Epidural Volume Extension During a Combined Spinal-Epidural Technique for Labor Analgesia.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ronald George, IWK Health Centre
ClinicalTrials.gov Identifier:
NCT01810406
First received: March 11, 2013
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Pregnancy
Labor Pain
Procedure: CSE with 10 ml EVE
Procedure: CSE without EVE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Epidural Volume Extension During a Combined Spinal-Epidural Technique for Labor Analgesia.

Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • Sensory dermatome level [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    As determined by non-traumatic pinprick test


Secondary Outcome Measures:
  • Analgesia [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    As assessed by numeric rating scale (NRS)

  • Motor block [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Assessed using a modified Bromage scale


Other Outcome Measures:
  • Side effects [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Includes hypotension, pruritus, nausea, fetal distress, and local anesthetic toxicity related side effects

  • Additional analgesia given [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Either self-administered by the patient via PCEA (Patient Controlled Epidural Analgesia) button, or administered by an anesthesiologist


Enrollment: 60
Study Start Date: March 2013
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epidural Volume Extension
CSE with 10 ml EVE
Procedure: CSE with 10 ml EVE
Combined Spinal-Epidural (CSE) with 10 ml Epidural Volume Extension (EVE)
Other Name: Normal Saline
Active Comparator: No Epidural Volume Extension
CSE without EVE
Procedure: CSE without EVE
Combined Spinal-Epidural (CSE) without Epidural Volume Extension (EVE)

Detailed Description:

Regional analgesia (pain relief) for labor can be an epidural, a spinal or a combination of the two. Combined spinal-epidurals (CSE) are popular because of their rapid pain relief and high patient satisfaction. At the IWK Health Centre, many anesthesiologists routinely use this method of pain relief. It involves the injection of pain relief medication into the cerebral spinal fluid (CSF) and the insertion of an epidural catheter (slim plastic tube) in the epidural space to continue to give pain relief medication. The epidural space is located just outside the CSF. In order to insert the epidural catheter, some anesthesiologists inject 2-4 ml of saline in the epidural space to help the catheter go in. 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).

Thus far, studies on EVE have all been done in patients undergoing surgery with spinal anesthesia and not solely for analgesia. The purpose of this study is to determine if there is a benefit for EVE to improve labor analgesia (pain relief) using CSE. We will study 60 women requesting labor pain relief. Half these women will receive a CSE without EVE, which is the present standard of care. The other half will receive a CSE with 10 ml of saline for EVE before inserting the epidural catheter. We will then determine if there is a benefit for EVE by observing for a difference between the two groups with respect to the level of numbness, the amount and speed of pain relief and the intensity of leg weakness. We hypothesize that injecting 10 ml of saline for EVE using CSE may improve the amount and speed of pain relief while decreasing side effects such as leg weakness. If there were a benefit to EVE, this would be a simple and inexpensive method for improving pain relief in laboring women.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01810406

Locations
Canada, Nova Scotia
Women's and Obstetric Anesthesia, IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
IWK Health Centre
Investigators
Principal Investigator: Valerie Zaphiratos, MSc MD FRCPC IWK Health Centre
Principal Investigator: Ronald B George, MD FRCPC IWK Health Centre
  More Information

No publications provided

Responsible Party: Ronald George, Principal Investigator, IWK Health Centre
ClinicalTrials.gov Identifier: NCT01810406     History of Changes
Other Study ID Numbers: IWK - 1013037
Study First Received: March 11, 2013
Last Updated: April 22, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014