Pain Control After Functional Endoscopic Sinus Surgery and SeptoplastyPhase 4NCT03605914
Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
A Phase 4 study testing diclofenac and Norco in people with Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to compare the level of pain control in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) to those receiving opioids in the postoperative period after endoscopic sinus surgery (ESS) and/or septoplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
- What is being tested?
- diclofenac and Norco
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 5 Jul 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- english speaking
- candidates for endoscopic sinus surgery as determined by medical necessity by the treating rhinologist
- scheduled for surgery at Texas Sinus Institute
Who cannot join
- allergy to either NSAIDs or opioids
- contraindication to NSAIDs (ex. gastritis, chronic kidney disease)
- surgical plan exceeding basic endoscopic sinus surgery
- use of anticoagulation
- the presence of any pain disorder
- the current usage of any analgesic medication
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- history of opioid addiction
- pregnancy
- history of chronic pain or fibromyalgia
- current daily use of NSAIDs, acetaminophen, opioids or other analgesics (pregabalin, tramadol, etc)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to compare the level of pain control in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) to those receiving opioids in the postoperative period after endoscopic sinus surgery (ESS) and/or septoplasty.
- Being tested
- diclofenac, Norco
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diclofenacDrug
The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
NorcoDrug
Also called Hydrocodone-Acetaminophen combination medication
The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
| Study group | Role | What they receive |
|---|---|---|
| NSAID | Experimental | The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac. Receives: Drug: diclofenac |
| opioid | Active comparator | The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen). Receives: Drug: Norco |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
Measured: 24 hours (day 1 after operation)
Secondary outcomes (6)
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
Measured: 48 hours (day 2 after operation)
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
Measured: 72 hours (day 3 after operation)
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
Measured: 120 hours (day 5 after operation)
Number of Participants With Bleeding Complications
Bleeding complications are defined as complications necessitating a trip to the emergency room or requiring intervention for epistaxis.
Measured: 5 days after operation
Number of Participants With Constipation
Measured: 5 days after operation
Number of Participants With Nausea or Vomiting
Measured: 5 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start1 Aug 2018
- Primary completion1 Jul 2020
- Study completion5 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain Control After Functional Endoscopic Sinus Surgery and SeptoplastyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin J Citardi, MD, The University of Texas Health Science Center, Houston
- Investigators
- Martin Citardi, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605914
- Sponsor's protocol ID
- HSC-MS-18-0242
- Status last verified
- Jul 2021
- First submitted
- 4 Jul 2018
- Last updated
- 20 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
- ClinicalTrials.gov ID
- NCT03605914
- Acronym / sponsor ID
- HSC-MS-18-0242
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 5 Jul 2020 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Posted 20 Jul 2021
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 level of pain control in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) to those receiving opioids in the postoperative period after endoscopic sinus surgery (ESS) and/or septoplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSAID | Experimental | Drug: diclofenacThe non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac. |
| opioid | Active comparator | Drug: NorcoThe Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- english speaking
- candidates for endoscopic sinus surgery as determined by medical necessity by the treating rhinologist
- scheduled for surgery at Texas Sinus Institute
Key exclusion criteria (10 listed)
- allergy to either NSAIDs or opioids
- contraindication to NSAIDs (ex. gastritis, chronic kidney disease)
- surgical plan exceeding basic endoscopic sinus surgery
- use of anticoagulation
- the presence of any pain disorder
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 |
|---|---|---|
| diclofenacThe non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac. | Drug | NSAID |
| NorcoAlso: Hydrocodone-Acetaminophen combination medicationThe opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen). | Drug | opioid |
Primary outcome
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
Time frame: 24 hours (day 1 after operation)
The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain.
6 secondary outcomes
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
Time frame: 48 hours (day 2 after operation)
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
Time frame: 72 hours (day 3 after operation)
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
Time frame: 120 hours (day 5 after operation)
Number of Participants With Bleeding Complications
Time frame: 5 days after operation
Number of Participants With Constipation
Time frame: 5 days after operation
Number of Participants With Nausea or Vomiting
Time frame: 5 days after operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Martin Citardi, MD principal investigator
The University of Texas Health Science Center, Houston
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 diclofenac and Norco in people with Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 10 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 20 Jul 2021. 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 United States. 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.
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?
Yes. Results are posted in the registry (first posted 20 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS) (time frame: 24 hours (day 1 after 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 20 Jul 2021.