Clinical trial NCT01234662: Influence of Surgical Regional Anesthesia on Postoperative Pain
Official title: Combined Spinal Epidural Anesthesia (CSE) vs Spinal Anesthesia for Elective Cesarean Sections. Influence of Surgical Regional Anesthesia on Postoperative Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elective Cesarean Section
Keywords: Elective cesarean sections
Postoperative pain level
Spinal anesthesia
Combined spinal epidural anesthesia
Epidural catheter
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-11-04
Enrollment: 171
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Postoperative pain levels during movement (cough)
timeFrame: At nine hours after the end of surgery (closure time)
Secondary outcomes:
measure: Postoperative pain levels during rest
timeFrame: At nine hours after the end of surgery (closure time)
measure: Postoperative pain levels during rest and movement
timeFrame: At zero (injection), one, two, six, nine, twenty four, fourty eight hours after the end of surgery (closure time)
measure: Change of type of anesthesia when regional anesthesia fails
timeFrame: During the operation
measure: Level of anesthesia during the operation
timeFrame: During the operation
measure: Incidence of hypotensions during the operation
timeFrame: During the operation
measure: Sedation level (Ramsay-Score)
timeFrame: Postoperative course
measure: Capability for mobilisation and time to first mobilisation
timeFrame: Postoperative course
measure: Incidence of adverse reactions (PONV, headache and backpain, urinary retention)
timeFrame: Postoperative course
measure: Satisfaction with pain management
timeFrame: Postoperative course
measure: Co-analgesics
timeFrame: In the 48-hour postoperative sample period
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Campus Charité Mitte, Charite University, Berlin
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum
name: Christian von Heymann, MD Prof.
role: STUDY_DIRECTOR
References: