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

Post-Dural Puncture Headache Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370604
• Other study ID #: 1-PAngle
• Status: Completed
• Phase: N/A
• Start date: June 2007
• Est. completion date: December 2009

Study information

• Verified date: June 2022
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1081
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache

Intervention

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.
• => 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.

Locations

Country	Name	City	State
Canada	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

Sponsors (3)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Anesthesiologists' Society, The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postdural puncture headache		within the first 14 days of epidural placement
Secondary	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
Secondary	Severity of pain related to PDPH		within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement
Secondary	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
Secondary	Duration of PDPH-related symptoms		within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement
Secondary	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
Secondary	Incidence of persistent PDPH symptoms between groups		at 6 weeks post-epidural placement
Secondary	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
Secondary	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)
Secondary	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
Secondary	Incidence of significant adverse events in each group		up to 1 year post-epidural placement
Secondary	Patient ratings of overall pain relief compared between groups		during labour and delivery
Secondary	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