Influence of Surgical Regional Anesthesia on Postoperative Pain (CESAR)

May 31, 2012 updated by: Christian von Heymann, M.D., Charite University, Berlin, Germany

Combined Spinal Epidural Anesthesia (CSE) vs Spinal Anesthesia for Elective Cesarean Sections. Influence of Surgical Regional Anesthesia on Postoperative Pain

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

171

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Campus Charité Mitte, Charite University, Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Spinal anesthesia + intrathecal opioid bolus (SPA)
Procedure: SPA
Spinal anesthesia and opioids
Active Comparator: Group 2
CSE + epidural opioid bolus (CSE)
Procedure: CSE
CSE and epidural opioids
Experimental: Group 3
CSE + continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs (CSEPCEA)
Procedure: CSEPCEA
CSE and continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain levels during movement (cough)
Time Frame: At nine hours after the end of surgery (closure time)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain levels during rest
Time Frame: At nine hours after the end of surgery (closure time)
Patient self-assessed postoperative pain levels during rest using an unmarked zero to one hundred mm visual analog scale (VAS)
At nine hours after the end of surgery (closure time)
Postoperative pain levels during rest and movement
Time Frame: At zero (injection), one, two, six, nine, twenty four, fourty eight hours after the end of surgery (closure time)
Patient self-assessed postoperative pain levels during rest and movement using an unmarked zero to one hundred mm visual analog scale (VAS)
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
Time Frame: During the operation
During the operation
Level of anesthesia during the operation
Time Frame: During the operation
During the operation
Incidence of hypotensions during the operation
Time Frame: During the operation
During the operation
Sedation level (Ramsay-Score)
Time Frame: Postoperative course
Postoperative course
Capability for mobilisation and time to first mobilisation
Time Frame: Postoperative course
Postoperative course
Incidence of adverse reactions (PONV, headache and backpain, urinary retention)
Time Frame: Postoperative course
Postoperative course
Satisfaction with pain management
Time Frame: Postoperative course
Postoperative course
Co-analgesics
Time Frame: In the 48-hour postoperative sample period
Co-analgesic consumption
In the 48-hour postoperative sample period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Study Director: Christian von Heymann, MD Prof., Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

November 3, 2010

First Posted (Estimate)

November 4, 2010

Study Record Updates

Last Update Posted (Estimate)

June 1, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CESAR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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