Influence of Surgical Regional Anesthesia on Postoperative Pain

NCT ID: NCT01234662

Last Updated: 2012-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-12-31

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.

Conditions

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Elective Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Spinal anesthesia + intrathecal opioid bolus (SPA)

Group Type ACTIVE_COMPARATOR

SPA

Intervention Type PROCEDURE

Spinal anesthesia and opioids

Group 2

CSE + epidural opioid bolus (CSE)

Group Type ACTIVE_COMPARATOR

CSE

Intervention Type PROCEDURE

CSE and epidural opioids

Group 3

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

Group Type EXPERIMENTAL

CSEPCEA

Intervention Type PROCEDURE

CSE and continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs

Interventions

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SPA

Spinal anesthesia and opioids

Intervention Type PROCEDURE

CSE

CSE and epidural opioids

Intervention Type PROCEDURE

CSEPCEA

CSE and continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Christian von Heymann, M.D.

Prof. Dr. med. Christian von Heymann, Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charite University, Berlin, Germany.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian von Heymann, MD Prof.

Role: STUDY_DIRECTOR

Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum

Locations

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

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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CESAR

Identifier Type: -

Identifier Source: org_study_id

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