Epidural Volume Extension During a Combined Spinal-Epidural Technique for Labor Analgesia.
Primary Purpose
Pregnancy, Labor Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CSE with 10 ml EVE
CSE without EVE
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy
Eligibility 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
Sites / Locations
- Women's and Obstetric Anesthesia, IWK Health Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Epidural Volume Extension
No Epidural Volume Extension
Arm Description
CSE with 10 ml EVE
CSE without EVE
Outcomes
Primary Outcome Measures
Sensory dermatome level
As determined by non-traumatic pinprick test
Secondary Outcome Measures
Analgesia
As assessed by numeric rating scale (NRS)
Motor block
Assessed using a modified Bromage scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01810406
Brief Title
Epidural Volume Extension During a Combined Spinal-Epidural Technique for Labor Analgesia.
Official Title
A Randomized Controlled Trial of Epidural Volume Extension During a Combined Spinal-Epidural Technique for Labor Analgesia.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IWK Health Centre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Labor Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epidural Volume Extension
Arm Type
Experimental
Arm Description
CSE with 10 ml EVE
Arm Title
No Epidural Volume Extension
Arm Type
Active Comparator
Arm Description
CSE without EVE
Intervention Type
Procedure
Intervention Name(s)
CSE with 10 ml EVE
Other Intervention Name(s)
Normal Saline
Intervention Description
Combined Spinal-Epidural (CSE) with 10 ml Epidural Volume Extension (EVE)
Intervention Type
Procedure
Intervention Name(s)
CSE without EVE
Intervention Description
Combined Spinal-Epidural (CSE) without Epidural Volume Extension (EVE)
Primary Outcome Measure Information:
Title
Sensory dermatome level
Description
As determined by non-traumatic pinprick test
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Analgesia
Description
As assessed by numeric rating scale (NRS)
Time Frame
30 minutes
Title
Motor block
Description
Assessed using a modified Bromage scale
Time Frame
30 minutes
Other Pre-specified Outcome Measures:
Title
Side effects
Description
Includes hypotension, pruritus, nausea, fetal distress, and local anesthetic toxicity related side effects
Time Frame
30 minutes
Title
Additional analgesia given
Description
Either self-administered by the patient via PCEA (Patient Controlled Epidural Analgesia) button, or administered by an anesthesiologist
Time Frame
30 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Zaphiratos, MSc MD FRCPC
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronald B George, MD FRCPC
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's and Obstetric Anesthesia, IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
27088994
Citation
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.
Results Reference
derived
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Epidural Volume Extension During a Combined Spinal-Epidural Technique for Labor Analgesia.
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