Elective Cesarean Section
Conditions
Keywords
Elective cesarean sections, Postoperative pain level, Spinal anesthesia, Combined spinal epidural anesthesia, Epidural catheter
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.
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.
Interventions
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain levels during movement (cough) | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain levels during rest and movement | 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) |
| 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 | — |
| Postoperative pain levels during rest | 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) |
| 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 | In the 48-hour postoperative sample period | Co-analgesic consumption |
| Sedation level (Ramsay-Score) | Postoperative course | — |
Countries
Germany
Outcome results
None listed