Influence of Surgical Regional Anesthesia on Postoperative Pain (CESAR)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Christian von Heymann, M.D., Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT01234662

First received: November 3, 2010

Last updated: May 31, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 3, 2010

Last Updated Date

May 31, 2012

Start Date ^ICMJE

November 2010

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Postoperative pain levels during movement (cough) [ Time Frame: At nine hours after the end of surgery (closure time) ] [ Designated as safety issue: Yes ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01234662 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Postoperative pain levels during rest [ Time Frame: At nine hours after the end of surgery (closure time) ] [ Designated as safety issue: Yes ]
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 [ Time Frame: At zero (injection), one, two, six, nine, twenty four, fourty eight hours after the end of surgery (closure time) ] [ Designated as safety issue: Yes ]
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 [ Time Frame: During the operation ] [ Designated as safety issue: Yes ]
Level of anesthesia during the operation [ Time Frame: During the operation ] [ Designated as safety issue: Yes ]
Incidence of hypotensions during the operation [ Time Frame: During the operation ] [ Designated as safety issue: Yes ]
Sedation level (Ramsay-Score) [ Time Frame: Postoperative course ] [ Designated as safety issue: Yes ]
Capability for mobilisation and time to first mobilisation [ Time Frame: Postoperative course ] [ Designated as safety issue: Yes ]
Incidence of adverse reactions (PONV, headache and backpain, urinary retention) [ Time Frame: Postoperative course ] [ Designated as safety issue: Yes ]
Satisfaction with pain management [ Time Frame: Postoperative course ] [ Designated as safety issue: No ]
Co-analgesics [ Time Frame: In the 48-hour postoperative sample period ] [ Designated as safety issue: Yes ]
Co-analgesic consumption

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Influence of Surgical Regional Anesthesia on Postoperative Pain

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Elective Cesarean Section

Intervention ^ICMJE

Procedure: SPA
Spinal anesthesia and opioids
Procedure: CSE
CSE and epidural opioids
Procedure: CSEPCEA
CSE and continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs

Study Arm (s)

Active Comparator: Group 1
Spinal anesthesia + intrathecal opioid bolus (SPA)

Intervention: Procedure: SPA
Active Comparator: Group 2
CSE + epidural opioid bolus (CSE)

Intervention: Procedure: CSE
Experimental: Group 3
CSE + continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs (CSEPCEA)

Intervention: Procedure: CSEPCEA

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

171

Estimated Completion Date

December 2012

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01234662

Other Study ID Numbers ^ICMJE

CESAR

Has Data Monitoring Committee

Responsible Party

Christian von Heymann, M.D., Charite University, Berlin, Germany

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Christian von Heymann, MD Prof.

Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum

Information Provided By

Charite University, Berlin, Germany

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top