Influence of Surgical Regional Anesthesia on Postoperative Pain (CESAR)
This study is ongoing, but not recruiting participants.
Sponsor:
Charite University, Berlin, Germany
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
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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
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 May 16, 2013