Influence of Surgical Regional Anesthesia on Postoperative Pain (CESAR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Charite University, Berlin, Germany.
Recruitment status was  Active, not recruiting
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
  Purpose

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 Intervention
Elective Cesarean Section
Procedure: SPA
Procedure: CSE
Procedure: CSEPCEA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 171
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: November 3, 2010
Last Updated: May 31, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Elective cesarean sections
Postoperative pain level
Spinal anesthesia
Combined spinal epidural anesthesia
Epidural catheter

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014