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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02273011
Other study ID # CSEvsSSSA
Secondary ID
Status Completed
Phase N/A
First received January 15, 2014
Last updated October 21, 2014
Start date March 2007
Est. completion date May 2010

Study information

Verified date October 2014
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
caesarean section
elective caesarean section under regional anesthesia

Locations

Country Name City State
Germany Universitätsklinikum Hamburg-Eppendorf Hamburg

Sponsors (1)

Lead Sponsor Collaborator
Prof. Dr. med. Daniel Reuter

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary patient's satisfaction Standardised questionnaire assessing pain, discomfort, anxiety perioperative No
Secondary additional oral pain medication Assessment of additionally requested oral pain medication perioperative No
Secondary pain score Standardised questionnaire assessing pain by using the visual analogue scale perioperative No
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