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

Not Applicable

Completed

• Conditions: Post-Dural Puncture Headache
• Interventions: Device: => 18g Tuohy-type needle; Device: 19g Tuohy-type epidural needle, 23g catheter

• Registration Number: NCT00370604
• Lead Sponsor: Sunnybrook Health Sciences Centre

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).

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 Timeline

• Study First Submitted: 2006-08-29
• Study First Submitted QC: 2006-08-30
• Study First Posted: 2006-08-31
• Study Start: 2007-06
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1081

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	=> 18g Tuohy-type needle	traditional =\>18g needle
1	19g Tuohy-type epidural needle, 23g catheter	19g needle, 23g catheter

Primary Outcome Measures

Name	Time	Method
Incidence of postdural puncture headache	within the first 14 days of epidural placement

Secondary Outcome Measures

Name	Time	Method
Duration of PDPH-related symptoms	within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement
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	during labour and delivery
Severity of pain related to PDPH	within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement
Incidence of persistent PDPH symptoms between groups	at 6 weeks post-epidural placement
Patient ratings of overall pain relief compared between groups	during labour and delivery
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
Number and timing of epidural blood patches received, total number of epidural blood patches received until symptom resolution	within the first 6 weeks of epidural placement
Risk of delayed block failure for continuous labour analgesia in patients receiving a 19g Tuohy epidural needle and 23g catheter	after first 30 minutes of successful initiation (requiring epidural reinsertion)
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
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
Incidence of significant adverse events in each group	up to 1 year post-epidural placement
Anesthesiologist satisfaction with the 19g Tuohy epidural needle and 23g catheter compared with traditional Tuohy type epidural needles and traditional catheters	during labour and delivery

Trial Locations

Locations (4)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada

St. Joseph's Hospital; 🇨🇦 London, Ontario, Canada

Sunnybrook Health Sciences Centre at Women's College Hospital; 🇨🇦 Toronto, Ontario, Canada

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