Thoracotomy: Intercostal Nerve Block Versus Epidural Anesthesia

Thoracotomy Clinical Trial

Official title:

Analgesia and Pulmonary Function After Thoracic Surgery: is an Intercostal Nerve Block Plus Intravenous Morphine as Effective as Epidural Anesthesia? A Prospective Randomized Clinical Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076894
• Other study ID #: EDA-ICB 198/06
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: February 25, 2010
• Start date: February 2007
• Est. completion date: October 2009

Study information

• Verified date: February 2010
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethics Commission: Germany
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: October 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Thoracotomy

Intervention

Procedure:
• 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.
• 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

Locations

Country	Name	City	State
Germany	Universtity Clinic Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain at rest and on coughing after thoracic surgery		Pain during the first four postoperative days	No
Secondary	pulmonary function (peak expiratory flow rate) after thoracic surgery		first four postoperative days	No