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

Completed

• Conditions: Satisfaction; Pain
• Interventions: Procedure: caesarean section

• Registration Number: NCT02273011
• Lead Sponsor: Prof. Dr. med. Daniel Reuter

Brief 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.

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 Timeline

• Study Start: 2007-03
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Study First Submitted: 2014-01-15
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-21
• Last Update Submitted: 2014-10-21
• Study First Posted: 2014-10-23
• Last Update Posted: 2014-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
single shot spinal anesthesia	caesarean section	single shot spinal anesthesia for caesarean section was executed for anesthesia, oral analgesic medication was applicated for postoperative analgesia.
combuned spinal epidural anesthesia	caesarean section	combined spinal epidural anesthesia for caesarean section was executed for anesthesia, epidural and oral analgesic medication was applicated for postoperative analgesia.

Primary Outcome Measures

Name	Time	Method
patient's satisfaction	perioperative	Standardised questionnaire assessing pain, discomfort, anxiety

Secondary Outcome Measures

Name	Time	Method
additional oral pain medication	perioperative	Assessment of additionally requested oral pain medication
pain score	perioperative	Standardised questionnaire assessing pain by using the visual analogue scale

Trial Locations

Locations (1)

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany