The Effect of Dexamethasone Added to Bupivacain in Nasal Surgery

Phase 4

Completed

• Conditions: Nasal Surgery
• Interventions: Drug: Bupivacaine; Drug: Dexamethasone

• Registration Number: NCT03036605
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-27
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-30
• Study Start: 2017-03-15
• Primary Completion: 2017-04-01
• Study Completion: 2017-05-15
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Bupivacaine+Dexamethasone	Bupivacaine	4 ml %0.5 bupivacaine and 4mg(1 ml) dexamethasone infiltration into nasal packing to both sides
Group Bupivacaine+Dexamethasone	Dexamethasone	4 ml %0.5 bupivacaine and 4mg(1 ml) dexamethasone infiltration into nasal packing to both sides
Group Bupivacaine	Bupivacaine	4 ml %0.5 bupivacaine and 1 ml %0.9 NaCl infiltration into nasal packing to both sides

Primary Outcome Measures

Name	Time	Method
Analgesic consumption	Postoperative 24 hours	Analgesic consumption first 24 hours

Secondary Outcome Measures

Name	Time	Method
Visual analog pain score	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.

Trial Locations

Locations (1)

Ataturk University; 🇹🇷 Erzurum, Yakutiye, Turkey