Effect of Small Versus Large Epidural Needles on Postdural Puncture Headache Study

NCT00370604 | Completed DMC

• 1 other identifier: 1-PAngle
• Study Type: interventional
• Target: 1,081
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to determine the effect of 19g versus =\>18g traditional Tuohy-type epidural needles on the incidence and severity of postdural puncture headache (PDPH).

Conditions

Post-Dural Puncture Headache

Keywords

Parturient; Obstetrics; Pregnancy; Labour; Labor; Headache; Epidural; Analgesia; Anesthesia; Anaesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of postdural puncture headache

  within the first 14 days of epidural placement

Secondary Outcomes (12)

• PDPH characteristics (quality, distribution, postural versus non-postural nature, associated symptoms)

  within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement

• Severity of pain related to PDPH

  within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement

• Degree of dysfunction and disability related to PDPH symptoms

  within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement

• Duration of PDPH-related symptoms

  within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement

• Pain and pain relief (first and second stage labor analgesia following epidural placement and overall pain relief) as rated by the patient, compared between groups

  within 24 hours of epidural placement

Study Arms (2)

1

EXPERIMENTAL

19g needle, 23g catheter

Device: 19g Tuohy-type epidural needle, 23g catheter

2

ACTIVE COMPARATOR

traditional =\>18g needle

Device: => 18g Tuohy-type needle

Interventions

19g Tuohy-type epidural needle, 23g catheter DEVICE

Patients in the experimental group will receive a 23g 90cm adult length epidural catheter placed via a 19g Tuohy epidural needle (SIMS Portex, Hythe, UK). The 19g Tuohy needle is a standard 3½ inch length.

Also known as: Health Canada Health Protection Branch (HPB) Licence # 6832, Smith's Medical epidural mini-kits 100/391/190

1

=> 18g Tuohy-type needle DEVICE

Patients in the control arm will receive a traditional large gauge (16g, 17g or 18g Tuohy or Hustead) epidural needle and a traditional epidural catheter. Two control needles and two control catheters will be designated apriori by each institution for use in the study.

Also known as: Hustead, Tuohy

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists status 1 to 2
• Must have provided written informed consent = or \< 6cm cervical dilation
• Fetus 37 to 42 weeks gestation
• Must be able to read and write English well enough to provide written informed consent

You may not qualify if:

• BMI = or \> 40
• Multiple gestation pregnancy
• Known contraindications to use of epidural analgesia
• Pregnancy-induced hypertension
• Investigator concern for maternal or neonatal welfare
• Receipt of spinal or epidural anesthesia within 14 days of labour epidural request
• Women with chronic headaches (defined as headaches that occur 15 or more days per month for more than 3 months)
• Already participated in study
• History of narcotic abuse

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• The Physicians' Services Incorporated Foundation: collaborator
• Canadian Anesthesiologists' Society: collaborator

Study Sites (4)

British Columbia Women's Hospital and Health Centre

Vancouver, British Columbia, V6H 3N1, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3J 3G9, Canada

Location

St. Joseph's Hospital

London, Ontario, N6A 4V2, Canada

Location

Sunnybrook Health Sciences Centre at Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Related Publications (1)

• Angle PJ, Hussain K, Morgan A, Halpern SH, Van der Vyver M, Yee J, Kiss A. High quality labour analgesia using small gauge epidural needles and catheters. Can J Anaesth. 2006 Mar;53(3):263-7. doi: 10.1007/BF03022213.

  PMID: 16527791 RESULT

MeSH Terms

Conditions

Post-Dural Puncture Headache; Headache; Agnosia

Interventions

Catheters

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Pamela J Angle, MD, MSc

  Women's College Hospital at Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Director, Associate Scientist, Anesthesiologist

Study Record Dates

• First Submitted: August 29, 2006
• First Posted: August 31, 2006
• Study Start: June 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 9, 2022

Record last verified: 2022-06

Locations

CA (4)