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OpenTrials
Completed

NCT Number: NCT01076894

Thoracotomy: Intercostal Nerve Block Versus Epidural Anesthesia

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

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Key information

Conditions

Thoracotomy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universtity Clinic Ulm

Ulm, 89075, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Pain at rest and on coughing after thoracic surgery

    Time frame: Pain during the first four postoperative days

Secondary outcomes

  1. pulmonary function (peak expiratory flow rate) after thoracic surgery

    Time frame: first four postoperative days

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Feb 26, 2010
Registry last updated
Feb 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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