Clinical trial NCT03036605: The Effect of Dexamethasone Added to Bupivacain in Nasal Surgery
Official title: The Postoperative Analgesic Effect of Dexamethasone Added to Topical Bupivacaine in Endoscopic Nasal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nasal Surgery
Keywords: dexamethasone
bupivacaine
nasal surgery
nasal packing
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Analgesic consumption
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Visual analog pain score
timeFrame: postoperative first hour
measure: Visual analog pain score
timeFrame: postoperative second hour
measure: Visual analog pain score
timeFrame: postoperative 4th hour
measure: Visual analog pain score
timeFrame: postoperative 8th hour
measure: Visual analog pain score
timeFrame: postoperative 12th hour
measure: Visual analog pain score
timeFrame: postoperative 24th hour
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
state: Yakutiye
Study officials:
affiliation: Ataturk University
name: Ahmet Murat Yayik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.