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Influence of Surgical Regional Anesthesia on Postoperative Pain (CESAR)

Primary Purpose

Elective Cesarean Section

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
SPA
CSE
CSEPCEA
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elective Cesarean Section focused on measuring Elective cesarean sections, Postoperative pain level, Spinal anesthesia, Combined spinal epidural anesthesia, Epidural catheter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

Spinal anesthesia + intrathecal opioid bolus (SPA)

CSE + epidural opioid bolus (CSE)

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Postoperative pain levels during rest
Patient self-assessed postoperative pain levels during rest using an unmarked zero to one hundred mm visual analog scale (VAS)
Postoperative pain levels during rest and movement
Patient self-assessed postoperative pain levels during rest and movement using an unmarked zero to one hundred mm visual analog scale (VAS)
Change of type of anesthesia when regional anesthesia fails
Level of anesthesia during the operation
Incidence of hypotensions during the operation
Sedation level (Ramsay-Score)
Capability for mobilisation and time to first mobilisation
Incidence of adverse reactions (PONV, headache and backpain, urinary retention)
Satisfaction with pain management
Co-analgesics
Co-analgesic consumption

Full Information

First Posted
November 3, 2010
Last Updated
May 31, 2012
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01234662
Brief Title
Influence of Surgical Regional Anesthesia on Postoperative Pain
Acronym
CESAR
Official Title
Combined Spinal Epidural Anesthesia (CSE) vs Spinal Anesthesia for Elective Cesarean Sections. Influence of Surgical Regional Anesthesia on Postoperative Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Regional analgesia is the most effective way of providing analgesia during labor and delivery. By using a combination of local anesthetics and opioids, it is often possible to avoid motor block. Spinal anesthesia is suitable for most elective cesarean sections. Epidural anesthesia and in particular catheter based epidural anesthesia allow a gradual extension of anesthesia and are suitable for prolonged treatment of postoperative pain. It is unclear which anesthetic technique provides better pain relief after cesarean section. This prospective, randomized study compares the effectiveness of three types of regional anesthetic techniques (Spinal anesthesia, Combined spinal epidural anesthesia, Combined spinal epidural anesthesia with indwelling catheter for 24 hrs) on pain after elective cesarean section.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elective Cesarean Section
Keywords
Elective cesarean sections, Postoperative pain level, Spinal anesthesia, Combined spinal epidural anesthesia, Epidural catheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
171 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Spinal anesthesia + intrathecal opioid bolus (SPA)
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
CSE + epidural opioid bolus (CSE)
Arm Title
Group 3
Arm Type
Experimental
Arm Description
CSE + continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs (CSEPCEA)
Intervention Type
Procedure
Intervention Name(s)
SPA
Intervention Description
Spinal anesthesia and opioids
Intervention Type
Procedure
Intervention Name(s)
CSE
Intervention Description
CSE and epidural opioids
Intervention Type
Procedure
Intervention Name(s)
CSEPCEA
Intervention Description
CSE and continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs
Primary Outcome Measure Information:
Title
Postoperative pain levels during movement (cough)
Description
Patient self-assessed postoperative pain levels during movement (cough) using an unmarked zero to one hundred mm visual analog scale (VAS)
Time Frame
At nine hours after the end of surgery (closure time)
Secondary Outcome Measure Information:
Title
Postoperative pain levels during rest
Description
Patient self-assessed postoperative pain levels during rest using an unmarked zero to one hundred mm visual analog scale (VAS)
Time Frame
At nine hours after the end of surgery (closure time)
Title
Postoperative pain levels during rest and movement
Description
Patient self-assessed postoperative pain levels during rest and movement using an unmarked zero to one hundred mm visual analog scale (VAS)
Time Frame
At zero (injection), one, two, six, nine, twenty four, fourty eight hours after the end of surgery (closure time)
Title
Change of type of anesthesia when regional anesthesia fails
Time Frame
During the operation
Title
Level of anesthesia during the operation
Time Frame
During the operation
Title
Incidence of hypotensions during the operation
Time Frame
During the operation
Title
Sedation level (Ramsay-Score)
Time Frame
Postoperative course
Title
Capability for mobilisation and time to first mobilisation
Time Frame
Postoperative course
Title
Incidence of adverse reactions (PONV, headache and backpain, urinary retention)
Time Frame
Postoperative course
Title
Satisfaction with pain management
Time Frame
Postoperative course
Title
Co-analgesics
Description
Co-analgesic consumption
Time Frame
In the 48-hour postoperative sample period

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian von Heymann, MD Prof.
Organizational Affiliation
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Campus Charité Mitte, Charite University, Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany

12. IPD Sharing Statement

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Influence of Surgical Regional Anesthesia on Postoperative Pain

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