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

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ClinicalTrials.gov Identifier: NCT00370604
Recruitment Status : Completed
First Posted : August 31, 2006
Last Update Posted : June 23, 2015
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment
Post-Dural Puncture Headache Device: 19g Tuohy-type epidural needle, 23g catheter Device: => 18g Tuohy-type needle

Detailed Description:
A headache is the most significant complication of dural puncture during epidural placement. This complication leads to longer hospital stays and many repeated visits to hospital for management. Women suffering from severe postdural puncture headache (PDPH) are often bedridden and unable to care for themselves or their babies.The efficacy of epidural blood patch as a "gold standard" therapy is over-estimated by the earlier, poor quality studies. The prevalence of dural puncture during epidural anesthesia using current techniques ranges from 0.03 to 6% in the literature. Of these patients, 70 to 80% will suffer from moderate to severe PDPH. Avoidance of dural puncture is always the goal. However, complete avoidance is unlikely using current techniques of needle placement. This study proposes another method of prevention (i.e., reducing the gauge of the epidural needles if it is shown to be suitable for continuous infusion in adults). Most of the risk factors for developing PDPH cannot be changed (e.g., younger age, female sex, low body mass index, history of migraines). However, epidural needle gauge is a modifiable risk factor. Evidence suggests that the use of smaller gauge epidural needles, like spinal needles, have the potential to reduce the incidence and severity of PDPH.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1081 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial Examining the Effect of Small Versus Large Tuohy-type Epidural Needles on the Incidence and Severity of Postdural Puncture Headache
Study Start Date : June 2007
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
19g needle, 23g catheter
Device: 19g Tuohy-type epidural needle, 23g catheter
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.
Other Names:
  • Health Canada Health Protection Branch (HPB) Licence # 6832
  • Smith's Medical epidural mini-kits 100/391/190
Active Comparator: 2
traditional =>18g needle
Device: => 18g Tuohy-type needle
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.
Other Names:
  • Hustead
  • Tuohy

Outcome Measures

Primary Outcome Measures :
  1. Incidence of postdural puncture headache [ Time Frame: within the first 14 days of epidural placement ]

Secondary Outcome Measures :
  1. PDPH characteristics (quality, distribution, postural versus non-postural nature, associated symptoms) [ Time Frame: within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement ]
  2. Severity of pain related to PDPH [ Time Frame: within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement ]
  3. Degree of dysfunction and disability related to PDPH symptoms [ Time Frame: within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement ]
  4. Duration of PDPH-related symptoms [ Time Frame: within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement ]
  5. 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 [ Time Frame: within 24 hours of epidural placement ]
  6. Incidence of persistent PDPH symptoms between groups [ Time Frame: at 6 weeks post-epidural placement ]
  7. Number and timing of epidural blood patches received, total number of epidural blood patches received until symptom resolution [ Time Frame: within the first 6 weeks of epidural placement ]
  8. Risk of delayed block failure for continuous labour analgesia in patients receiving a 19g Tuohy epidural needle and 23g catheter [ Time Frame: after first 30 minutes of successful initiation (requiring epidural reinsertion) ]
  9. Risk of requiring use of an alternative method of anesthesia for operative delivery in patients receiving successful epidural initiation with a 19g Tuohy epidural needle and a 23g catheter [ Time Frame: during labour and delivery ]
  10. Incidence of significant adverse events in each group [ Time Frame: up to 1 year post-epidural placement ]
  11. Patient ratings of overall pain relief compared between groups [ Time Frame: during labour and delivery ]
  12. Anesthesiologist satisfaction with the 19g Tuohy epidural needle and 23g catheter compared with traditional Tuohy type epidural needles and traditional catheters [ Time Frame: during labour and delivery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370604

Canada, British Columbia
British Columbia Women's Hospital and Health Centre
Vancouver, British Columbia, Canada, V6H 3N1
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3J 3G9
Canada, Ontario
St. Joseph's Hospital
London, Ontario, Canada, N6A 4V2
Sunnybrook Health Sciences Centre at Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
The Physicians' Services Incorporated Foundation
Canadian Anesthesiologists' Society
Principal Investigator: Pamela J Angle, MD, MSc Women's College Hospital at Sunnybrook Health Sciences Centre
More Information

Responsible Party: Dr. Pamela Angle, Associate Professor, Director, Associate Scientist, Anesthesiologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00370604     History of Changes
Other Study ID Numbers: 1-PAngle
First Posted: August 31, 2006    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

Keywords provided by Dr. Pamela Angle, Sunnybrook Health Sciences Centre:

Additional relevant MeSH terms:
Post-Dural Puncture Headache
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases