Postoperative PainRATSNCT02305719
Regional Anesthesia for Thoracoscopic Surgery
An observational study of Postoperative Pain, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Aim of the study is to evaluate different regional anesthesia regimes for thoracoscopic surgery to evaluate their efficiency in (postoperative) pain control. Three regional anesthesia forms are evaluated: thoracic epidural anesthesia, (ultrasound-guided) serratus-anterior-plane-block an local infiltration with local… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2014to Jun 2016
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for thoracoscopic surgery ASA 1-3
Who may be able to join
- Patients scheduled for thoracoscopic surgery
- ASA 1-3
Who cannot join
- ASA 4 and 5
- Age under 18 and over 80
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Munich, Marchioninistr. 15
Munich, 81377
Philip M Lang, M.D., Ph.D., ++49-89-4400 ext. 73429, philip.lang@med.uni-muenchen.de
Philipp Hering, M.D., ++49-89-4400 ext. 73410, philipp.hering@med.uni-muenchen.de
About this study
Aim of the study is to evaluate different regional anesthesia regimes for thoracoscopic surgery to evaluate their efficiency in (postoperative) pain control.
Three regional anesthesia forms are evaluated: thoracic epidural anesthesia, (ultrasound-guided) serratus-anterior-plane-block an local infiltration with local anesthetic at the site of performing the thoracoscopy.
Read the detailed description
A prospective evaluation of different regional anesthesia regimes for thoracoscopic surgery to elucidate their efficiency in (postoperative) pain control.
A day before surgery the patients gave their written informed consent to the study.
Patients choose their favorite regional anesthesia out of the following: thoracic epidural anesthesia, (ultrasound-guided) serratus-anterior-plane-block an local infiltration with local anesthetic at the site of performing the thoracoscopy.
In addition a general anesthesia was applied for the surgical procedure. Anesthesia was maintained using propofol and remifentanil. The patients pain score (visual analog scale), consumption of analgesic medication, satisfaction with pain therapy will be obtained one, six, 24 and 48 hours postoperatively.
These prospective evaluation of different regional anesthetic techniques might provide us data to recommend a procedure for thoracoscopic surgery.
- Conditions
- Postoperative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Epidural anesthesia | Patients receiving thoracic epidural anesthesia for thoracoscopic surgery. Standard regimen with 8-20 ml Ropivacaine 0,5% in the epidural catheter. Postopertive Ropivacaine 0,2% 6 ml/h via catheter were administered. | |
| Serratus-anterior-plane-Block | Patients receiving (ultrasound-guided) Serratus-anterior-plane-Block for thoracoscopic surgery. Standard regimen up to 20 ml Ropivacaine 0,5%, were installed. Postopertive Ropivacaine 0,2% 6 ml/h via catheter were administered. | |
| Local infiltration | Patients receiving local infiltration with up to 20 ml Ropivacaine 0,5% for thoracoscopic surgery (at the site of thoracoscopy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain (visual analog scale)
the postoperative Pain, evaluated with a visual analog scale (VAS), was obtained in the first 48 hours postoperatively after thoracoscopic surgery
Measured: 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Lang, Ludwig-Maximilians - University of Munich
- Investigators
- Philip M Lang, M.D., Ph. D., Principal investigator, Attending
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305719
- Sponsor's protocol ID
- LudwigMaximilians
- Acronym
- RATS
- Status last verified
- Nov 2014
- First submitted
- 28 Nov 2014
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Anesthesia for Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT02305719
- Acronym / sponsor ID
- RATS / LudwigMaximilians
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study is to evaluate different regional anesthesia regimes for thoracoscopic surgery to evaluate their efficiency in (postoperative) pain control.
Three regional anesthesia forms are evaluated: thoracic epidural anesthesia, (ultrasound-guided) serratus-anterior-plane-block an local infiltration with local anesthetic at the site of performing the thoracoscopy.
Detailed description
A prospective evaluation of different regional anesthesia regimes for thoracoscopic surgery to elucidate their efficiency in (postoperative) pain control.
A day before surgery the patients gave their written informed consent to the study.
Patients choose their favorite regional anesthesia out of the following: thoracic epidural anesthesia, (ultrasound-guided) serratus-anterior-plane-block an local infiltration with local anesthetic at the site of performing the thoracoscopy.
In addition a general anesthesia was applied for the surgical procedure. Anesthesia was maintained using propofol and remifentanil. The patients pain score (visual analog scale), consumption of analgesic medication, satisfaction with pain therapy will be obtained one, six, 24 and 48 hours postoperatively.
These prospective evaluation of different regional anesthetic techniques might provide us data to recommend a procedure for thoracoscopic surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epidural anesthesia | – | –Patients receiving thoracic epidural anesthesia for thoracoscopic surgery. Standard regimen with 8-20 ml Ropivacaine 0,5% in the epidural catheter. Postopertive Ropivacaine 0,2% 6 ml/h via catheter were administered. |
| Serratus-anterior-plane-Block | – | –Patients receiving (ultrasound-guided) Serratus-anterior-plane-Block for thoracoscopic surgery. Standard regimen up to 20 ml Ropivacaine 0,5%, were installed. Postopertive Ropivacaine 0,2% 6 ml/h via catheter were administered. |
| Local infiltration | – | –Patients receiving local infiltration with up to 20 ml Ropivacaine 0,5% for thoracoscopic surgery (at the site of thoracoscopy) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for thoracoscopic surgery ASA 1-3
Key inclusion criteria (2 listed)
- Patients scheduled for thoracoscopic surgery
- ASA 1-3
Key exclusion criteria (2 listed)
- ASA 4 and 5
- Age under 18 and over 80
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Pain (visual analog scale)
Time frame: 48 hours postoperative
the postoperative Pain, evaluated with a visual analog scale (VAS), was obtained in the first 48 hours postoperatively after thoracoscopic surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip M Lang, M.D., Ph. D. principal investigator
Attending
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip M Lang, M.D., Ph.D. (++49-89-4400 ext. 73429, philip.lang@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (visual analog scale) (time frame: 48 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.