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

This study has been completed.
Sponsor:
Collaborators:
The Physicians' Services Incorporated Foundation
Canadian Anesthesiologists' Society
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00370604
First received: August 29, 2006
Last updated: January 12, 2011
Last verified: January 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Incidence of postdural puncture headache [ Time Frame: within the first 14 days of epidural placement ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Duration of PDPH-related symptoms [ Time Frame: within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of persistent PDPH symptoms between groups [ Time Frame: at 6 weeks post-epidural placement ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Incidence of significant adverse events in each group [ Time Frame: up to 1 year post-epidural placement ] [ Designated as safety issue: Yes ]
  • Patient ratings of overall pain relief compared between groups [ Time Frame: during labour and delivery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 3100
Study Start Date: June 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370604

Locations
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
Investigators
Principal Investigator: Pamela J Angle, MD, MSc Women's College Hospital at Sunnybrook Health Sciences Centre
  More Information

Publications:
Responsible Party: Pamela Angle, MD, Women's College Hospital at Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00370604     History of Changes
Other Study ID Numbers: 1-PAngle
Study First Received: August 29, 2006
Last Updated: January 12, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Parturient
Obstetrics
Pregnancy
Labour
Labor
Headache
Epidural
Analgesia
Anesthesia
Anaesthesia

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

ClinicalTrials.gov processed this record on November 24, 2014