SatisfactionNCT02273011
Combined Spinal-epidural Versus Spinal Analgesia for Elective Caesarean Section in the Postoperative Period
An observational study of Satisfaction and Pain, run by Prof. Dr. med. Daniel Reuter at 1 site in Germany.
Trial summary
Combined spinal epidural (CSEA) and single shot spinal anesthesia (SSSA) are both well-established anesthetic methods for caesarean section. CSEA combines the advantages of spinal anesthesia for the surgery, and epidural anesthesia for postoperative pain management. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Satisfaction, Pain
- What is being tested?
- caesarean section
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2007to May 2010
- Phase
- Observational
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: healthy parturients scheduled for elective caesarean section
Who may be able to join
- American Society of Anesthesiologists-physical status: I or II
- elective caesarean section
Who cannot join
- age under eighteen
- maternal systemic diseases
- allergies against the drugs used
- systemic infection or local infection in the puncture area
- dysfunctional coagulation
- coagulation-inhibiting drugs
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 22085
About this study
Combined spinal epidural (CSEA) and single shot spinal anesthesia (SSSA) are both well-established anesthetic methods for caesarean section. CSEA combines the advantages of spinal anesthesia for the surgery, and epidural anesthesia for postoperative pain management. The aim of this randomized trial was to compare analgesia and patient satisfaction with CSEA continuous epidural administration of local anesthetics versus SSSA with oral pain medication in the postoperative period.
Read the detailed description
Combined spinal epidural (CSEA) and single shot spinal anesthesia (SSSA) are both well-established anesthetic methods for caesarean section. CSEA combines the advantages of spinal anesthesia for the surgery, and epidural anesthesia for postoperative pain management. However, it is more time-consuming, and adds potentially risks of both single techniques.
The aim of this randomized trial was to compare analgesia and patient satisfaction with CSEA continuous epidural administration of local anesthetics versus SSSA with oral pain medication in the postoperative period.
- Conditions
- Satisfaction, Pain
- Being tested
- caesarean section
- Medical subject headings
- Personal Satisfaction, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caesarean sectionProcedure or surgery
elective caesarean section under regional anesthesia
| Study group | Role | What they receive |
|---|---|---|
| single shot spinal anesthesia | single shot spinal anesthesia for caesarean section was executed for anesthesia, oral analgesic medication was applicated for postoperative analgesia. Receives: Procedure: caesarean section | |
| combuned spinal epidural anesthesia | combined spinal epidural anesthesia for caesarean section was executed for anesthesia, epidural and oral analgesic medication was applicated for postoperative analgesia. Receives: Procedure: caesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient's satisfaction
Standardised questionnaire assessing pain, discomfort, anxiety
Measured: perioperative
Secondary outcomes (2)
additional oral pain medication
Assessment of additionally requested oral pain medication
Measured: perioperative
pain score
Standardised questionnaire assessing pain by using the visual analogue scale
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startMar 2007
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SatisfactionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Daniel Reuter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Daniel Reuter, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Daniel Reuter, Principal investigator, Universitätsklinukum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273011
- Sponsor's protocol ID
- CSEvsSSSA
- Status last verified
- Oct 2014
- First submitted
- 15 Jan 2014
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Spinal-epidural Versus Spinal Analgesia for Elective Caesarean Section in the Postoperative Period
- ClinicalTrials.gov ID
- NCT02273011
- Acronym / sponsor ID
- CSEvsSSSA
- Conditions
- Satisfaction, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Prof. Dr. med. Daniel ReuterUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 23 Oct 2014 (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 epidural (CSEA) and single shot spinal anesthesia (SSSA) are both well-established anesthetic methods for caesarean section. CSEA combines the advantages of spinal anesthesia for the surgery, and epidural anesthesia for postoperative pain management. The aim of this randomized trial was to compare analgesia and patient satisfaction with CSEA continuous epidural administration of local anesthetics versus SSSA with oral pain medication in the postoperative period.
Detailed description
Combined spinal epidural (CSEA) and single shot spinal anesthesia (SSSA) are both well-established anesthetic methods for caesarean section. CSEA combines the advantages of spinal anesthesia for the surgery, and epidural anesthesia for postoperative pain management. However, it is more time-consuming, and adds potentially risks of both single techniques.
The aim of this randomized trial was to compare analgesia and patient satisfaction with CSEA continuous epidural administration of local anesthetics versus SSSA with oral pain medication in the postoperative period.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single shot spinal anesthesia | – | Procedure: caesarean sectionsingle shot spinal anesthesia for caesarean section was executed for anesthesia, oral analgesic medication was applicated for postoperative analgesia. |
| combuned spinal epidural anesthesia | – | Procedure: caesarean sectioncombined spinal epidural anesthesia for caesarean section was executed for anesthesia, epidural and oral analgesic medication was applicated for postoperative analgesia. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- healthy parturients scheduled for elective caesarean section
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists-physical status: I or II
- elective caesarean section
Key exclusion criteria (6 listed)
- age under eighteen
- maternal systemic diseases
- allergies against the drugs used
- systemic infection or local infection in the puncture area
- dysfunctional coagulation
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 |
|---|---|---|
| caesarean sectionelective caesarean section under regional anesthesia | Procedure or surgery | combuned spinal epidural anesthesia, single shot spinal anesthesia |
Primary outcome
patient's satisfaction
Time frame: perioperative
Standardised questionnaire assessing pain, discomfort, anxiety
2 secondary outcomes
additional oral pain medication
Time frame: perioperative
pain score
Time frame: perioperative
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 Oct 2014.
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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.
Daniel Reuter principal investigator
Universitätsklinukum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Satisfaction and Pain, run by Prof. Dr. med. Daniel Reuter at 1 site in Germany.
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 2 inclusion and 6 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 Oct 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 Germany. 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?
patient's satisfaction (time frame: perioperative). 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 23 Oct 2014.