Clinical trial NCT00370604: 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
Overall status: COMPLETED
Phase: NA
Conditions: Post-Dural Puncture Headache
Keywords: Parturient
Obstetrics
Pregnancy
Labour
Labor
Headache
Epidural
Analgesia
Anesthesia
Anaesthesia
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
name: Canadian Anesthesiologists' Society
First posted: 2006-08-31
Enrollment: 1081
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of postdural puncture headache
timeFrame: within the first 14 days of epidural placement
Secondary outcomes:
measure: PDPH characteristics (quality, distribution, postural versus non-postural nature, associated symptoms)
timeFrame: within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement
measure: Severity of pain related to PDPH
timeFrame: within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement
measure: Degree of dysfunction and disability related to PDPH symptoms
timeFrame: within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement
measure: Duration of PDPH-related symptoms
timeFrame: within first 14 days post-epidural placement, and if necessary, up to 1 year post-epidural placement
measure: 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
timeFrame: within 24 hours of epidural placement
measure: Incidence of persistent PDPH symptoms between groups
timeFrame: at 6 weeks post-epidural placement
measure: Number and timing of epidural blood patches received, total number of epidural blood patches received until symptom resolution
timeFrame: within the first 6 weeks of epidural placement
measure: Risk of delayed block failure for continuous labour analgesia in patients receiving a 19g Tuohy epidural needle and 23g catheter
timeFrame: after first 30 minutes of successful initiation (requiring epidural reinsertion)
measure: 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
timeFrame: during labour and delivery
measure: Incidence of significant adverse events in each group
timeFrame: up to 1 year post-epidural placement
measure: Patient ratings of overall pain relief compared between groups
timeFrame: during labour and delivery
measure: Anesthesiologist satisfaction with the 19g Tuohy epidural needle and 23g catheter compared with traditional Tuohy type epidural needles and traditional catheters
timeFrame: during labour and delivery
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Women's Hospital and Health Centre
state: British Columbia
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: London
country: Canada
facility: St. Joseph's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre at Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital at Sunnybrook Health Sciences Centre
name: Pamela J Angle, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.