CClinicalTrials.gg
CompletedNCT02273011Updated Oct 23, 2014

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

An observational study in Satisfaction and Pain, sponsored by Prof. Dr. med. Daniel Reuter. Completed at 1 site in Germany. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2014-10-23.

Sponsored by Prof. Dr. med. Daniel Reuter · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 50 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Satisfaction
  • Pain
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In context

Lead sponsor

This is the only study on the registry with Prof. Dr. med. Daniel Reuter as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

healthy parturients scheduled for elective caesarean section

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • Procedurecaesarean section

    elective caesarean section under regional anesthesia

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What researchers measure

Primary outcomes

  1. patient's satisfaction

    Standardised questionnaire assessing pain, discomfort, anxiety

    Time frame: perioperative

Secondary outcomes

  1. additional oral pain medication

    Assessment of additionally requested oral pain medication

    Time frame: perioperative

  2. pain score

    Standardised questionnaire assessing pain by using the visual analogue scale

    Time frame: perioperative

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Study locations

1 site
  • Universitätsklinikum Hamburg-Eppendorf
    Hamburg, 22085, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02273011
Lead sponsor
Prof. Dr. med. Daniel Reuter
Responsible party
Prof. Dr. med. Daniel Reuter (Vice Medical Director, Universitätsklinikum Hamburg-Eppendorf) — Sponsor-investigator
First posted
Oct 23, 2014
Start date
Mar 2007
Primary completion
May 2010
Completion
May 2010
Last update
Oct 23, 2014

Study contacts

Daniel Reuter
principal investigator · Universitätsklinukum Hamburg-Eppendorf

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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