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Completed

NCT Number: NCT00370604

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

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

British Columbia Women's Hospital and Health Centre, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

=> 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.

Other names: Hustead, Tuohy

Primary outcomes

  1. Incidence of postdural puncture headache

    Time frame: within the first 14 days of epidural placement

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Canadian Anesthesiologists' Society
  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

Randomized Controlled Trial Examining the Effect of Small Versus Large Tuohy-type Epidural Needles on the Incidence and Severity of Postdural Puncture Headache

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 31, 2006
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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