NCT01234662

Brief Summary

To compare three Types of anesthetic techniques (Spinal anesthesia, Combined spinal epidural anesthesia, Combined spinal epidural anesthesia with indwelling catheter for 24 hrs) on pain after elective cesarean section.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 1, 2012

Status Verified

May 1, 2012

Enrollment Period

1.4 years

First QC Date

November 3, 2010

Last Update Submit

May 31, 2012

Conditions

Elective Cesarean Section

Keywords

Elective cesarean sectionsPostoperative pain levelSpinal anesthesiaCombined spinal epidural anesthesiaEpidural catheter

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain levels during movement (cough)

    Patient self-assessed postoperative pain levels during movement (cough) using an unmarked zero to one hundred mm visual analog scale (VAS)

    At nine hours after the end of surgery (closure time)

Secondary Outcomes (10)

  • Postoperative pain levels during rest

    At nine hours after the end of surgery (closure time)

  • Postoperative pain levels during rest and movement

    At zero (injection), one, two, six, nine, twenty four, fourty eight hours after the end of surgery (closure time)

  • Change of type of anesthesia when regional anesthesia fails

    During the operation

  • Level of anesthesia during the operation

    During the operation

  • Incidence of hypotensions during the operation

    During the operation

  • +5 more secondary outcomes

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Spinal anesthesia + intrathecal opioid bolus (SPA)

Procedure: SPA

Group 2

ACTIVE COMPARATOR

CSE + epidural opioid bolus (CSE)

Procedure: CSE

Group 3

EXPERIMENTAL

CSE + continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs (CSEPCEA)

Procedure: CSEPCEA

Interventions

SPAPROCEDURE

Spinal anesthesia and opioids

Group 1
CSEPROCEDURE

CSE and epidural opioids

Group 2
CSEPCEAPROCEDURE

CSE and continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs

Group 3

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients aged greater than or equal to 18 years
  • Patients without severe illnesses (American Society of Anaesthesiologists \[ASA\] grade II-III)
  • Patients for elective cesarean sections
  • Informing patients about risks and complications of anesthesia until 24 hrs before operation

You may not qualify if:

  • Lacking willingness to regional procedures
  • No offered patient information and written informed consent
  • Persons without the capacity to consent
  • Unability of German language use
  • Preterm delivery \< 28 weeks of pregnancy
  • Chronic pain or chronic analgesic intake in medical history
  • Alcohol, dope and medication abuse
  • Psychiatric disease in medical history
  • Baby death after delivery
  • Anxiolytic medication
  • Allergy to local anaesthetics
  • History of bleeding tendency
  • Eclampsia and HELLP syndrome
  • Elective section out work routine time
  • Participation in another clinical trial during the trial, one month before screening and three months after screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Campus Charité Mitte, Charite University, Berlin

Berlin, State of Berlin, 13353, Germany

Location

Study Officials

  • Christian von Heymann, MD Prof.

    Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Christian von Heymann, Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charite University, Berlin, Germany.

Study Record Dates

First Submitted

November 3, 2010

First Posted

November 4, 2010

Study Start

November 1, 2010

Primary Completion

April 1, 2012

Study Completion

December 1, 2012

Last Updated

June 1, 2012

Record last verified: 2012-05

Locations

DE(1)