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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02273011
• Other study ID #: CSEvsSSSA
• 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

• Pain
• Satisfaction

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