Elective Cesarean SectionCESARNCT01234662
Influence of Surgical Regional Anesthesia on Postoperative Pain
A study testing SPA, CSE and CSEPCEA in people with Elective Cesarean Section, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
To compare three Types of anesthetic techniques (Spinal anesthesia, Combined spinal epidural anesthesia, Combined spinal epidural anesthesia with indwelling catheter for 24 hrs) on pain after elective cesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Elective Cesarean Section
- What is being tested?
- SPA, CSE and CSEPCEA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Dec 2012
- 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
- Female patients aged greater than or equal to 18 years
- Patients without severe illnesses (American Society of Anaesthesiologists [ASA] grade II-III)
- Patients for elective cesarean sections
- Informing patients about risks and complications of anesthesia until 24 hrs before operation
Who cannot join
- Lacking willingness to regional procedures
- No offered patient information and written informed consent
- Persons without the capacity to consent
- Unability of German language use
- Preterm delivery < 28 weeks of pregnancy
- Chronic pain or chronic analgesic intake in medical history
Show all 15Show fewer
- Alcohol, dope and medication abuse
- Psychiatric disease in medical history
- Baby death after delivery
- Anxiolytic medication
- Allergy to local anaesthetics
- History of bleeding tendency
- Eclampsia and HELLP syndrome
- Elective section out work routine time
- Participation in another clinical trial during the trial, one month before screening and three months after screening
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Campus Charité Mitte, Charite University, Berlin
Berlin, State of Berlin, 13353
About this study
Official title: Combined Spinal Epidural Anesthesia (CSE) vs Spinal Anesthesia for Elective Cesarean Sections. Influence of Surgical Regional Anesthesia on Postoperative Pain
To compare three Types of anesthetic techniques (Spinal anesthesia, Combined spinal epidural anesthesia, Combined spinal epidural anesthesia with indwelling catheter for 24 hrs) on pain after elective cesarean section.
Read the detailed description
Regional analgesia is the most effective way of providing analgesia during labor and delivery. By using a combination of local anesthetics and opioids, it is often possible to avoid motor block. Spinal anesthesia is suitable for most elective cesarean sections. Epidural anesthesia and in particular catheter based epidural anesthesia allow a gradual extension of anesthesia and are suitable for prolonged treatment of postoperative pain.
It is unclear which anesthetic technique provides better pain relief after cesarean section.
This prospective, randomized study compares the effectiveness of three types of regional anesthetic techniques (Spinal anesthesia, Combined spinal epidural anesthesia, Combined spinal epidural anesthesia with indwelling catheter for 24 hrs) on pain after elective cesarean section.
- Conditions
- Elective Cesarean Section
- Being tested
- SPA, CSE, CSEPCEA
- Keywords
- Elective cesarean sections, Postoperative pain level, Spinal anesthesia, Combined spinal epidural anesthesia, Epidural catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPAProcedure or surgery
Spinal anesthesia and opioids
CSEProcedure or surgery
CSE and epidural opioids
CSEPCEAProcedure or surgery
CSE and continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Spinal anesthesia + intrathecal opioid bolus (SPA) Receives: Procedure: SPA |
| Group 2 | Active comparator | CSE + epidural opioid bolus (CSE) Receives: Procedure: CSE |
| Group 3 | Experimental | CSE + continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs (CSEPCEA) Receives: Procedure: CSEPCEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain levels during movement (cough)
Patient self-assessed postoperative pain levels during movement (cough) using an unmarked zero to one hundred mm visual analog scale (VAS)
Measured: At nine hours after the end of surgery (closure time)
Secondary outcomes (10)
Postoperative pain levels during rest
Patient self-assessed postoperative pain levels during rest using an unmarked zero to one hundred mm visual analog scale (VAS)
Measured: At nine hours after the end of surgery (closure time)
Postoperative pain levels during rest and movement
Patient self-assessed postoperative pain levels during rest and movement using an unmarked zero to one hundred mm visual analog scale (VAS)
Measured: At zero (injection), one, two, six, nine, twenty four, fourty eight hours after the end of surgery (closure time)
Change of type of anesthesia when regional anesthesia fails
Measured: During the operation
Level of anesthesia during the operation
Measured: During the operation
Incidence of hypotensions during the operation
Measured: During the operation
Sedation level (Ramsay-Score)
Measured: Postoperative course
Capability for mobilisation and time to first mobilisation
Measured: Postoperative course
Incidence of adverse reactions (PONV, headache and backpain, urinary retention)
Measured: Postoperative course
Satisfaction with pain management
Measured: Postoperative course
Co-analgesics
Co-analgesic consumption
Measured: In the 48-hour postoperative sample period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2012
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- None (open label)
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian von Heymann, M.D., Charite University, Berlin, Germany
- Investigators
- Christian von Heymann, MD Prof., Study director, Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234662
- Sponsor's protocol ID
- CESAR
- Acronym
- CESAR
- Status last verified
- May 2012
- First submitted
- 3 Nov 2010
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Spinal Epidural Anesthesia (CSE) vs Spinal Anesthesia for Elective Cesarean Sections. Influence of Surgical Regional Anesthesia on Postoperative Pain
- ClinicalTrials.gov ID
- NCT01234662
- Acronym / sponsor ID
- CESAR / CESAR
- Conditions
- Elective Cesarean Section
- Keywords
- Elective cesarean sections, Postoperative pain level, Spinal anesthesia, Combined spinal epidural anesthesia, Epidural catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 4 Nov 2010 (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.
To compare three Types of anesthetic techniques (Spinal anesthesia, Combined spinal epidural anesthesia, Combined spinal epidural anesthesia with indwelling catheter for 24 hrs) on pain after elective cesarean section.
Detailed description
Regional analgesia is the most effective way of providing analgesia during labor and delivery. By using a combination of local anesthetics and opioids, it is often possible to avoid motor block. Spinal anesthesia is suitable for most elective cesarean sections. Epidural anesthesia and in particular catheter based epidural anesthesia allow a gradual extension of anesthesia and are suitable for prolonged treatment of postoperative pain.
It is unclear which anesthetic technique provides better pain relief after cesarean section.
This prospective, randomized study compares the effectiveness of three types of regional anesthetic techniques (Spinal anesthesia, Combined spinal epidural anesthesia, Combined spinal epidural anesthesia with indwelling catheter for 24 hrs) on pain after elective cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: SPASpinal anesthesia + intrathecal opioid bolus (SPA) |
| Group 2 | Active comparator | Procedure: CSECSE + epidural opioid bolus (CSE) |
| Group 3 | Experimental | Procedure: CSEPCEACSE + continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs (CSEPCEA) |
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)
- Female patients aged greater than or equal to 18 years
- Patients without severe illnesses (American Society of Anaesthesiologists [ASA] grade II-III)
- Patients for elective cesarean sections
- Informing patients about risks and complications of anesthesia until 24 hrs before operation
Key exclusion criteria (15 listed)
- Lacking willingness to regional procedures
- No offered patient information and written informed consent
- Persons without the capacity to consent
- Unability of German language use
- Preterm delivery < 28 weeks of pregnancy
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 |
|---|---|---|
| SPASpinal anesthesia and opioids | Procedure or surgery | Group 1 |
| CSECSE and epidural opioids | Procedure or surgery | Group 2 |
| CSEPCEACSE and continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs | Procedure or surgery | Group 3 |
Primary outcome
Postoperative pain levels during movement (cough)
Time frame: At nine hours after the end of surgery (closure time)
Patient self-assessed postoperative pain levels during movement (cough) using an unmarked zero to one hundred mm visual analog scale (VAS)
10 secondary outcomes
Postoperative pain levels during rest
Time frame: At nine hours after the end of surgery (closure time)
Postoperative pain levels during rest and movement
Time frame: At zero (injection), one, two, six, nine, twenty four, fourty eight hours after the end of surgery (closure time)
Change of type of anesthesia when regional anesthesia fails
Time frame: During the operation
Level of anesthesia during the operation
Time frame: During the operation
Incidence of hypotensions during the operation
Time frame: During the operation
Sedation level (Ramsay-Score)
Time frame: Postoperative course
Capability for mobilisation and time to first mobilisation
Time frame: Postoperative course
Incidence of adverse reactions (PONV, headache and backpain, urinary retention)
Time frame: Postoperative course
Satisfaction with pain management
Time frame: Postoperative course
Co-analgesics
Time frame: In the 48-hour postoperative sample period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
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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.
Christian von Heymann, MD Prof. study director
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPA, CSE and CSEPCEA in people with Elective Cesarean Section, run by Charite University, Berlin, Germany 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 4 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 1 Jun 2012. 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?
Results are not available in the source record.
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?
Postoperative pain levels during movement (cough) (time frame: At nine hours after the end of surgery (closure time)). 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 Jun 2012.