The Effect of Dexamethasone Added to Bupivacain in Nasal Surgery

NCT ID: NCT03036605

Last Updated: 2017-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2017-05-15

Brief Summary

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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.

Detailed Description

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Conditions

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Nasal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group Bupivacaine

4 ml %0.5 bupivacaine and 1 ml %0.9 NaCl infiltration into nasal packing to both sides

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

%0.5 bupivacaine

Group Bupivacaine+Dexamethasone

4 ml %0.5 bupivacaine and 4mg(1 ml) dexamethasone infiltration into nasal packing to both sides

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

%0.5 bupivacaine

Dexamethasone

Intervention Type DRUG

8 mg Dexamethasone

Interventions

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Bupivacaine

%0.5 bupivacaine

Intervention Type DRUG

Dexamethasone

8 mg Dexamethasone

Intervention Type DRUG

Other Intervention Names

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Bupivacaine only Bupivacaine plus dexamethasone

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologist's physiologic state I-II patients undergoing nasal surgery

Exclusion Criteria

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* emergency cases
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Ahmet Murat Yayik

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmet Murat Yayik, MD

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Locations

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Ataturk University

Erzurum, Yakutiye, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 26118324 (View on PubMed)

Yilmaz 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.

Reference Type BACKGROUND
PMID: 20643015 (View on PubMed)

De 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.

Reference Type BACKGROUND
PMID: 21799397 (View on PubMed)

Bjorn 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.

Reference Type BACKGROUND
PMID: 28033159 (View on PubMed)

Other Identifiers

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Ataturk University

Identifier Type: -

Identifier Source: org_study_id

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