NCT07015229

Brief Summary

To provide scientific contribution to more effective and timely pain management strategies in the postoperative period by evaluating the time-dependent course of pain scores and the effect of analgesic intervention timing on clinical outcomes in patients who underwent septorhinoplasty and who are followed in the postanesthetic care unit.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

June 25, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2026

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2026

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 3, 2025

Last Update Submit

June 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • visual analogue scale

    0:no pain, 10:worst pain

    60 minutes

Interventions

To provide scientific contribution to more effective and timely pain management strategies in the postoperative period by evaluating the time-dependent course of pain scores and the effect of analgesic intervention timing on clinical outcomes in patients who underwent septorhinoplasty and who are followed in the postanesthetic care unit.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 18-65 years with ASA 1-3 who underwent elective septorhinoplasty

You may qualify if:

  • Being 18 years of age or older,
  • Being in ASA I-III class,
  • Having undergone septorhinoplasty surgery under general anesthesia under elective conditions,
  • Being monitored for at least 30 minutes in postoperative,
  • Being conscious and able to assess pain with VAS.

You may not qualify if:

  • Patients who have undergone surgical procedures other than septorhinoplasty (e.g. laparoscopic, gynecological, orthopedic, etc.)
  • Inability to assess pain due to impaired consciousness, agitation, or sedation in the postoperative period
  • History of opioid derivatives or continuous analgesic use in the preoperative period
  • Cognitive impairment, psychiatric disease at a level that prevents communication, severe visual or hearing impairment
  • History of neurological or neuromuscular disease
  • Having undergone revision septorhinoplasty or other revision surgery
  • Patients with VAS≥4 during their follow-up in the postoperative,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Alshehri AA. Comparative Evaluation of Postoperative Pain Scores and Opioid Consumption in Septorhinoplasty After Administration of Single-Dose Preemptive Paracetamol and Ibuprofen: A Randomized Controlled Trial. Int Arch Otorhinolaryngol. 2023 Aug 4;27(3):e471-e477. doi: 10.1055/s-0042-1749386. eCollection 2023 Jul.

  • Perianez CAH, Castillo-Diaz MA, Barbosa MH, De Mattia AL. Pain Predictors in Patients in the Postanesthesia Care Unit. J Perianesth Nurs. 2024 Aug;39(4):652-658. doi: 10.1016/j.jopan.2023.11.010. Epub 2024 Feb 3.

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc. prof.

Study Record Dates

First Submitted

June 3, 2025

First Posted

June 11, 2025

Study Start

June 25, 2025

Primary Completion

January 4, 2026

Study Completion

January 20, 2026

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share