (central-neuraxial) to general anaesthesia

  anaesthesia induction

• Patient satisfaction scores immediately post op and at 30 minutes post op

  30mins post operatively

• The volume and concentration of supplementary local anaesthetic administration following primary spinal blockade during caesarean section

  intraoperatively

Study Arms (2)

Palpation

NO INTERVENTION

Use of palpation to guide the the insertion site of combined spinal epidural needle in obese parturients

ultrasound

EXPERIMENTAL

The use of ultrasound to guide the insertion of a combined spinal epidural needle

Procedure: ultrasound

Interventions

ultrasound PROCEDURE

The use of ultrasound to guide the insertion of combined spinal epidural needle

Also known as: Split array transducer

ultrasound

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective Caesarean section \> 38/52 gestation
• BMI at booking scan (circia 13/52 gestation)\>=35
• ASA = 1,2 or 3 patients only

You may not qualify if:

• Abnormal clotting screen (coagulopathy) or thrombocytopenia ( \< 100,000)
• Unable to give informed consent to combined spinal epidural anaesthesia
• Previous spinal surgery or known spinal pathology
• Signs, symptoms or laboratory evidence of local infection or systemic sepsis

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Study Sites (5)

Princess Royal maternity

Glasgow, Scotland, United Kingdom

Location

Queen mother's maternity

Glasgow, Scotland, United Kingdom

Location

Southern general maternity hospital

Glasgow, Scotland, United Kingdom

Location

Paisley maternity hospital

Paisley, Scotland, United Kingdom

Location

Wishaw Maternity hospital

Wishaw, Scotland, United Kingdom

Location

MeSH Terms

Conditions

Obesity

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• malcolm J watson, MBCHB

  North Glasgow University Hospitals Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: September 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: June 11, 2008

Record last verified: 2008-06

Locations

GB (5)