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The Effect of Dexamethasone Added to Bupivacain in Nasal Surgery

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ClinicalTrials.gov Identifier: NCT03036605
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmet Murat Yayik, Ataturk University

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.


Condition or disease Intervention/treatment Phase
Nasal Surgery Drug: Bupivacaine Drug: Dexamethasone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Postoperative Analgesic Effect of Dexamethasone Added to Topical Bupivacaine in Endoscopic Nasal Surgery
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : May 15, 2017


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 Name: 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 Name: Bupivacaine only

Drug: Dexamethasone
8 mg Dexamethasone
Other Name: Bupivacaine plus dexamethasone




Primary Outcome Measures :
  1. Analgesic consumption [ Time Frame: Postoperative 24 hours ]
    Analgesic consumption first 24 hours


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036605


Locations
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Turkey
Ataturk University
Erzurum, Yakutiye, Turkey, 25100
Sponsors and Collaborators
Ataturk University
Investigators
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Principal Investigator: Ahmet Murat Yayik, MD Ataturk University

Publications:
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Responsible Party: Ahmet Murat Yayik, MD, Ataturk University
ClinicalTrials.gov Identifier: NCT03036605     History of Changes
Other Study ID Numbers: Ataturk University
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ahmet Murat Yayik, Ataturk University:
dexamethasone
bupivacaine
nasal surgery
nasal packing

Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Bupivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents