Prospective, Randomised, Single-Blinded, Monocentric Clinical Study to Compare Postoperative Analgesia and Outcome After Combined Paravertebral and Intrathecal Versus Thoracic Epidural Analgesia for Thoracotomy

NCT00493909 | Completed Phase 4 DMC

• 1 other identifier: TL-2007-06
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare whether epidural analgesia would provide equal analgesia than combining intrathecal opioids with thoracic paravertebral local anesthetics.

Conditions

Pain, Postoperative

Keywords

thoracotomy; pain therapy; thoracic paravertebral blockade; intrathecal opioids; thoracic epidural analgesia; Analgesia after thoracotomy

Outcome Measures

Primary Outcomes (1)

• The primary outcome measures used are pain at rest, at coughing, and on movement at each time point, as reported by the patient using a standard Visual Analogue Score (VAS).

  within the first three days

Secondary Outcomes (1)

• incidence of side-effects (nausea, vomiting, sedation score, respiratory depression, hypotension, pruritus, urinary retention), total number of doses of piritramide administered, patient satisfaction, and incidence of chronic pain.

  within one year

Study Arms (2)

1

ACTIVE COMPARATOR

thoracic epidural analgesia

Procedure: intrathecal opioids and thoracic paravertebral analgesia; Procedure: thoracic epidural analgesia

2

ACTIVE COMPARATOR

intrathecal opioids and thoracic paravertebral analgesia

Procedure: intrathecal opioids and thoracic paravertebral analgesia

Interventions

intrathecal opioids and thoracic paravertebral analgesia PROCEDURE

1; 2

thoracic epidural analgesia PROCEDURE

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sex: male/female
• Age: 18 - 75 years
• Informed consent of the patient
• Elective thoracotomy
• Two chest drains

You may not qualify if:

• Contraindications against the use of regional techniques: known allergy to local anesthetics
• Infection around the puncture site
• Coagulation disorders
• Drug abuse
• Emergency surgery
• Pregnancy

Sponsors & Collaborators

• University Hospital Freiburg: lead

Study Sites (1)

Department of Thoracic Surgery, University Medical Center

Freiburg im Breisgau, D-79106, Germany

Location

Related Publications (1)

• Dango S, Harris S, Offner K, Hennings E, Priebe HJ, Buerkle H, Passlick B, Loop T. Combined paravertebral and intrathecal vs thoracic epidural analgesia for post-thoracotomy pain relief. Br J Anaesth. 2013 Mar;110(3):443-9. doi: 10.1093/bja/aes394. Epub 2012 Nov 14.

  PMID: 23151421 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Tea

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Torsten Loop, M.D.

  Department of Anesthesiology and Critical Care Medicine, University Medical Center, Hugstetterstrasse 55, D-79106 Freiburg, Germany,

  PRINCIPAL INVESTIGATOR

• Sebastian Dango, M.D.

  Department of Thoracic Surgery, University Medical Center, Hugstetterstrasse 55, D-79106 Freiburg, Germany,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 28, 2007
• First Posted: June 29, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 16, 2009

Record last verified: 2009-02

Locations

DE (1)