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

NCT ID: NCT00370604

Last Updated: 2022-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1081 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-12-31

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.

Conditions

Post-Dural Puncture Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

19g needle, 23g catheter

Group Type: EXPERIMENTAL

19g Tuohy-type epidural needle, 23g catheter

Intervention Type: DEVICE

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.

2

traditional =\>18g needle

Group Type: ACTIVE_COMPARATOR

=> 18g Tuohy-type needle

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Health Canada Health Protection Branch (HPB) Licence # 6832; Smith's Medical epidural mini-kits 100/391/190; Hustead; Tuohy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

Canadian Anesthesiologists' Society

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Pamela Angle

Associate Professor, Director, Associate Scientist, Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pamela J Angle, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital at Sunnybrook Health Sciences Centre

Locations

British Columbia Women's Hospital and Health Centre

Vancouver, British Columbia, 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

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 16527791 (View on PubMed)

Other Identifiers

1-PAngle

Identifier Type: -

Identifier Source: org_study_id