Combined Spinal-epidural Versus Spinal Analgesia for Elective Caesarean Section in the Postoperative Period

NCT ID: NCT02273011

Last Updated: 2014-10-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-05-31

Brief Summary

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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

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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

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Satisfaction Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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single shot spinal anesthesia

single shot spinal anesthesia for caesarean section was executed for anesthesia, oral analgesic medication was applicated for postoperative analgesia.

caesarean section

Intervention Type PROCEDURE

elective caesarean section under regional anesthesia

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.

caesarean section

Intervention Type PROCEDURE

elective caesarean section under regional anesthesia

Interventions

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caesarean section

elective caesarean section under regional anesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists-physical status: I or II
* elective caesarean section

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. med. Daniel Reuter

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Daniel Reuter

Vice Medical Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Daniel Reuter

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinukum Hamburg-Eppendorf

Locations

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Universitätsklinikum Hamburg-Eppendorf

Hamburg, City state of Hamburg, Germany

Site Status

Countries

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Germany

Other Identifiers

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CSEvsSSSA

Identifier Type: -

Identifier Source: org_study_id

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