Effects of; Anesthesia, Spinal and Epidural, in PregnancyNCT02617823
Influence of Maternal Postioning on Spread of Local Anesthetic After Epidural Analgesia
A study testing lateral position in people with Effects of; Anesthesia, Spinal and Epidural, in Pregnancy, run by Region Skane at 2 sites in Sweden.
Trial summary
The purpose of this study is to determine if a lateral positioning of the pregnant woman after epidural analgesia increases the incidence of unilateral functioning epidurals. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
- What is being tested?
- lateral position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 950 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2016to Dec 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all adult pregnant women recieiving epidural analgesia
Who cannot join
- participation refused
- inability to understand study purpose/instructions
- study postition could not be maintained for 30 min
- ineffective epidural
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
University Hospital SUS
Lund, Skåne County, 22185
University Hospital SUS
Malmö, Skåne County, 20502
About this study
The purpose of this study is to determine if a lateral positioning of the pregnant woman after epidural analgesia increases the incidence of unilateral functioning epidurals.
Read the detailed description
Pregnant women requesting epidural analgesia will be randomized to either left lateral or semi-recumbent position for 30 minutes after the first epidural bolus-injection.
After 30 minutes, the clinical effect of the analgesia will be evaluated by an anesthesiologist if available or by a midwife if the anesthesiologist is unavailable. The study-period is concluded thereafter and further positioning is optional.
Maternal and fetal wellbeing are continuously being monitored during the study period and complications/interventions registered. APGAR and CTG results during the intervention will be registered and evaluated at a later stage.
- Being tested
- lateral position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral positionProcedure or surgery
patients placed on their left side after epidural catheter insertion
| Study group | Role | What they receive |
|---|---|---|
| semi-recumbent | No intervention | rutine positioning at the hospital today |
| lateral position | Experimental | experimental position to be evaluated against rutine Receives: Procedure: lateral position |
What is being measured
The primary outcome is the main question the study is designed to answer.
unilateral analgesic effect
clinical judgement: mothers pain-sensation and cold sensation test
Measured: evaluation of epidural effect after 30 min
Secondary outcomes (2)
maternal comfort and safety in regards to blood pressure and/or unexpected neurological effects from epidural analgesia
clinical judgement: mothers subjective wellbeing, bloodpressure and incidence of vena cava compression, neurological deficits from epidural
Measured: evaluation of epidural effect after 30 min
fetal/neonatal safety measured with CTG and APGAR score
cardiotocographic changes and APGAR-score evaluation
Measured: CTG from start of study until birth, APGAR 2, 5 and 10min after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of; Anesthesia, Spinal and Epidural, in PregnancyStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 950 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Bansch, Region Skane
- Investigators
- Carolina Samuelsson, MD, PhD, Study chair, Region Skane, Head of the Department of Anesthesia and Intensive Care, University Hospital SUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617823
- Sponsor's protocol ID
- SUSAN-KK
- Status last verified
- Sep 2019
- First submitted
- 24 Nov 2015
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Maternal Postioning on Spread of Local Anesthetic After Epidural Analgesia
- ClinicalTrials.gov ID
- NCT02617823
- Acronym / sponsor ID
- SUSAN-KK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 950 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 1 Dec 2015 (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.
The purpose of this study is to determine if a lateral positioning of the pregnant woman after epidural analgesia increases the incidence of unilateral functioning epidurals.
Detailed description
Pregnant women requesting epidural analgesia will be randomized to either left lateral or semi-recumbent position for 30 minutes after the first epidural bolus-injection.
After 30 minutes, the clinical effect of the analgesia will be evaluated by an anesthesiologist if available or by a midwife if the anesthesiologist is unavailable. The study-period is concluded thereafter and further positioning is optional.
Maternal and fetal wellbeing are continuously being monitored during the study period and complications/interventions registered. APGAR and CTG results during the intervention will be registered and evaluated at a later stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| semi-recumbent | No intervention | –rutine positioning at the hospital today |
| lateral position | Experimental | Procedure: lateral positionexperimental position to be evaluated against rutine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all adult pregnant women recieiving epidural analgesia
Key exclusion criteria (4 listed)
- participation refused
- inability to understand study purpose/instructions
- study postition could not be maintained for 30 min
- ineffective epidural
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 |
|---|---|---|
| lateral positionpatients placed on their left side after epidural catheter insertion | Procedure or surgery | lateral position |
Primary outcome
unilateral analgesic effect
Time frame: evaluation of epidural effect after 30 min
clinical judgement: mothers pain-sensation and cold sensation test
2 secondary outcomes
maternal comfort and safety in regards to blood pressure and/or unexpected neurological effects from epidural analgesia
Time frame: evaluation of epidural effect after 30 min
fetal/neonatal safety measured with CTG and APGAR score
Time frame: CTG from start of study until birth, APGAR 2, 5 and 10min after birth
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 1 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Carolina Samuelsson, MD, PhD study chair
Region Skane, Head of the Department of Anesthesia and Intensive Care, University Hospital SUS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lateral position in people with Effects of; Anesthesia, Spinal and Epidural, in Pregnancy, run by Region Skane at 2 sites in Sweden.
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 1 inclusion and 4 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 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
unilateral analgesic effect (time frame: evaluation of epidural effect after 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2019.