Influence of Surgical Regional Anesthesia on Postoperative Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Combined Spinal Epidural Anesthesia (CSE) vs Spinal Anesthesia for Elective Cesarean Sections. Influence of Surgical Regional Anesthesia on Postoperative Pain

Conditions
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Elective Cesarean Section

Intervention / Treatment
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* Procedure: SPA
* Procedure: CSE
* Procedure: CSEPCEA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Spinal anesthesia + intrathecal opioid bolus (SPA) | Procedure: SPA<br>* Spinal anesthesia and opioids<br>|
| Active Comparator: Group 2<br>CSE + epidural opioid bolus (CSE) | Procedure: CSE<br>* CSE and epidural opioids<br>|
| Experimental: Group 3<br>CSE + continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs (CSEPCEA) | Procedure: CSEPCEA<br>* CSE and continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elective cesarean sections, Postoperative pain level, Spinal anesthesia, Combined spinal epidural anesthesia, Epidural catheter