The Effect of Dexamethasone Added to Bupivacain in Nasal Surgery

June 6, 2017 updated by: Ahmet Murat Yayik, Ataturk University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yakutiye
      • Erzurum, Yakutiye, Turkey, 25100
        • Ataturk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group Bupivacaine
4 ml %0.5 bupivacaine and 1 ml %0.9 NaCl infiltration into nasal packing to both sides
Drug: Bupivacaine
%0.5 bupivacaine
Other Names:
  • Bupivacaine only
Active Comparator: Group Bupivacaine+Dexamethasone
4 ml %0.5 bupivacaine and 4mg(1 ml) dexamethasone infiltration into nasal packing to both sides
Drug: Bupivacaine
%0.5 bupivacaine
Other Names:
  • Bupivacaine only
Drug: Dexamethasone
8 mg Dexamethasone
Other Names:
  • Bupivacaine plus dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic consumption
Time Frame: Postoperative 24 hours
Analgesic consumption first 24 hours
Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog pain score
Time Frame: postoperative first hour
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.
postoperative first hour
Visual analog pain score
Time Frame: postoperative second hour
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.
postoperative second hour
Visual analog pain score
Time Frame: postoperative 4th hour
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.
postoperative 4th hour
Visual analog pain score
Time Frame: postoperative 8th hour
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.
postoperative 8th hour
Visual analog pain score
Time Frame: postoperative 12th hour
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.
postoperative 12th hour
Visual analog pain score
Time Frame: postoperative 24th hour
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.
postoperative 24th hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Principal Investigator: Ahmet Murat Yayik, MD, Ataturk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2017

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

May 15, 2017

Study Registration Dates

First Submitted

January 27, 2017

First Submitted That Met QC Criteria

January 27, 2017

First Posted (Estimate)

January 30, 2017

Study Record Updates

Last Update Posted (Actual)

June 7, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ataturk university

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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