Influence of Surgical Regional Anesthesia on Postoperative Pain (CESAR)

Charité University Medicine Berlin

Status: Unknown

Conditions: Elective Cesarean Section

Treatments: Procedure: CSEPCEA; Procedure: CSE; Procedure: SPA

Study type: Interventional

Funder types: Other

Identifiers

NCT01234662

CESAR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 171 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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171 participants in 3 patient groups

Group 1

Active Comparator group

Description:

Spinal anesthesia + intrathecal opioid bolus (SPA)

Treatment:

Procedure: SPA

Group 2

Active Comparator group

Description:

CSE + epidural opioid bolus (CSE)

Treatment:

Procedure: CSE

Group 3

Experimental group

Description:

CSE + continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs (CSEPCEA)

Treatment:

Procedure: CSEPCEA