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

October 21, 2014 updated by: Prof. Dr. med. Daniel Reuter
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 22085
        • Universitätsklinikum Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

healthy parturients scheduled for elective caesarean section

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
single shot spinal anesthesia
single shot spinal anesthesia for caesarean section was executed for anesthesia, oral analgesic medication was applicated for postoperative analgesia.
Procedure: caesarean section
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.
Procedure: caesarean section
elective caesarean section under regional anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient's satisfaction
Time Frame: perioperative
Standardised questionnaire assessing pain, discomfort, anxiety
perioperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
additional oral pain medication
Time Frame: perioperative
Assessment of additionally requested oral pain medication
perioperative
pain score
Time Frame: perioperative
Standardised questionnaire assessing pain by using the visual analogue scale
perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. med. Daniel Reuter

Investigators

  • Principal Investigator: Daniel Reuter, Universitätsklinukum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

January 15, 2014

First Submitted That Met QC Criteria

October 21, 2014

First Posted (Estimate)

October 23, 2014

Study Record Updates

Last Update Posted (Estimate)

October 23, 2014

Last Update Submitted That Met QC Criteria

October 21, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • CSEvsSSSA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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