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Completed

NCT Number: NCT04512664

Different Cold Application Times on Ecchmosis, Edema and Pain After Rhinoplasty

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold Application

Other

cold application with gel pacs

Primary outcomes

  1. Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 1st hour

    Time frame: Postoperative 1st hour

    Bruising around the eye

  2. Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 4th hour

    Time frame: Postoperative 4th hour

    Bruising around the eye

  3. Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 2nd day

    Time frame: Postoperative 2nd day

    Bruising around the eye

Secondary outcomes

  1. Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 1st hour

    Time frame: postoperative 1st hour

    eyelid swelling

  2. Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 4th hour

    Time frame: postoperative 4th hour

    eyelid swelling

  3. Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 2nd day

    Time frame: postoperative 2nd day

    eyelid swelling

Other outcomes

  1. Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st hour

    Time frame: postoperative 1st hour

    Surgical site pain

  2. Surgical Site Pain as assesed using 100 point-VAS: postoperative 4th hour

    Time frame: postoperative 4th hour

    Surgical site pain

  3. Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st day morning before take the analgesic

    Time frame: postoperative 1st day morning before take the analgesic

    Surgical site pain

  4. Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st day morning after take the analgesic

    Time frame: postoperative 1st day morning, 45 minutes after take the analgesic

    Surgical site pain

  5. Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st day evening, before take the analgesic

    Time frame: postoperative 1st day evening, before take the analgesic

    Surgical site pain

  6. Surgical Site Pain as assesed using 100 point-VAS: postoperative 1st day evening after take the analgesic

    Time frame: postoperative 1st day evening, 45 minutes after take the analgesic

    Surgical site pain

  7. Surgical Site Pain as assesed using 100 point-VAS: postoperative 2nd day morning before take the analgesic

    Time frame: postoperative 2nd day morning before take the analgesic

    Surgical site pain

  8. Surgical Site Pain as assesed using 100 point-VAS: postoperative 2nd day after before take the analgesic

    Time frame: postoperative 2nd day after 45 minutes before take the analgesic

    Surgical site pain

Sponsors and collaborators

Lead sponsor

University of Beykent

Other

Registry information

Official study title

Principal Investigator

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 13, 2020
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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