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Thoracotomy: Intercostal Nerve Block Versus Epidural Anesthesia

NCT ID: NCT01076894

Last Updated: 2010-02-26

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

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-10-31

Brief Summary

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Postoperative pain and consecutive reduction of pulmonary function after thoracic surgery still is a major clinical problem and challenge in anesthesia. Thoracic epidural anesthesia is commonly considered to be the "gold standard" for postoperative pain control and restoration of pulmonary function after thoracic surgery.

Thus, the aim of the present study is to investigate whether an intercostal nerve block with ropivacaine plus intravenous PCA with morphine is as effective as thoracic epidural anesthesia with respect to postoperative pain control and pulmonary

Detailed Description

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Conditions

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Thoracotomy

Keywords

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pain thoracotomy pulmonary function epidural anesthesia intercostal nerve block

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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epidural anesthesia

Group Type ACTIVE_COMPARATOR

epidural anesthesia

Intervention Type PROCEDURE

In the epidural group prior to the induction of general anesthesia, a thoracic epidural catheter will be was placed at the level of the TH6-TH8. 8 ml ropivacaine 1% were administered through the epidural catheter. EDA is aimed at a sensory block level from TH2 to TH10.

intercostal anesthesia

Group Type ACTIVE_COMPARATOR

intercostal anesthesia

Intervention Type PROCEDURE

In the intercostal group, before chest closure, each 4 ml ropivacaine 0.75 % will be injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and two spaces above and below as well as 5 ml ropivacaine 0,75 % at the thoracic drainage tube exits

Interventions

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epidural anesthesia

In the epidural group prior to the induction of general anesthesia, a thoracic epidural catheter will be was placed at the level of the TH6-TH8. 8 ml ropivacaine 1% were administered through the epidural catheter. EDA is aimed at a sensory block level from TH2 to TH10.

Intervention Type PROCEDURE

intercostal anesthesia

In the intercostal group, before chest closure, each 4 ml ropivacaine 0.75 % will be injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and two spaces above and below as well as 5 ml ropivacaine 0,75 % at the thoracic drainage tube exits

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients undergoing elective pulmonary surgery, including pneumonectomy, bilobectomy, lobectomy, typical and atypical segmentectomy, via a lateral or posterolateral thoracotomy without chest-wall resection

Exclusion Criteria

* age\<18 yr
* any contraindication to epidural anaesthesia, intercostal nerve block or the use of ropivacaine, morphine, metamizol or diclofenac
* lack of patient's cooperation
* any type of chronic painful condition or current opioid use
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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University Clinic Ulm

Principal Investigators

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Michael Georgieff, Prof.

Role: STUDY_CHAIR

Department for Anesthesiology University Clinic Ulm

Locations

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Universtity Clinic Ulm

Ulm, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EDA-ICB 198/06

Identifier Type: -

Identifier Source: org_study_id