Intra-operative Nasal Compression After Lateral Osteotomy to Minimize Post-operative Peri-orbital Ecchymosis and Edema

Rhinoplasty Clinical Trial

Official title:

Intra-operative Nasal Compression After Lateral Osteotomy to Minimize Post-operative Peri-orbital Ecchymosis and Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319954
• Other study ID #: HSREB 105768
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: November 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Periorbital edema and ecchymosis are common morbidities in the post-operative period after rhinoplasty. Lateral osteotomy techniques used to reshape the bony nasal pyramid are large contributing factors to the degree of bruising and edema. This is due to injury to the angular vessels that are crossing the osteotomy sites. Depending on the degree of swelling and bruising, it can cause difficulty with visual acuity in the early post-operative period. Most importantly, this can be quite distressing to the patient and impact the time required to return to normal social activities. Numerous studies have examined various interventions to reduce periorbital swelling and ecchymosis. These include peri-operative steroids, lidocaine with epinephrine injections, fibrin sealant, permissive intra-operative hypotension and subperiosteal osteotomy techniques. Peri-operative steroids have been most extensively studied. Recent meta-analysis by Hatef et al, found that pre-operative steroids were effective for decreasing post-operative edema and ecchymosis. Steroids however, carry with it the risks of psychosis, immunosuppression, weight gain, uncontrolled blood glucose and avascular necrosis of the hip. As such, broadly applicable and cost-effective techniques to minimize post-operative edema and ecchymosis without the risk profile of steroids would be ideal. Taskin et al. recently examined the efficacy of the combination of intraoperative cold saline-soaked gauze compression and corticosteroids on rhinoplasty morbidity. The study group received compression with a cold saline soaked gauze to the nasal dorsum during the surgery and the control group received compression with a dry gauze. Both groups received a pre-operative dose of intravenous steroids. The study group had significantly less periorbital edema and ecchymosis on post-operative days 1, 3, 5 and 7. This study unfortunately did not examine the role of compression alone and the study was performed in the presence of steroids, which is not routinely utilized by all surgeons. As such, the proposed study will provide evidence for the use of direct compression intra-operatively after lateral osteotomy in order to reduce post-operative edema and ecchymosis. The findings of this study may provide a simple, effective and non-costly technique to minimize the morbidity of rhinoplasty.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients (18 years old and greater) undergoing rhinoplasty requiring lateral osteotomy

Exclusion Criteria:

• Patients taking anti-coagulation medication, history of bleeding disorder and those who do not complete the follow-up schedule will be excluded from the study.

Related Conditions & MeSH terms

• Ecchymosis
• Rhinoplasty

Intervention

Procedure:
• Direct compression
Direct compression by the surgeon with their hands on the nasal sidewall

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

References & Publications (8)

Al-Arfaj A, Al-Qattan M, Al-Harethy S, Al-Zahrani K. Effect of periosteum elevation on periorbital ecchymosis in rhinoplasty. J Plast Reconstr Aesthet Surg. 2009 Nov;62(11):e538-9. doi: 10.1016/j.bjps.2008.05.047. Epub 2008 Oct 5. — View Citation

Gun R, Yorgancilar E, Yildirim M, Bakir S, Topcu I, Akkus Z. Effects of lidocaine and adrenaline combination on postoperative edema and ecchymosis in rhinoplasty. Int J Oral Maxillofac Surg. 2011 Jul;40(7):722-9. doi: 10.1016/j.ijom.2011.02.022. Epub 2011 Apr 1. — View Citation

Hatef DA, Ellsworth WA, Allen JN, Bullocks JM, Hollier LH Jr, Stal S. Perioperative steroids for minimizing edema and ecchymosis after rhinoplasty: a meta-analysis. Aesthet Surg J. 2011 Aug;31(6):648-57. doi: 10.1177/1090820X11416110. Review. — View Citation

Kara CO, Kara IG, Topuz B. Does creating a subperiosteal tunnel influence the periorbital edema and ecchymosis in rhinoplasty? J Oral Maxillofac Surg. 2005 Aug;63(8):1088-90. — View Citation

Kosucu M, Omür S, Besir A, Uraloglu M, Topbas M, Livaoglu M. Effects of perioperative remifentanil with controlled hypotension on intraoperative bleeding and postoperative edema and ecchymosis in open rhinoplasty. J Craniofac Surg. 2014 Mar;25(2):471-5. doi: 10.1097/SCS.0000000000000603. — View Citation

Taskin U, Yigit O, Bilici S, Kuvat SV, Sisman AS, Celebi S. Efficacy of the combination of intraoperative cold saline-soaked gauze compression and corticosteroids on rhinoplasty morbidity. Otolaryngol Head Neck Surg. 2011 May;144(5):698-702. doi: 10.1177/0194599811400377. — View Citation

Totonchi A, Guyuron B. A randomized, controlled comparison between arnica and steroids in the management of postrhinoplasty ecchymosis and edema. Plast Reconstr Surg. 2007 Jul;120(1):271-4. — View Citation

Tuncel U, Turan A, Bayraktar MA, Erkorkmaz U, Kostakoglu N. Efficacy of dexamethasone with controlled hypotension on intraoperative bleeding, postoperative oedema and ecchymosis in rhinoplasty. J Craniomaxillofac Surg. 2013 Mar;41(2):124-8. doi: 10.1016/j.jcms.2012.06.003. Epub 2012 Jul 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periorbital edema and ecchymosis	The primary outcome of this study is periorbital edema and ecchymosis. Post-operative photographs will be graded by two staff Otolaryngologists and two senior Otolaryngology residents. Each evaluator will be presented a photograph of a patient and be asked to grade the degree of periorbital edema and ecchymosis for the left and right side. Previously published grading scales will be used. The evaluators will be blinded to the allocated side of nasal pressure and to the post-operative day of the photographs.	up to 4 weeks