Influence of Surgical Regional Anesthesia on Postoperative Pain
NCT ID: NCT01234662
Last Updated: 2012-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
171 participants
INTERVENTIONAL
2010-11-30
2012-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Spinal anesthesia + intrathecal opioid bolus (SPA)
SPA
Spinal anesthesia and opioids
Group 2
CSE + epidural opioid bolus (CSE)
CSE
CSE and epidural opioids
Group 3
CSE + continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs (CSEPCEA)
CSEPCEA
CSE and continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs
Interventions
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SPA
Spinal anesthesia and opioids
CSE
CSE and epidural opioids
CSEPCEA
CSE and continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Christian von Heymann, M.D.
Prof. Dr. med. Christian von Heymann, Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charite University, Berlin, Germany.
Principal Investigators
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Christian von Heymann, MD Prof.
Role: STUDY_DIRECTOR
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum
Locations
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Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Campus Charité Mitte, Charite University, Berlin
Berlin, State of Berlin, Germany
Countries
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Other Identifiers
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CESAR
Identifier Type: -
Identifier Source: org_study_id
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