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Influence of Surgical Regional Anesthesia on Postoperative Pain (CESAR)

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ClinicalTrials.gov Identifier: NCT01234662
Recruitment Status : Unknown
Verified May 2012 by Christian von Heymann, M.D., Charite University, Berlin, Germany.
Recruitment status was:  Active, not recruiting
First Posted : November 4, 2010
Last Update Posted : June 1, 2012
Sponsor:
Information provided by (Responsible Party):
Christian von Heymann, M.D., Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Elective Cesarean Section Procedure: SPA Procedure: CSE Procedure: CSEPCEA Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Spinal Epidural Anesthesia (CSE) vs Spinal Anesthesia for Elective Cesarean Sections. Influence of Surgical Regional Anesthesia on Postoperative Pain
Study Start Date : November 2010
Actual Primary Completion Date : April 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. Change of type of anesthesia when regional anesthesia fails [ Time Frame: During the operation ]
  4. Level of anesthesia during the operation [ Time Frame: During the operation ]
  5. Incidence of hypotensions during the operation [ Time Frame: During the operation ]
  6. Sedation level (Ramsay-Score) [ Time Frame: Postoperative course ]
  7. Capability for mobilisation and time to first mobilisation [ Time Frame: Postoperative course ]
  8. Incidence of adverse reactions (PONV, headache and backpain, urinary retention) [ Time Frame: Postoperative course ]
  9. Satisfaction with pain management [ Time Frame: Postoperative course ]
  10. Co-analgesics [ Time Frame: In the 48-hour postoperative sample period ]
    Co-analgesic consumption



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234662


Locations
Germany
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Campus Charité Mitte, Charite University, Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Director: Christian von Heymann, MD Prof. Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum

Responsible Party: Christian von Heymann, M.D., Prof. Dr. med. Christian von Heymann, Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charite University, Berlin, Germany., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01234662     History of Changes
Other Study ID Numbers: CESAR
First Posted: November 4, 2010    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: May 2012

Keywords provided by Christian von Heymann, M.D., Charite University, Berlin, Germany:
Elective cesarean sections
Postoperative pain level
Spinal anesthesia
Combined spinal epidural anesthesia
Epidural catheter

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Anesthetics
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents