Evaluation of Preventive Photobiomodulation in Postoperative Rhinoplasty Edema

Not Applicable

Not yet recruiting

• Conditions: Rhinoplasty; Edema

• Registration Number: NCT07033039
• Lead Sponsor: University of Nove de Julho

Brief Summary

This randomized, double-blind clinical trial aims to evaluate the efficacy of preoperative photobiomodulation (PBM) in reducing periorbital edema following rhinoplasty. Sixty patients will be randomly assigned to a PBM or control group. The PBM group will receive low-level laser therapy preoperatively at specific facial sites using a red (660 nm) and infrared (808 nm) laser cluster. Edema will be assessed via standardized scales and ImageJ software analysis. Secondary variables will include ecchymosis, pain sensitivity, skin thickness, and analgesic medication count. Additionally, a standardized and validated questionnaire for the Portuguese language, SCHNOS, will be used to evaluate aesthetic and functional outcomes in patients undergoing rhinoplasty. Assessments will be conducted during postoperative follow-up visits scheduled for days 3, 7, 30, 60, and 90, as well as at 6 and 12 months. Adverse effects will be recorded and reported. Statistical analysis will apply ANOVA, Friedman, and chi-square tests, with significance set at p \< 0.05.

Detailed Description

Edema and ecchymosis are frequent postoperative manifestations of rhinoplasty, influenced by various factors such as the surgical technique used, pre and postoperative care, and the individual characteristics of patients. The prevention or early reduction of these conditions can have a significant impact on recovery, increasing patient satisfaction and accelerating the return to daily activities. Photobiomodulation (PBM) is recognized for its ability to reduce pain, modulate inflammation, and optimize tissue repair. Although studies have demonstrated the effectiveness of PBM in various clinical scenarios, such as wound treatment and postoperative pain management, its application in the specific context of rhinoplasty postoperative recovery remains underexplored. The objective of this study is to evaluate the effectiveness of PBM in reducing periorbital edema in patients undergoing rhinoplasty. For this purpose, 60 patients will be randomly divided into two groups: Control Group (n = 30) - patients will receive conventional treatment with a sham PBM application, and PBM Group (n = 30) - patients will receive conventional treatment and PBM application preoperatively at three cluster application sites, corresponding to the dorsal region and the frontal processes of the maxilla (right and left).. The treatment will be performed using a cluster with 3 red laser emitters (660 nm, 150 mW each) and 3 infrared laser emitters (808 nm, 150 mW each), applying 12 J per point (per laser) for 80 seconds. Edema will be assessed using the Hoffman visual scale and photographic records processed with the ImageJ software. Secondary variables will include ecchymosis, pain sensitivity, skin thickness, and analgesic medication count. Additionally, a standardized and validated questionnaire for the Portuguese language, SCHNOS, will be used to evaluate aesthetic and functional outcomes in patients undergoing rhinoplasty. Assessments will be conducted during postoperative follow-up visits scheduled for days 3, 7, 30, 60, and 90, as well as at 6 and 12 months. Adverse effects will be recorded and reported. Statistical analyses will be conducted using GraphPad Prism 5, with a significance level of p \< 0.05. Normality will be assessed using the Shapiro-Wilk test. Normally distributed data will be presented as mean ± SD and analyzed using repeated measures ANOVA, while non-normal data will be expressed as median and IQR and analyzed using the Friedman test. The paired t-test will be used for ImageJ photo analysis, and the chi-square test or Fisher's exact test for categorical SCHNOS data.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-13
• Study First Submitted QC: 2025-06-13
• Last Update Submitted: 2025-06-13
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24
• Study Start: 2025-10-30
• Primary Completion: 2029-11-30
• Study Completion: 2030-07-30

Recruitment & Eligibility

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

Inclusion Criteria

ASA physical status I or II

No comorbidities or pre-existing medical conditions

Scheduled for primary rhinoplasty -

Exclusion Criteria

Use of anticoagulant, anti-inflammatory, or corticosteroid medications

Indications for secondary or revision rhinoplasty

Indications for closed rhinoplasty

Surgical procedures performed using instruments other than a 3 mm curved angled osteotome with a guide for osteotomies

The occurrence of intraoperative complications, such as hemorrhage or technical difficulties

History of previous nasal filler procedures with hyaluronic acid

Use of vitamin A derivatives (e.g., oral isotretinoin or topical retinoic acid) within 30 days before surgery

Known allergy to any medications listed as mandatory for intraoperative or postoperative care

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Periorbital Edema on Postoperative baseline	baseline	Edema will be assessed on postoperative day using the Hoffmann et al. (1991) visual grading scale, scored by a calibrated evaluator. Standardized photographic records will be analyzed using ImageJ software to support visual assessment. This method is validated for edema assessment following rhinoplasty procedures.
Periorbital Edema on Postoperative Day 3	3 days postoperatively	Edema will be assessed on postoperative day using the Hoffmann et al. (1991) visual grading scale, scored by a calibrated evaluator. Standardized photographic records will be analyzed using ImageJ software to support visual assessment. This method is validated for edema assessment following rhinoplasty procedures.

Secondary Outcome Measures

Name	Time	Method
Analgesic Consumption 12 months	12 months	The total amount of analgesic medication ingested by each patient will be recorded to evaluate the impact of PBM on postoperative pain control. This outcome will be used as an indirect indicator of intervention efficacy.
Periorbital Edema on Postoperative Day 7	7 days postoperatively	Edema will be assessed on postoperative day using the Hoffmann et al. (1991) visual grading scale, scored by a calibrated evaluator. Standardized photographic records will be analyzed using ImageJ software to support visual assessment. This method is validated for edema assessment following rhinoplasty procedures.
Periorbital Edema on Postoperative Day 30	30 days postoperatively	Edema will be assessed on postoperative day using the Hoffmann et al. (1991) visual grading scale, scored by a calibrated evaluator. Standardized photographic records will be analyzed using ImageJ software to support visual assessment. This method is validated for edema assessment following rhinoplasty procedures.
Periorbital Edema on Postoperative Day 60	60 days postoperatively	Edema will be assessed on postoperative day using the Hoffmann et al. (1991) visual grading scale, scored by a calibrated evaluator. Standardized photographic records will be analyzed using ImageJ software to support visual assessment. This method is validated for edema assessment following rhinoplasty procedures.
Periorbital Edema on Postoperative 6 months	6 months postoperatively	Edema will be assessed on postoperative day using the Hoffmann et al. (1991) visual grading scale, scored by a calibrated evaluator. Standardized photographic records will be analyzed using ImageJ software to support visual assessment. This method is validated for edema assessment following rhinoplasty procedures.
Periorbital Edema on Postoperative 12 months	12 months postoperatively	Edema will be assessed on postoperative day using the Hoffmann et al. (1991) visual grading scale, scored by a calibrated evaluator. Standardized photographic records will be analyzed using ImageJ software to support visual assessment. This method is validated for edema assessment following rhinoplasty procedures.
Periorbital Ecchymosis baseline	baseline	Ecchymosis will be evaluated using the Hoffmann et al. (1991) scale and analysis of standardized photographic records processed in ImageJ software. Assessments will be performed by a calibrated examiner blinded to group allocation.
Periorbital Ecchymosis Day 7	7 days postoperatively	Ecchymosis will be evaluated using the Hoffmann et al. (1991) scale and analysis of standardized photographic records processed in ImageJ software. Assessments will be performed by a calibrated examiner blinded to group allocation.
Periorbital Ecchymosis Day 30	30 days postoperatively	Ecchymosis will be evaluated using the Hoffmann et al. (1991) scale and analysis of standardized photographic records processed in ImageJ software. Assessments will be performed by a calibrated examiner blinded to group allocation.
Periorbital Ecchymosis Day 60	60 days postoperatively	Ecchymosis will be evaluated using the Hoffmann et al. (1991) scale and analysis of standardized photographic records processed in ImageJ software. Assessments will be performed by a calibrated examiner blinded to group allocation.
Periorbital Ecchymosis 6 months	6 months postoperatively	Ecchymosis will be evaluated using the Hoffmann et al. (1991) scale and analysis of standardized photographic records processed in ImageJ software. Assessments will be performed by a calibrated examiner blinded to group allocation.
Periorbital Ecchymosis 12 months	12 months postoperatively	Ecchymosis will be evaluated using the Hoffmann et al. (1991) scale and analysis of standardized photographic records processed in ImageJ software. Assessments will be performed by a calibrated examiner blinded to group allocation.
Skin Thickness at the Nasal Tip baseline	baseline	Skin thickness will be assessed through physical examination of the nasal tip using a standardized protocol. The evaluations will be conducted by a trained clinician during scheduled follow-up visits.
Skin Thickness at the Nasal Tip Day 7	7 days postoperatively	Skin thickness will be assessed through physical examination of the nasal tip using a standardized protocol. The evaluations will be conducted by a trained clinician during scheduled follow-up visits.
Skin Thickness at the Nasal Tip Day 30	30 days postoperatively	Skin thickness will be assessed through physical examination of the nasal tip using a standardized protocol. The evaluations will be conducted by a trained clinician during scheduled follow-up visits.
Skin Thickness at the Nasal Tip Day 60	60 days postoperatively	Skin thickness will be assessed through physical examination of the nasal tip using a standardized protocol. The evaluations will be conducted by a trained clinician during scheduled follow-up visits.
Skin Thickness at the Nasal Tip 6 months	6 months postoperatively	Skin thickness will be assessed through physical examination of the nasal tip using a standardized protocol. The evaluations will be conducted by a trained clinician during scheduled follow-up visits.
Skin Thickness at the Nasal Tip 12 months	12 months postoperatively	Skin thickness will be assessed through physical examination of the nasal tip using a standardized protocol. The evaluations will be conducted by a trained clinician during scheduled follow-up visits.
Pain Sensitivity baseline	baseline	Postoperative pain will be assessed using the Visual Analog Scale (VAS), a validated tool commonly used in rhinoplasty research. A 10 cm horizontal ruler will be used, with endpoints labeled "0" (no pain) and "10" (worst imaginable pain),. All participants will use the same standardized ruler.
Pain Sensitivity Day 7	7 days postoperatively	Postoperative pain will be assessed using the Visual Analog Scale (VAS), a validated tool commonly used in rhinoplasty research. A 10 cm horizontal ruler will be used, with endpoints labeled "0" (no pain) and "10" (worst imaginable pain),. All participants will use the same standardized ruler.
Pain Sensitivity Day 30	Day 30 postoperatively	Postoperative pain will be assessed using the Visual Analog Scale (VAS), a validated tool commonly used in rhinoplasty research. A 10 cm horizontal ruler will be used, with endpoints labeled "0" (no pain) and "10" (worst imaginable pain),. All participants will use the same standardized ruler.
Pain Sensitivity Day 60	Day 60 postoperatively	Postoperative pain will be assessed using the Visual Analog Scale (VAS), a validated tool commonly used in rhinoplasty research. A 10 cm horizontal ruler will be used, with endpoints labeled "0" (no pain) and "10" (worst imaginable pain),. All participants will use the same standardized ruler.
Pain Sensitivity 6 months	6 months postoperatively	Postoperative pain will be assessed using the Visual Analog Scale (VAS), a validated tool commonly used in rhinoplasty research. A 10 cm horizontal ruler will be used, with endpoints labeled "0" (no pain) and "10" (worst imaginable pain),. All participants will use the same standardized ruler.
Pain Sensitivity 12 months	12 months postoperatively	Postoperative pain will be assessed using the Visual Analog Scale (VAS), a validated tool commonly used in rhinoplasty research. A 10 cm horizontal ruler will be used, with endpoints labeled "0" (no pain) and "10" (worst imaginable pain),. All participants will use the same standardized ruler.
Patient-Reported Functional and Aesthetic Outcomes baseline	baseline	Patients' perceptions of nasal function and cosmetic outcomes will be assessed using the SCHNOS (Standardized Cosmesis and Health Nasal Outcomes Survey), a validated questionnaire adapted for Brazilian Portuguese. Assessments will be performed preoperatively and at all designated postoperative time points.
Patient-Reported Functional and Aesthetic Outcomes Day 7	Day 7	Patients' perceptions of nasal function and cosmetic outcomes will be assessed using the SCHNOS (Standardized Cosmesis and Health Nasal Outcomes Survey), a validated questionnaire adapted for Brazilian Portuguese. Assessments will be performed preoperatively and at all designated postoperative time points.
Patient-Reported Functional and Aesthetic Outcomes Day 30	Day 30	Patients' perceptions of nasal function and cosmetic outcomes will be assessed using the SCHNOS (Standardized Cosmesis and Health Nasal Outcomes Survey), a validated questionnaire adapted for Brazilian Portuguese. Assessments will be performed preoperatively and at all designated postoperative time points.
Patient-Reported Functional and Aesthetic Outcomes Day 60	Day 60	Patients' perceptions of nasal function and cosmetic outcomes will be assessed using the SCHNOS (Standardized Cosmesis and Health Nasal Outcomes Survey), a validated questionnaire adapted for Brazilian Portuguese. Assessments will be performed preoperatively and at all designated postoperative time points.
Patient-Reported Functional and Aesthetic Outcomes 6 months	6 months	Patients' perceptions of nasal function and cosmetic outcomes will be assessed using the SCHNOS (Standardized Cosmesis and Health Nasal Outcomes Survey), a validated questionnaire adapted for Brazilian Portuguese. Assessments will be performed preoperatively and at all designated postoperative time points.
Patient-Reported Functional and Aesthetic Outcomes 12 months	12 months	Patients' perceptions of nasal function and cosmetic outcomes will be assessed using the SCHNOS (Standardized Cosmesis and Health Nasal Outcomes Survey), a validated questionnaire adapted for Brazilian Portuguese. Assessments will be performed preoperatively and at all designated postoperative time points.
Analgesic Consumption Baseline	Baseline	The total amount of analgesic medication ingested by each patient will be recorded to evaluate the impact of PBM on postoperative pain control. This outcome will be used as an indirect indicator of intervention efficacy.
Analgesic Consumption Day 7	Day 7	The total amount of analgesic medication ingested by each patient will be recorded to evaluate the impact of PBM on postoperative pain control. This outcome will be used as an indirect indicator of intervention efficacy.
Analgesic Consumption Day 30	Day 30	The total amount of analgesic medication ingested by each patient will be recorded to evaluate the impact of PBM on postoperative pain control. This outcome will be used as an indirect indicator of intervention efficacy.
Analgesic Consumption Day 60	Day 60	The total amount of analgesic medication ingested by each patient will be recorded to evaluate the impact of PBM on postoperative pain control. This outcome will be used as an indirect indicator of intervention efficacy.
Analgesic Consumption 6 months	6 months	The total amount of analgesic medication ingested by each patient will be recorded to evaluate the impact of PBM on postoperative pain control. This outcome will be used as an indirect indicator of intervention efficacy.