Shoulder PainPhase 2NCT01288924
Can Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain?
A Phase 2 study testing Parecoxib in people with Shoulder Pain and Post-operative Pain, run by Chiang Mai University at 2 sites in Thailand.
Trial summary
The purpose of this study is to compare the efficacy of parecoxib with placebo on the incidence and severity of postthoracotomy shoulder pain, the amount of analgesic requirement for relieving severity of postthoracotomy shoulder pain and adverse events associated with treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Pain, Post-operative Pain
- What is being tested?
- Parecoxib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesThailand
- Study dates
- Feb 2011to Jan 2016
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiology (ASA) physical status I-III
- Undergoing pulmonary resection by open thoracotomy
Who cannot join
- Unable to understand numeric rating scale despite preoperative coaching
- Preexisting shoulder pain at the same operative side
- Having contraindication for thoracic epidural analgesia
- History of previous myocardial ischemia or cerebrovascular accident
- Allergic to NSAIDS, sulfonamides or parecoxib
- Hepatic or renal impairment
Show all 9Show fewer
- History of current gastrointestinal symptoms
- Fluid retention or congestive heart failure
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Department of Anesthesiology, Faculty of Medicine, Chiang Mai University
Maung, Chiang Mai, 50200
Department of Anesthesiology, Faculty of Medicine
Maung, Chiang Mai, 50200
About this study
Official title: Can Preemptive Analgesia With Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain? A Double-blinded, Randomized, Placebo-controlled Trial.
The purpose of this study is to compare the efficacy of parecoxib with placebo on the incidence and severity of postthoracotomy shoulder pain, the amount of analgesic requirement for relieving severity of postthoracotomy shoulder pain and adverse events associated with treatment.
Read the detailed description
The incidence of Post-operative Ipsilateral Shoulder Pain (PISP) varies from 21-97% after thoracic surgery, despite receiving effective thoracic epidural analgesia. This pain has been described as constant, aching in quality, unrelated to position change or respiration. Possible causes of shoulder pain includes injury of the phrenic nerve, the lateral decubitus position, transection of major bronchus or preexisting arthritis condition. The possibilities of prevention and management of PISP are taken into consideration. Thoracic epidural block will be performed in all patients before general anesthesia.
- Conditions
- Shoulder Pain, Post-operative Pain
- Being tested
- Parecoxib, Control
- Medical subject headings
- Shoulder Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParecoxibDrug
Also called Dynastat
Parecoxib 40 mg intravenous before surgery and every 12 hours for two days.
ControlOther
NSS 2 ml intravenous before surgery and every 12 hours for two days.
| Study group | Role | What they receive |
|---|---|---|
| Parecoxib | Active comparator | Parecoxib 2 ml intravenous Receives: Drug: Parecoxib |
| Control | Placebo comparator | 0.9% sodium chloride 2 ml intravenous Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS) of shoulder pain and incisional pain at rest and movement
Measured: at 2 ,6 ,12 ,24 ,48,72 and 96 hours after the operation
Secondary outcomes (2)
compare an amount of morphine consumption
Measured: at 2,6 ,12,24,48,72 and 96 hours after the operation
adverse effect related to parecoxib
Measured: during 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanyong Pipanmekaporn, Chiang Mai University
- Investigators
- Tanyong Pipanmekaporn, MD, Principal investigator, Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288924
- Sponsor's protocol ID
- COM-10-11-19A-12
- Other IDs
- research ID 79
- Status last verified
- Dec 2016
- First submitted
- 1 Feb 2011
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bamgbade OA, Dorje P, Adhikary GS. The dual etiology of ipsilateral shoulder pain after thoracic surgery. J Clin Anesth. 2007 Jun;19(4):296-8. doi: 10.1016/j.jclinane.2006.09.010.
PubMed 17572327MacDougall P. Postthoracotomy shoulder pain: diagnosis and management. Curr Opin Anaesthesiol. 2008 Feb;21(1):12-5. doi: 10.1097/ACO.0b013e3282f2bb67.
PubMed 18195603
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Preemptive Analgesia With Parecoxib Reduce Post-operative Ipsilateral Shoulder Pain? A Double-blinded, Randomized, Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT01288924
- Acronym / sponsor ID
- COM-10-11-19A-12
- Conditions
- Shoulder Pain, Post-operative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 3 Feb 2011 (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 is to compare the efficacy of parecoxib with placebo on the incidence and severity of postthoracotomy shoulder pain, the amount of analgesic requirement for relieving severity of postthoracotomy shoulder pain and adverse events associated with treatment.
Detailed description
The incidence of Post-operative Ipsilateral Shoulder Pain (PISP) varies from 21-97% after thoracic surgery, despite receiving effective thoracic epidural analgesia. This pain has been described as constant, aching in quality, unrelated to position change or respiration. Possible causes of shoulder pain includes injury of the phrenic nerve, the lateral decubitus position, transection of major bronchus or preexisting arthritis condition. The possibilities of prevention and management of PISP are taken into consideration. Thoracic epidural block will be performed in all patients before general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parecoxib | Active comparator | Drug: ParecoxibParecoxib 2 ml intravenous |
| Control | Placebo comparator | Other: Control0.9% sodium chloride 2 ml intravenous |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiology (ASA) physical status I-III
- Undergoing pulmonary resection by open thoracotomy
Key exclusion criteria (9 listed)
- Unable to understand numeric rating scale despite preoperative coaching
- Preexisting shoulder pain at the same operative side
- Having contraindication for thoracic epidural analgesia
- History of previous myocardial ischemia or cerebrovascular accident
- Allergic to NSAIDS, sulfonamides or parecoxib
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 |
|---|---|---|
| ParecoxibAlso: DynastatParecoxib 40 mg intravenous before surgery and every 12 hours for two days. | Drug | Parecoxib |
| ControlNSS 2 ml intravenous before surgery and every 12 hours for two days. | Other | Control |
Primary outcome
Numeric rating scale (NRS) of shoulder pain and incisional pain at rest and movement
Time frame: at 2 ,6 ,12 ,24 ,48,72 and 96 hours after the operation
2 secondary outcomes
compare an amount of morphine consumption
Time frame: at 2,6 ,12,24,48,72 and 96 hours after the operation
adverse effect related to parecoxib
Time frame: during 96 hours
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 6 Dec 2016.
- Background: PubMed 17572327Bamgbade OA, Dorje P, Adhikary GS. The dual etiology of ipsilateral shoulder pain after thoracic surgery. J Clin Anesth. 2007 Jun;19(4):296-8. doi: 10.1016/j.jclinane.2006.09.010.
- Background: PubMed 18195603MacDougall P. Postthoracotomy shoulder pain: diagnosis and management. Curr Opin Anaesthesiol. 2008 Feb;21(1):12-5. doi: 10.1097/ACO.0b013e3282f2bb67.
- Individual participant dataSharing planned: No
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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.
Tanyong Pipanmekaporn, MD principal investigator
Department of Anesthesiology, Faculty of Medicine, Chiang Mai University , Chiang Mai, Thailand,50200
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Parecoxib in people with Shoulder Pain and Post-operative Pain, run by Chiang Mai University at 2 sites in Thailand.
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 9 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 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Numeric rating scale (NRS) of shoulder pain and incisional pain at rest and movement (time frame: at 2 ,6 ,12 ,24 ,48,72 and 96 hours after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01288924, which also lists 2 linked publications.
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 6 Dec 2016.