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

NCT02273011 | Completed

• 1 other identifier: CSEvsSSSA
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Satisfaction; Pain

Outcome Measures

Primary Outcomes (1)

• patient's satisfaction

  Standardised questionnaire assessing pain, discomfort, anxiety

  perioperative

Secondary Outcomes (2)

• additional oral pain medication

  perioperative

• pain score

  perioperative

Study Arms (2)

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

caesarean section PROCEDURE

elective caesarean section under regional anesthesia

combuned spinal epidural anesthesia; single shot spinal anesthesia

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

healthy parturients scheduled for elective caesarean section

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. med. Daniel Reuter: lead

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Hamburg, 22085, Germany

Location

MeSH Terms

Conditions

Personal Satisfaction; Pain

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Daniel Reuter

  Universitätsklinukum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Medical Director

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: October 23, 2014
• Study Start: March 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 23, 2014

Record last verified: 2014-10

Locations

DE (1)