search
Back to results

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

Primary Purpose

Post-Dural Puncture Headache

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
19g Tuohy-type epidural needle, 23g catheter
=> 18g Tuohy-type needle
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-Dural Puncture Headache focused on measuring Parturient, Obstetrics, Pregnancy, Labour, Labor, Headache, Epidural, Analgesia, Anesthesia, Anaesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • British Columbia Women's Hospital and Health Centre
  • IWK Health Centre
  • St. Joseph's Hospital
  • Sunnybrook Health Sciences Centre at Women's College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

19g needle, 23g catheter

traditional =>18g needle

Outcomes

Primary Outcome Measures

Incidence of postdural puncture headache

Secondary Outcome Measures

PDPH characteristics (quality, distribution, postural versus non-postural nature, associated symptoms)
Severity of pain related to PDPH
Degree of dysfunction and disability related to PDPH symptoms
Duration of PDPH-related symptoms
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
Incidence of persistent PDPH symptoms between groups
Number and timing of epidural blood patches received, total number of epidural blood patches received until symptom resolution
Risk of delayed block failure for continuous labour analgesia in patients receiving a 19g Tuohy epidural needle and 23g catheter
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
Incidence of significant adverse events in each group
Patient ratings of overall pain relief compared between groups
Anesthesiologist satisfaction with the 19g Tuohy epidural needle and 23g catheter compared with traditional Tuohy type epidural needles and traditional catheters

Full Information

First Posted
August 29, 2006
Last Updated
June 8, 2022
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
The Physicians' Services Incorporated Foundation, Canadian Anesthesiologists' Society
search

1. Study Identification

Unique Protocol Identification Number
NCT00370604
Brief Title
Effect of Small Versus Large Epidural Needles on Postdural Puncture Headache 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
The Physicians' Services Incorporated Foundation, Canadian Anesthesiologists' Society

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Dural Puncture Headache
Keywords
Parturient, Obstetrics, Pregnancy, Labour, Labor, Headache, Epidural, Analgesia, Anesthesia, Anaesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1081 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
19g needle, 23g catheter
Arm Title
2
Arm Type
Active Comparator
Arm Description
traditional =>18g needle
Intervention Type
Device
Intervention Name(s)
19g Tuohy-type epidural needle, 23g catheter
Other Intervention Name(s)
Health Canada Health Protection Branch (HPB) Licence # 6832, Smith's Medical epidural mini-kits 100/391/190
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
=> 18g Tuohy-type needle
Other Intervention Name(s)
Hustead, Tuohy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of postdural puncture headache
Time Frame
within the first 14 days of epidural placement
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Duration of PDPH-related symptoms
Time Frame
within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement
Title
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
Title
Incidence of persistent PDPH symptoms between groups
Time Frame
at 6 weeks post-epidural placement
Title
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
Title
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)
Title
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
Title
Incidence of significant adverse events in each group
Time Frame
up to 1 year post-epidural placement
Title
Patient ratings of overall pain relief compared between groups
Time Frame
during labour and delivery
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela J Angle, MD, MSc
Organizational Affiliation
Women's College Hospital at Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Columbia Women's Hospital and Health Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3J 3G9
Country
Canada
Facility Name
St. Joseph's Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre at Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16527791
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs