Thoracotomy: Intercostal Nerve Block Versus Epidural Anesthesia

NCT01076894 | Completed

• 1 other identifier: EDA-ICB 198/06
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thoracotomy

Keywords

pain; thoracotomy; pulmonary function; epidural anesthesia; intercostal nerve block

Outcome Measures

Primary Outcomes (1)

• Pain at rest and on coughing after thoracic surgery

  Pain during the first four postoperative days

Secondary Outcomes (1)

• pulmonary function (peak expiratory flow rate) after thoracic surgery

  first four postoperative days

Study Arms (2)

epidural anesthesia

ACTIVE COMPARATOR

Procedure: epidural anesthesia

intercostal anesthesia

ACTIVE COMPARATOR

Procedure: intercostal anesthesia

Interventions

epidural anesthesia 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.

epidural anesthesia

intercostal anesthesia 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

intercostal anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

Universtity Clinic Ulm

Ulm, 89075, Germany

Location

MeSH Terms

Conditions

Pain

Interventions

Anesthesia, Epidural

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Michael Georgieff, Prof.

  Department for Anesthesiology University Clinic Ulm

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: February 26, 2010
• Study Start: February 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2009
• Last Updated: February 26, 2010

Record last verified: 2010-02

Locations

DE (1)