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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Spinal anesthesia + intrathecal opioid bolus (SPA) |
|
| Group 2 | Active Comparator | CSE + epidural opioid bolus (CSE) |
|
| Group 3 | Experimental | CSE + continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs (CSEPCEA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPA | Procedure | Spinal anesthesia and opioids |
| |
| CSE |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain levels during movement (cough) | Patient self-assessed postoperative pain levels during movement (cough) using an unmarked zero to one hundred mm visual analog scale (VAS) | At nine hours after the end of surgery (closure time) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain levels during rest | Patient self-assessed postoperative pain levels during rest using an unmarked zero to one hundred mm visual analog scale (VAS) | At nine hours after the end of surgery (closure time) |
| Postoperative pain levels during rest and movement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian von Heymann, MD Prof. | Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Campus Charité Mitte, Charite University, Berlin | Berlin | State of Berlin | 13353 | Germany |
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| Procedure |
CSE and epidural opioids |
|
| CSEPCEA | Procedure | CSE and continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs |
|
Patient self-assessed postoperative pain levels during rest and movement using an unmarked zero to one hundred mm visual analog scale (VAS) |
| At zero (injection), one, two, six, nine, twenty four, fourty eight hours after the end of surgery (closure time) |
| Change of type of anesthesia when regional anesthesia fails | During the operation |
| Level of anesthesia during the operation | During the operation |
| Incidence of hypotensions during the operation | During the operation |
| Sedation level (Ramsay-Score) | Postoperative course |
| Capability for mobilisation and time to first mobilisation | Postoperative course |
| Incidence of adverse reactions (PONV, headache and backpain, urinary retention) | Postoperative course |
| Satisfaction with pain management | Postoperative course |
| Co-analgesics | Co-analgesic consumption | In the 48-hour postoperative sample period |