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

This study has been completed.
Sponsor:
Information provided by:
NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT00166699
First received: September 9, 2005
Last updated: June 10, 2008
Last verified: June 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Obesity
Pregnancy
 Procedure: ultrasound
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Clinical Evaluation of a Novel Ultrasound Probe to Guide the Insertion of Central Regional Anaesthesia Using a Regional Anaesthetic Needle Modified to Aid Insertion Under Ultrasound Guidance in Morbidly Obese Women Undergoing Elective Caesarean Section

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • The primary end point will be time taken to insert an epidural catheter. [ Time Frame: During the c-section ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of times the skin is punctured [ Time Frame: anaesthesia induction ] [ Designated as safety issue: No ]
  • The number of times the cortex of bone touched by the epidural needle [ Time Frame: anaesthesia induction ] [ Designated as safety issue: No ]
  • The number of conversions from regional (central-neuraxial) to general anaesthesia [ Time Frame: anaesthesia induction ] [ Designated as safety issue: No ]
  • Patient satisfaction scores immediately post op and at 30 minutes post op [ Time Frame: 30mins post operatively ] [ Designated as safety issue: No ]
  • The volume and concentration of supplementary local anaesthetic administration following primary spinal blockade during caesarean section [ Time Frame: intraoperatively ] [ Designated as safety issue: No ]
  • Number of needle advancements [ Time Frame: Induction of anaesthesia ] [ Designated as safety issue: No ]
  • Number of conversions to general anaesthesia [ Time Frame: induction of anaesthesia ] [ Designated as safety issue: No ]
  • Number of 'dry spinal taps' [ Time Frame: induction of anaesthesia ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: September 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Palpation
Use of palpation to guide the the insertion site of combined spinal epidural needle in obese parturients
Experimental: ultrasound
The use of ultrasound to guide the insertion of a combined spinal epidural needle
 Procedure: ultrasound
The use of ultrasound to guide the insertion of combined spinal epidural needle
Other Name: Split array transducer

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166699

Locations
United Kingdom
Southern general maternity hospital
Glasgow, Scotland, United Kingdom
Princess Royal maternity
Glasgow, Scotland, United Kingdom
Queen mother's maternity
Glasgow, Scotland, United Kingdom
Paisley maternity hospital
Paisley, Scotland, United Kingdom
Wishaw Maternity hospital
Wishaw, Scotland, United Kingdom
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Investigators
Principal Investigator: malcolm J watson, MBCHB North Glasgow University Hospitals Division
  More Information

No publications provided

Responsible Party: erica packard, North Glasgow University NHS Trust
ClinicalTrials.gov Identifier: NCT00166699     History of Changes
Other Study ID Numbers: 04AN003(1), rec reference number04AN003(1)
Study First Received: September 9, 2005
Last Updated: June 10, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by NHS Greater Glasgow and Clyde:
ultrasonography
obesity
Cesarean Section
Anesthesia
Epidural

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013