NCT01810406

Brief Summary

Combined spinal-epidurals (CSE) involve the injection of pain relief medication into the cerebral spinal fluid (CSF) and the insertion of an epidural catheter in the epidural space to continue to give pain relief medication. During a CSE, after injection of the medication in the CSF and before inserting the epidural catheter, if normal saline is injected into the epidural space, there may be an increase in pain relief and an increase in the level of numbness. This injection of saline in the epidural space to increase pain relief and numbness is termed epidural volume extension (EVE). The purpose of this study is to determine if there is a benefit for EVE to improve labor analgesia (pain relief) using CSE in pregnant laboring patients.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Last Updated

April 23, 2014

Status Verified

April 1, 2014

Enrollment Period

1.1 years

First QC Date

March 11, 2013

Last Update Submit

April 22, 2014

Conditions

PregnancyLabor Pain

Outcome Measures

Primary Outcomes (1)

  • Sensory dermatome level

    As determined by non-traumatic pinprick test

    30 minutes

Secondary Outcomes (2)

  • Analgesia

    30 minutes

  • Motor block

    30 minutes

Other Outcomes (2)

  • Side effects

    30 minutes

  • Additional analgesia given

    30 minutes

Study Arms (2)

Epidural Volume Extension

EXPERIMENTAL

CSE with 10 ml EVE

Procedure: CSE with 10 ml EVE

No Epidural Volume Extension

ACTIVE COMPARATOR

CSE without EVE

Procedure: CSE without EVE

Interventions

CSE with 10 ml EVEPROCEDURE

Combined Spinal-Epidural (CSE) with 10 ml Epidural Volume Extension (EVE)

Also known as: Normal Saline
Epidural Volume Extension
CSE without EVEPROCEDURE

Combined Spinal-Epidural (CSE) without Epidural Volume Extension (EVE)

No Epidural Volume Extension

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nulliparous parturients requesting regional analgesia for labour pain with singleton, vertex presentation fetuses at 37-42 week gestation in active labor with cervical dilation \< 5 cm.
  • American Society of Anesthesia physical status class I \& II (ASA I - Healthy, ASA II - mild and controlled systemic disease, e.g. controlled essential hypertension)
  • Age ≥ 18 years (Standard within the obstetrical anesthesia literature)
  • English-speaking

You may not qualify if:

  • Contraindications to neuraxial analgesia (i.e. coagulopathy, systemic infection, neuropathy)
  • Conditions associated with abnormal spinal anatomy which can affect local anesthetic spread (i.e. scoliosis, spina bifida, spinal instrumentation)
  • Conditions associated with an increased risk of a cesarean delivery (i.e., history of uterine anomaly or surgery, morbid obesity (Body Mass Index ≥ 35 kg/m2)
  • Clinically significant diseases of pregnancy such as pregnancy-induced hypertension or preeclampsia (defined as systolic blood pressure (SBP) \> 160mmHg, diastolic blood pressure (DBP) \> 110mmHg and/or requiring antihypertensive treatment or associated with significant proteinuria)
  • Severe maternal cardiac disease
  • Known fetal anomalies /intrauterine fetal demise
  • Patient enrollment in another study involving a study medication within 30 days
  • Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's and Obstetric Anesthesia, IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Publications (1)

  • Zaphiratos V, George RB, Macaulay B, Bolleddula P, McKeen DM. Epidural Volume Extension During Combined Spinal-Epidural Labor Analgesia Does Not Increase Sensory Block. Anesth Analg. 2016 Sep;123(3):684-9. doi: 10.1213/ANE.0000000000001281.

    PMID: 27088994DERIVED

MeSH Terms

Conditions

Labor Pain

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Valerie Zaphiratos, MSc MD FRCPC

    IWK Health Centre

    PRINCIPAL INVESTIGATOR

  • Ronald B George, MD FRCPC

    IWK Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 13, 2013

Study Start

March 1, 2013

Primary Completion

April 1, 2014

Last Updated

April 23, 2014

Record last verified: 2014-04

Locations

CA(1)