PregnancyNCT01810406
Epidural Volume Extension During a Combined Spinal-Epidural Technique for Labor Analgesia.
A study testing CSE with 10 ml EVE and CSE without EVE in people with Pregnancy and Labor Pain, run by IWK Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Labor Pain
- What is being tested?
- CSE with 10 ml EVE and CSE without EVE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Women's and Obstetric Anesthesia, IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
About this study
Official title: A Randomized Controlled Trial of Epidural Volume Extension During a Combined Spinal-Epidural Technique for Labor Analgesia.
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.
Read the 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.
- Conditions
- Pregnancy, Labor Pain
- Being tested
- CSE with 10 ml EVE, CSE without EVE
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSE with 10 ml EVEProcedure or surgery
Also called Normal Saline
Combined Spinal-Epidural (CSE) with 10 ml Epidural Volume Extension (EVE)
CSE without EVEProcedure or surgery
Combined Spinal-Epidural (CSE) without Epidural Volume Extension (EVE)
| Study group | Role | What they receive |
|---|---|---|
| Epidural Volume Extension | Experimental | CSE with 10 ml EVE Receives: Procedure: CSE with 10 ml EVE |
| No Epidural Volume Extension | Active comparator | CSE without EVE Receives: Procedure: CSE without EVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory dermatome level
As determined by non-traumatic pinprick test
Measured: 30 minutes
Secondary outcomes (2)
Analgesia
As assessed by numeric rating scale (NRS)
Measured: 30 minutes
Motor block
Assessed using a modified Bromage scale
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald George, IWK Health Centre
- Investigators
- Valerie Zaphiratos, MSc MD FRCPC, Principal investigator, IWK Health CentreRonald B George, MD FRCPC, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810406
- Sponsor's protocol ID
- IWK - 1013037
- Status last verified
- Apr 2014
- First submitted
- 11 Mar 2013
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27088994
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Epidural Volume Extension During a Combined Spinal-Epidural Technique for Labor Analgesia.
- ClinicalTrials.gov ID
- NCT01810406
- Acronym / sponsor ID
- IWK - 1013037
- Conditions
- Pregnancy, Labor Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2014 (actual)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural Volume Extension | Experimental | Procedure: CSE with 10 ml EVECSE with 10 ml EVE |
| No Epidural Volume Extension | Active comparator | Procedure: CSE without EVECSE without EVE |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSE with 10 ml EVEAlso: Normal SalineCombined Spinal-Epidural (CSE) with 10 ml Epidural Volume Extension (EVE) | Procedure or surgery | Epidural Volume Extension |
| CSE without EVECombined Spinal-Epidural (CSE) without Epidural Volume Extension (EVE) | Procedure or surgery | No Epidural Volume Extension |
Primary outcome
Sensory dermatome level
Time frame: 30 minutes
As determined by non-traumatic pinprick test
2 secondary outcomes
Analgesia
Time frame: 30 minutes
Motor block
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2014.
- Derived from this study: PubMed 27088994Zaphiratos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Zaphiratos, MSc MD FRCPC principal investigator
IWK Health Centre
Ronald B George, MD FRCPC principal investigator
IWK Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSE with 10 ml EVE and CSE without EVE in people with Pregnancy and Labor Pain, run by IWK Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory dermatome level (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01810406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2014.