Clinical trial NCT04512664: Different Cold Application Times on Ecchmosis, Edema and Pain After Rhinoplasty
Official title: Principal Investigator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhinoplasty
Cryotherapy Effect
Nurse's Role
Lead sponsor: University of Beykent
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, 2-group, Single-blind, Randomized clinical trial
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the effects of different cold application times with cold gel pads after rhinoplasty on eyelid edema, eye ecchymosis and pain. A total of 60 patients undergoing rhinoplasty were divided into two groups by simple randomization method. Cold application applied to short term group for 4 hours and to long term group for 48 hours. Cold application was applied around both eyes with cold gel pads for 20 minutes per hour. Pain was evaluated with the Visuel Analog Scale, ecchymosis with eyelid ecchymosis score, and edema with eye-edema score. Edema and ecchymosis were evaluated on the 1st and 4th hours and 2nd day. Pain conditions were evaluated before and after analgesics for 1, 4 hours and 2 times daily.

Detailed description: The research was carried out between January 2015 and March 2017 in an education and research hospital with a capacity of 26 beds. The research was suspended between July 2015 and January 2016. Patients who underwent rhinoplasty / septorhinoplasty operation between January 2015 and March 2017 with open or closed technique were included in the study. The study included patients who were 18 years of age or older who underwent a rhinoplasty / septorhinoplasty operation voluntarily. Patients who had cold allergy, refused to participate, applied outside of the research protocol and required re-operation in the early postoperative period due to complications were excluded from the study. All patients were provided with training and brochures for preoperative, intraoperative and postoperative periods. The cold application was done with gel pads of the same size and weight (13 cm x 13 cm-approximately 100 g) for 20 minutes per hour. Cold application was performed by the researcher in both groups for the first 4 hours. The patients in the short-term cold application group were given cold application by the researcher for 4 hours and 20 minutes per hour and the cold application was terminated. In the long-term application group, the first 4 hours of cold application were done by the researcher. Cold application after 4 hours; jel pads was applied at home by the patient's relative in accordance with the training given on the cold application protocol.

Eligibility criteria: Inclusion Criteria:

* aged 18 years or older
* who underwent rhinoplasty / septorhinoplasty
* voluntarily participated in the study

Exclusion Criteria:

* Patients with cold allergy,
* refused to participate,
* performed outside the research protocol,
* required early re-operation due to postoperative complications

Primary outcomes:
measure: Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 1st hour
timeFrame: Postoperative 1st hour
measure: Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 4th hour
timeFrame: Postoperative 4th hour
measure: Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 2nd day
timeFrame: Postoperative 2nd day
Secondary outcomes:
measure: Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 1st hour
timeFrame: postoperative 1st hour
measure: Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 4th hour
timeFrame: postoperative 4th hour
measure: Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 2nd day
timeFrame: postoperative 2nd day
Other outcomes:
measure: Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st hour
timeFrame: postoperative 1st hour
measure: Surgical Site Pain as assesed using 100 point-VAS: postoperative 4th hour
timeFrame: postoperative 4th hour
measure: Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st day morning before take the analgesic
timeFrame: postoperative 1st day morning before take the analgesic
measure: Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st day morning after take the analgesic
timeFrame: postoperative 1st day morning, 45 minutes after take the analgesic
measure: Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st day evening, before take the analgesic
timeFrame: postoperative 1st day evening, before take the analgesic
measure: Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st day evening after take the analgesic
timeFrame: postoperative 1st day evening, 45 minutes after take the analgesic
measure: Surgical Site Pain as assesed using 100 point-VAS: postoperative 2nd day morning before take the analgesic
timeFrame: postoperative 2nd day morning before take the analgesic
measure: Surgical Site Pain as assesed using 100 point-VAS: postoperative 2nd day after before take the analgesic
timeFrame: postoperative 2nd day after 45 minutes before take the analgesic
Locations:
Study officials:
affiliation: FACULTY MEMBER
name: YASEMİN EDA TEKİN, PHD
role: PRINCIPAL_INVESTIGATOR
References: