Influence of Surgical Regional Anesthesia on Postoperative Pain

Elective Cesarean Section Clinical Trial

— CESAR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01234662
• Other study ID #: CESAR
• Status: Active, not recruiting
• Phase: N/A
• First received: November 3, 2010
• Last updated: May 31, 2012
• Start date: November 2010
• Est. completion date: December 2012

Study information

• Verified date: May 2012
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 171
• Est. completion date: December 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elective Cesarean Section
• Pain, Postoperative

Intervention

Procedure:
• SPA
Spinal anesthesia and opioids
• CSE
CSE and epidural opioids
• CSEPCEA
CSE and continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Campus Charité Mitte, Charite University, Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	Change of type of anesthesia when regional anesthesia fails		During the operation	Yes
Secondary	Level of anesthesia during the operation		During the operation	Yes
Secondary	Incidence of hypotensions during the operation		During the operation	Yes
Secondary	Sedation level (Ramsay-Score)		Postoperative course	Yes
Secondary	Capability for mobilisation and time to first mobilisation		Postoperative course	Yes
Secondary	Incidence of adverse reactions (PONV, headache and backpain, urinary retention)		Postoperative course	Yes
Secondary	Satisfaction with pain management		Postoperative course	No
Secondary	Co-analgesics	Co-analgesic consumption	In the 48-hour postoperative sample period	Yes