NCT03036605

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2017

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

17 days

First QC Date

January 27, 2017

Last Update Submit

June 6, 2017

Conditions

Nasal Surgery

Keywords

dexamethasonebupivacainenasal surgerynasal packing

Outcome Measures

Primary Outcomes (1)

  • Analgesic consumption

    Analgesic consumption first 24 hours

    Postoperative 24 hours

Secondary Outcomes (6)

  • Visual analog pain score

    postoperative first hour

  • Visual analog pain score

    postoperative second hour

  • Visual analog pain score

    postoperative 4th hour

  • Visual analog pain score

    postoperative 8th hour

  • Visual analog pain score

    postoperative 12th hour

  • +1 more secondary outcomes

Study Arms (2)

Group Bupivacaine

ACTIVE COMPARATOR

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

Drug: Bupivacaine

Group Bupivacaine+Dexamethasone

ACTIVE COMPARATOR

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

Drug: BupivacaineDrug: Dexamethasone

Interventions

BupivacaineDRUG

%0.5 bupivacaine

Also known as: Bupivacaine only
Group BupivacaineGroup Bupivacaine+Dexamethasone
DexamethasoneDRUG

8 mg Dexamethasone

Also known as: Bupivacaine plus dexamethasone
Group Bupivacaine+Dexamethasone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • chronic pain
  • bleeding disorders
  • renal or hepatic insufficiency
  • patients on chronic non-steroidal anti-inflammatory medications
  • emergency cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 26118324BACKGROUND

  • 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.

    PMID: 20643015BACKGROUND

  • 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.

    PMID: 21799397BACKGROUND

  • 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.

    PMID: 28033159BACKGROUND

MeSH Terms

Interventions

BupivacaineDexamethasone

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Ahmet Murat Yayik, MD

    Ataturk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 27, 2017

First Posted

January 30, 2017

Study Start

March 15, 2017

Primary Completion

April 1, 2017

Study Completion

May 15, 2017

Last Updated

June 7, 2017

Record last verified: 2017-06

Locations

TU(1)