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

November 3, 2010
May 31, 2012
November 2010
April 2012   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01234662 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Influence of Surgical Regional Anesthesia on Postoperative Pain
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Elective Cesarean Section
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
171
December 2012
April 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01234662
CESAR
No
Christian von Heymann, M.D., Charite University, Berlin, Germany
Charite University, Berlin, Germany
Not Provided
Study Director: Christian von Heymann, MD Prof. Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum
Charite University, Berlin, Germany
May 2012

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