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Post-Dural Puncture HeadacheNCT00370604

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

A study testing 19g Tuohy-type epidural needle, 23g catheter and => 18g Tuohy-type needle in people with Post-Dural Puncture Headache, run by Sunnybrook Health Sciences Centre at 4 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Post-Dural Puncture Headache
What is being tested?
19g Tuohy-type epidural needle, 23g catheter and => 18g Tuohy-type needle
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,081 participants
Where
4 sitesCanada
Study dates
Jun 2007to Dec 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • IWK Health Centre

    Halifax, Nova Scotia, B3J 3G9

  • St. Joseph's Hospital

    London, Ontario, N6A 4V2

  • Sunnybrook Health Sciences Centre at Women's College Hospital

    Toronto, Ontario, M5S 1B2

  • British Columbia Women's Hospital and Health Centre

    Vancouver, British Columbia, V6H 3N1

Other trials in Canada

About this study

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

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).

Read the 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.

Being tested
19g Tuohy-type epidural needle, 23g catheter, => 18g Tuohy-type needle
Keywords
Parturient, Obstetrics, Pregnancy, Labour, Labor, Headache, Epidural, Analgesia, Anesthesia, Anaesthesia
Medical subject headings
Post-Dural Puncture Headache, Headache, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 19g Tuohy-type epidural needle, 23g catheterDevice

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

    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.

  • => 18g Tuohy-type needleDevice

    Also called Hustead, Tuohy

    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.

Study groups in NCT00370604
Study groupRoleWhat they receive
1Experimental19g needle, 23g catheter
Receives: Device: 19g Tuohy-type epidural needle, 23g catheter
2Active comparatortraditional =>18g needle
Receives: Device: => 18g Tuohy-type needle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of postdural puncture headache

    Measured: within the first 14 days of epidural placement

Secondary outcomes (12)

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

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

  2. Severity of pain related to PDPH

    Measured: 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

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

  4. Duration of PDPH-related symptoms

    Measured: 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

    Measured: within 24 hours of epidural placement

  6. Incidence of persistent PDPH symptoms between groups

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: during labour and delivery

  10. Incidence of significant adverse events in each group

    Measured: up to 1 year post-epidural placement

  11. Patient ratings of overall pain relief compared between groups

    Measured: 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

    Measured: during labour and delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2006 (estimated)
  2. Study startJun 2007
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,081 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00370604
Sponsor's protocol ID
1-PAngle
Status last verified
Jun 2022
First submitted
29 Aug 2006
Last updated
9 Jun 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 16527791

Questions about this trial

What is this clinical trial studying?

A study testing 19g Tuohy-type epidural needle, 23g catheter and => 18g Tuohy-type needle in people with Post-Dural Puncture Headache, run by Sunnybrook Health Sciences Centre at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of postdural puncture headache (time frame: within the first 14 days of epidural placement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00370604, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.

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