Postoperative PainPhase 4TOPBLOCNCT02173418
The Effect of Phrenic Nerve Blockade on Acute and Chronic Shoulder Pain in Patients for Lobectomy and Pneumonectomy
A Phase 4 study testing Phrenic nerve block with Ropivacaine and Phrenic nerve block with saline in people with Postoperative Pain, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study was to test whether peroperative infiltration of the phrenic nerve during lung surgery would protect patients against postoperative shoulder pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Phrenic nerve block with Ropivacaine and Phrenic nerve block with saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2012to Jul 2014
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients planned for elective lobectomy or pneumonectomy
- 18 years or more on the day of the operation
- Danish skills appropriate for fulfilling preoperative questionnaires
Who cannot join
- Known contralateral paresis of the Phrenic nerve
- Allergy to Ropivacaine or Sodium Chloride
- Preoperative ipsilateral shoulder pain
- Infection or eczema on the intervention site. Clinical decision
- Dementia or similar cerebral condition that makes the subject unable to perform a NRS-score of pain. Determined by clinical evaluation
- Pregnancy
- Acute porphyria
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Departement of Anaesthesia and intensive care, Odense University Hospital
Odense, Region Syddanmark, 5000
About this study
Official title: The Effect of Phrenic Nerve Blockade on Acute and Chronic Shoulder Pain in Patients for Lobectomy and Pneumonectomy.
The purpose of this study was to test whether peroperative infiltration of the phrenic nerve during lung surgery would protect patients against postoperative shoulder pain.
- Conditions
- Postoperative Pain
- Being tested
- Phrenic nerve block with Ropivacaine, Phrenic nerve block with saline
- Keywords
- Postoperative pain, Acute postoperative pain, Chronic postoperative pain, Shoulder pain, Thoracotomy, Thoracoscopy
- Medical subject headings
- Pain, Postoperative, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phrenic nerve block with RopivacaineDrug
Also called Naropin
Phrenic nerve block with salineDrug
Also called Sodium Chloride
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Experimental | Phrenic nerve block with Ropivacaine Receives: Drug: Phrenic nerve block with Ropivacaine |
| Placebo | Placebo comparator | Phrenic nerve block with Sodium chloride Receives: Drug: Phrenic nerve block with saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder pain within 6 hours after the operation
Shoulder pain 6 hours after the operations. Number of patients and numeric rating scale score (0-10)
Measured: Retrospective numerical rating scale, 6 hours after the operation
Secondary outcomes (10)
Number of patients with shoulder pain during the first 3 postoperative days.
Measured: Postoperative days 0-3
NRS for shoulder pain during the first 3 postoperative days.
NRS=numerical rating scale score 0-10
Measured: Postoperative days 0-3
Opioid use during the first 3 postoperative days
Morphine equivalents
Measured: Postoperative day 0-3
Time spent in the recovery room
Measured: Measured at discharge from the recovery room. Estimated to be on postoperative day 0 or 1.
Shoulder pain 3 months postoperatively
Measured: 3 months postoperatively
NRS for shoulder pain 3 months postoperatively
NRS=numerical rating scale 0-10
Measured: 3 months postoperatively
Thoracic pain 3 months postoperatively
Measured: 3 months postoperatively
NRS for thoracic pain 3 months postoperatively
NRS=numerical rating scale 0-10
Measured: 3 months postoperatively
opioid use 3 months postoperatively
Measured: 3 months postoperatively
Shoulder function 3 months postoperatively
Measured by DASH-score before the operation and after 3 months
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startNov 2012
- Primary completionJul 2014
- Study completionJul 2014
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.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark, University of Southern Denmark, Læge Fritz Karners og hustrus Foundation, Overlæge dr. med. Edgar Schnohr og hustru Gilberte Schnohrs Foundation
- Responsible party
- Principal investigator, Morten Rune Blichfeldt-Eckhardt, Odense University Hospital
- Investigators
- Morten R Blichfeldt-Eckhardt, MD, Principal investigator, Departement of anaesthesia and intensive care, Odense University Hospital, Odense, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173418
- Sponsor's protocol ID
- 2012-002844-25
- Other IDs
- S-20120129, 2012-002844-25
- Acronym
- TOPBLOC
- Status last verified
- Aug 2016
- First submitted
- 18 Jun 2014
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Phrenic Nerve Blockade on Acute and Chronic Shoulder Pain in Patients for Lobectomy and Pneumonectomy.
- ClinicalTrials.gov ID
- NCT02173418
- Acronym / sponsor ID
- TOPBLOC / 2012-002844-25
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, Acute postoperative pain, Chronic postoperative pain, Shoulder pain, Thoracotomy, Thoracoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Region of Southern Denmark, University of Southern Denmark, Læge Fritz Karners og hustrus Foundation, Overlæge dr. med. Edgar Schnohr og hustru Gilberte Schnohrs Foundation
- Study start
- Nov 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Jun 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.
The purpose of this study was to test whether peroperative infiltration of the phrenic nerve during lung surgery would protect patients against postoperative shoulder pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Experimental | Drug: Phrenic nerve block with RopivacainePhrenic nerve block with Ropivacaine |
| Placebo | Placebo comparator | Drug: Phrenic nerve block with salinePhrenic nerve block with Sodium chloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients planned for elective lobectomy or pneumonectomy
- 18 years or more on the day of the operation
- Danish skills appropriate for fulfilling preoperative questionnaires
Key exclusion criteria (7 listed)
- Known contralateral paresis of the Phrenic nerve
- Allergy to Ropivacaine or Sodium Chloride
- Preoperative ipsilateral shoulder pain
- Infection or eczema on the intervention site. Clinical decision
- Dementia or similar cerebral condition that makes the subject unable to perform a NRS-score of pain. Determined by clinical evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phrenic nerve block with RopivacaineAlso: Naropin | Drug | Ropivacaine |
| Phrenic nerve block with salineAlso: Sodium Chloride | Drug | Placebo |
Primary outcome
Shoulder pain within 6 hours after the operation
Time frame: Retrospective numerical rating scale, 6 hours after the operation
Shoulder pain 6 hours after the operations. Number of patients and numeric rating scale score (0-10)
10 secondary outcomes
Number of patients with shoulder pain during the first 3 postoperative days.
Time frame: Postoperative days 0-3
NRS for shoulder pain during the first 3 postoperative days.
Time frame: Postoperative days 0-3
Opioid use during the first 3 postoperative days
Time frame: Postoperative day 0-3
Time spent in the recovery room
Time frame: Measured at discharge from the recovery room. Estimated to be on postoperative day 0 or 1.
Shoulder pain 3 months postoperatively
Time frame: 3 months postoperatively
NRS for shoulder pain 3 months postoperatively
Time frame: 3 months postoperatively
Thoracic pain 3 months postoperatively
Time frame: 3 months postoperatively
NRS for thoracic pain 3 months postoperatively
Time frame: 3 months postoperatively
opioid use 3 months postoperatively
Time frame: 3 months postoperatively
Shoulder function 3 months postoperatively
Time frame: 3 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
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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.
Morten R Blichfeldt-Eckhardt, MD principal investigator
Departement of anaesthesia and intensive care, Odense University Hospital, Odense, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phrenic nerve block with Ropivacaine and Phrenic nerve block with saline in people with Postoperative Pain, run by Odense University Hospital at 1 site in Denmark.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 17 Aug 2016. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder pain within 6 hours after the operation (time frame: Retrospective numerical rating scale, 6 hours after the operation). 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 17 Aug 2016.