Combined Spinal Epidural Anesthesia (CSE) vs Spinal Anesthesia for Elective Cesarean Sections. Influence of Surgical Regional Anesthesia on Postoperative Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Elective Cesarean Section
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 171
- Locations
- 1
- Primary Endpoint
- Postoperative pain levels during movement (cough)
- Last Updated
- 13 years ago
Overview
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.
Investigators
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
Eligibility 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
Outcomes
Primary Outcomes
Postoperative pain levels during movement (cough)
Time Frame: 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 Outcomes
- Postoperative pain levels during rest(At nine hours after the end of surgery (closure time))
- 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))
- 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(In the 48-hour postoperative sample period)