Nasal SurgeryPhase 4NCT03036605
The Effect of Dexamethasone Added to Bupivacain in Nasal Surgery
A Phase 4 study testing Bupivacaine and Dexamethasone in people with Nasal Surgery, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Nasal packing is frequently applied after nasal surgery. Nasal packing reduces epistaxis, prevents septal hematoma and stabilizes nasal septum. Nasal mucosa is quite sensitive to pain, therefore the most common problems after surgery are postoperative pain and anxiety during removal of the nasal packing. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasal Surgery
- What is being tested?
- Bupivacaine and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2017to 15 May 2017
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist's physiologic state I-II patients undergoing nasal surgery
Who cannot join
- chronic pain
- bleeding disorders
- renal or hepatic insufficiency
- patients on chronic non-steroidal anti-inflammatory medications
- emergency cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Postoperative Analgesic Effect of Dexamethasone Added to Topical Bupivacaine in Endoscopic Nasal Surgery
Nasal packing is frequently applied after nasal surgery. Nasal packing reduces epistaxis, prevents septal hematoma and stabilizes nasal septum. Nasal mucosa is quite sensitive to pain, therefore the most common problems after surgery are postoperative pain and anxiety during removal of the nasal packing. Lots of methods have been tried to control this pain (non-steroidal anti-inflammatory drugs, nerve blockade with long-acting local anesthetics, local anesthetics infiltration into nasal packing).
Glucocorticoids have been used as an adjuvant in the management of acute postoperative pain. Perineural dexamethasone as an adjuvant for the single-injection nerve block can prolong analgesia and reduce opioid-requiring after surgery. Furthermore dexamethasone reduces postoperative nausea and vomiting incidance.
- Conditions
- Nasal Surgery
- Being tested
- Bupivacaine, Dexamethasone
- Keywords
- dexamethasone, bupivacaine, nasal surgery, nasal packing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Bupivacaine only
%0.5 bupivacaine
DexamethasoneDrug
Also called Bupivacaine plus dexamethasone
8 mg Dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Group Bupivacaine | Active comparator | 4 ml %0.5 bupivacaine and 1 ml %0.9 NaCl infiltration into nasal packing to both sides Receives: Drug: Bupivacaine |
| Group Bupivacaine+Dexamethasone | Active comparator | 4 ml %0.5 bupivacaine and 4mg(1 ml) dexamethasone infiltration into nasal packing to both sides Receives: Drug: Bupivacaine; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic consumption
Analgesic consumption first 24 hours
Measured: Postoperative 24 hours
Secondary outcomes (6)
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively.
Measured: postoperative first hour
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively.
Measured: postoperative second hour
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively.
Measured: postoperative 4th hour
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively.
Measured: postoperative 8th hour
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively.
Measured: postoperative 12th hour
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively.
Measured: postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start15 Mar 2017
- Primary completion1 Apr 2017
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nasal SurgeryStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Murat Yayik, Ataturk University
- Investigators
- Ahmet Murat Yayik, MD, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036605
- Sponsor's protocol ID
- Ataturk University
- Status last verified
- Jun 2017
- First submitted
- 27 Jan 2017
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sahin C, Aras HI. Effect on patient anxiety of lidocaine infiltration into nasal packing after septoplasty: prospective, controlled study. J Laryngol Otol. 2015 Aug;129(8):784-7. doi: 10.1017/S0022215115001644. Epub 2015 Jun 29.
PubMed 26118324Yilmaz S, Kocaman Akbay B, Yildizbas S, Guclu E, Yaman H, Yalcin Sezen G. Efficacy of topical levobupivacaine in control of postoperative pain after septoplasty. J Otolaryngol Head Neck Surg. 2010 Aug;39(4):454-7.
PubMed 20643015De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.
PubMed 21799397Bjorn S, Linde F, Nielsen KK, Borglum J, Hauritz RW, Bendtsen TF. Effect of Perineural Dexamethasone on the Duration of Single Injection Saphenous Nerve Block for Analgesia After Major Ankle Surgery: A Randomized, Controlled Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):210-216. doi: 10.1097/AAP.0000000000000538.
PubMed 28033159
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Postoperative Analgesic Effect of Dexamethasone Added to Topical Bupivacaine in Endoscopic Nasal Surgery
- ClinicalTrials.gov ID
- NCT03036605
- Acronym / sponsor ID
- Ataturk University
- Conditions
- Nasal Surgery
- Keywords
- dexamethasone, bupivacaine, nasal surgery, nasal packing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 30 Jan 2017 (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.
Nasal packing is frequently applied after nasal surgery. Nasal packing reduces epistaxis, prevents septal hematoma and stabilizes nasal septum. Nasal mucosa is quite sensitive to pain, therefore the most common problems after surgery are postoperative pain and anxiety during removal of the nasal packing. Lots of methods have been tried to control this pain (non-steroidal anti-inflammatory drugs, nerve blockade with long-acting local anesthetics, local anesthetics infiltration into nasal packing).
Glucocorticoids have been used as an adjuvant in the management of acute postoperative pain. Perineural dexamethasone as an adjuvant for the single-injection nerve block can prolong analgesia and reduce opioid-requiring after surgery. Furthermore dexamethasone reduces postoperative nausea and vomiting incidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Bupivacaine | Active comparator | Drug: Bupivacaine4 ml %0.5 bupivacaine and 1 ml %0.9 NaCl infiltration into nasal packing to both sides |
| Group Bupivacaine+Dexamethasone | Active comparator | Drug: Bupivacaine, Drug: Dexamethasone4 ml %0.5 bupivacaine and 4mg(1 ml) dexamethasone infiltration into nasal packing to both sides |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologist's physiologic state I-II patients undergoing nasal surgery
Key exclusion criteria (5 listed)
- chronic pain
- bleeding disorders
- renal or hepatic insufficiency
- patients on chronic non-steroidal anti-inflammatory medications
- emergency cases
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 |
|---|---|---|
| BupivacaineAlso: Bupivacaine only%0.5 bupivacaine | Drug | Group Bupivacaine, Group Bupivacaine+Dexamethasone |
| DexamethasoneAlso: Bupivacaine plus dexamethasone8 mg Dexamethasone | Drug | Group Bupivacaine+Dexamethasone |
Primary outcome
Analgesic consumption
Time frame: Postoperative 24 hours
Analgesic consumption first 24 hours
6 secondary outcomes
Visual analog pain score
Time frame: postoperative first hour
Visual analog pain score
Time frame: postoperative second hour
Visual analog pain score
Time frame: postoperative 4th hour
Visual analog pain score
Time frame: postoperative 8th hour
Visual analog pain score
Time frame: postoperative 12th hour
Visual analog pain score
Time frame: postoperative 24th hour
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 7 Jun 2017.
- Background: PubMed 26118324Sahin C, Aras HI. Effect on patient anxiety of lidocaine infiltration into nasal packing after septoplasty: prospective, controlled study. J Laryngol Otol. 2015 Aug;129(8):784-7. doi: 10.1017/S0022215115001644. Epub 2015 Jun 29.
- Background: PubMed 20643015Yilmaz S, Kocaman Akbay B, Yildizbas S, Guclu E, Yaman H, Yalcin Sezen G. Efficacy of topical levobupivacaine in control of postoperative pain after septoplasty. J Otolaryngol Head Neck Surg. 2010 Aug;39(4):454-7.
- Background: PubMed 21799397De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.
- Background: PubMed 28033159Bjorn S, Linde F, Nielsen KK, Borglum J, Hauritz RW, Bendtsen TF. Effect of Perineural Dexamethasone on the Duration of Single Injection Saphenous Nerve Block for Analgesia After Major Ankle Surgery: A Randomized, Controlled Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):210-216. doi: 10.1097/AAP.0000000000000538.
- Individual participant dataSharing planned: Undecided
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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.
Ahmet Murat Yayik, MD principal investigator
Ataturk University
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 Bupivacaine and Dexamethasone in people with Nasal Surgery, run by Ataturk University at 1 site in Turkey (Türkiye).
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 1 inclusion and 5 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 7 Jun 2017. 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 Turkey (Türkiye). 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?
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?
Analgesic consumption (time frame: Postoperative 24 hours). 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 NCT03036605, which also lists 4 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 7 Jun 2017.