Influence of Surgical Regional Anesthesia on Postoperative Pain

Not Applicable

• Conditions: Elective Cesarean Section
• Interventions: Procedure: SPA; Procedure: CSE; Procedure: CSEPCEA

• Registration Number: NCT01234662
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2010-11-03
• Study First Posted: 2010-11-04
• Primary Completion: 2012-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-01
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 171

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	SPA	Spinal anesthesia + intrathecal opioid bolus (SPA)
Group 2	CSE	CSE + epidural opioid bolus (CSE)
Group 3	CSEPCEA	CSE + continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs (CSEPCEA)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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
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	Co-analgesic consumption

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Campus Charité Mitte, Charite University, Berlin; 🇩🇪 Berlin, Germany