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Completed

NCT Number: NCT02273011

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

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.

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Key information

Conditions

Satisfaction Behavior Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Personal Satisfaction Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 22085, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caesarean section

Procedure

elective caesarean section under regional anesthesia

Primary outcomes

  1. patient's satisfaction

    Time frame: perioperative

    Standardised questionnaire assessing pain, discomfort, anxiety

Secondary outcomes

  1. additional oral pain medication

    Time frame: perioperative

    Assessment of additionally requested oral pain medication

  2. pain score

    Time frame: perioperative

    Standardised questionnaire assessing pain by using the visual analogue scale

Sponsors and collaborators

Lead sponsor

Prof. Dr. med. Daniel Reuter

Other

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 23, 2014
Registry last updated
Oct 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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