Prospective, Randomised, Single-Blinded, Monocentric Clinical Study to Compare Postoperative Analgesia and Outcome After Combined Paravertebral and Intrathecal Versus Thoracic Epidural Analgesia for Thoracotomy
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
intrathecal opioids and thoracic paravertebral analgesia
thoracic epidural analgesia
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring thoracotomy, pain therapy, thoracic paravertebral blockade, intrathecal opioids, thoracic epidural analgesia, Analgesia after thoracotomy
Eligibility Criteria
Inclusion Criteria:
- Sex: male/female
- Age: 18 - 75 years
- Informed consent of the patient
- Elective thoracotomy
- Two chest drains
Exclusion Criteria:
- Contraindications against the use of regional techniques: known allergy to local anesthetics
- Infection around the puncture site
- Coagulation disorders
- Drug abuse
- Emergency surgery
- Pregnancy
Sites / Locations
- Department of Thoracic Surgery, University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
thoracic epidural analgesia
intrathecal opioids and thoracic paravertebral analgesia
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00493909
First Posted
June 28, 2007
Last Updated
February 12, 2009
Sponsor
University Hospital Freiburg
1. Study Identification
Unique Protocol Identification Number
NCT00493909
Brief Title
Prospective, Randomised, Single-Blinded, Monocentric Clinical Study to Compare Postoperative Analgesia and Outcome After Combined Paravertebral and Intrathecal Versus Thoracic Epidural Analgesia for Thoracotomy
Official Title
Prospective, Randomised, Single-Blinded, Monocentric Clinical Study to Compare Postoperative Analgesia and Outcome After Combined Paravertebral and Intrathecal Versus Thoracic Epidural Analgesia for Thoracotomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Freiburg
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Thoracotomy is an invasive surgical procedure, which is mainly performed in patients with pre-existing lung disease such as lung cancer or chronic obstructive pulmonary disease. Pain after thoracotomy is considered the most intense acute postoperative pain, adversely affecting the ability to cough, deep breathing, and lung function, resulting in respiratory complications and delayed recovery. The adverse effects can be further aggravated by occurrence of chronic post-thoracotomy pain.
Thoracic epidural analgesia is often recommended as the gold standard for the relief of acute post-thoracotomy pain. Thoracic paravertebral blockade or intrathecal opioid analgesia has also been shown to be efficacious for pain relief. Since there is no ideal single regional technique for pain relief after thoracotomy an alternative method maybe the combination of low-dose intrathecal morphine and sufentanil plus continuous thoracic paravertebral analgesia with local anesthetics.
We therefore hypothesized that combining intrathecal sufentanil and morphine with thoracic paravertebral applicated ropivacaine would provide equal analgesia compared to thoracic epidural analgesia with ropivacaine and sufentanil. We further speculate that this new regimen would have a lower incidence of typical side effects due to TEA, such as block failure, hypotension or urinary retention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
thoracotomy, pain therapy, thoracic paravertebral blockade, intrathecal opioids, thoracic epidural analgesia, Analgesia after thoracotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
thoracic epidural analgesia
Arm Title
2
Arm Type
Active Comparator
Arm Description
intrathecal opioids and thoracic paravertebral analgesia
Intervention Type
Procedure
Intervention Name(s)
intrathecal opioids and thoracic paravertebral analgesia
Intervention Type
Procedure
Intervention Name(s)
thoracic epidural analgesia
Primary Outcome Measure Information:
Title
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).
Time Frame
within the first three days
Secondary Outcome Measure Information:
Title
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.
Time Frame
within one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sex: male/female
Age: 18 - 75 years
Informed consent of the patient
Elective thoracotomy
Two chest drains
Exclusion Criteria:
Contraindications against the use of regional techniques: known allergy to local anesthetics
Infection around the puncture site
Coagulation disorders
Drug abuse
Emergency surgery
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torsten Loop, M.D.
Organizational Affiliation
Department of Anesthesiology and Critical Care Medicine, University Medical Center, Hugstetterstrasse 55, D-79106 Freiburg, Germany,
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sebastian Dango, M.D.
Organizational Affiliation
Department of Thoracic Surgery, University Medical Center, Hugstetterstrasse 55, D-79106 Freiburg, Germany,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Thoracic Surgery, University Medical Center
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
23151421
Citation
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.
Results Reference
derived
Learn more about this trial
Prospective, Randomised, Single-Blinded, Monocentric Clinical Study to Compare Postoperative Analgesia and Outcome After Combined Paravertebral and Intrathecal Versus Thoracic Epidural Analgesia for Thoracotomy
We'll reach out to this number within 24 hrs