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

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).

Study Overview

• Status: Completed
• Conditions: Post-Dural Puncture Headache
• Intervention / Treatment: Device: 19g Tuohy-type epidural needle, 23g catheter; Device: => 18g Tuohy-type needle

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 Type: Interventional
• Enrollment (Actual): 1081
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • British Columbia Women's Hospital and Health Centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3J 3G9
      • IWK Health Centre
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St. Joseph's Hospital
    • Toronto, Ontario, Canada, M5S 1B2
      • Sunnybrook Health Sciences Centre at Women's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of postdural puncture headache	within the first 14 days of epidural placement

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Severity of pain related to PDPH	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
Duration of PDPH-related symptoms	within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement
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
Incidence of persistent PDPH symptoms between groups	at 6 weeks post-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)
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
Incidence of significant adverse events in each group	up to 1 year post-epidural placement
Patient ratings of overall pain relief compared between groups	during labour and delivery
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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: August 29, 2006
• First Submitted That Met QC Criteria: August 30, 2006
• First Posted (Estimate): August 31, 2006

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Pregnancy; Analgesia; Headache; Obstetrics; Epidural; Anesthesia; Anaesthesia; Labor; Labour; Parturient
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Dural Puncture Headache
• Other Study ID Numbers: 1-PAngle

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided