NCT05671237

Brief Summary

The aim of our study is to examine the effect of bilateral infraorbital and infratrochlear nerve blocks for rhinoplasty operations on perioperative remifentanil need and postoperative pain scores.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 11, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

January 1, 2023

Last Update Submit

June 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Remifentanil consumption

    We will compare the remifentanil consumption for the block performed and non-block group

    6 hours

Secondary Outcomes (5)

  • Surgical bleeding grading

    6 hours

  • Richmond agitation sedation scale

    6 hours

  • Numeric rating Scale

    6 hours

  • Post-operative nausea and vomiting

    6 hours

  • Need for analgesic after surgery

    6 hours

Study Arms (2)

bilateral infraorbital+infratrochlear block group

EXPERIMENTAL

For this group we will perform bilateral infraorbital+infratrochlear block before surgery

Other: bilateral infraorbital+infratrochlear block

non-block group

NO INTERVENTION

For this group we will start the surgery without performing a block

Interventions

we will perform bilateral infraorbital+infratrochlear nerve block

bilateral infraorbital+infratrochlear block group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing rhinoplasty surgery

You may not qualify if:

  • Bleeding disorder
  • Patient refusal
  • Age under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Department of Anesthesiology

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (2)

  • Boselli E, Bouvet L, Augris-Mathieu C, Begou G, Diot-Junique N, Rahali N, Vertu-Ciolino D, Gerard C, Pivot C, Disant F, Allaouchiche B. Infraorbital and infratrochlear nerve blocks combined with general anaesthesia for outpatient rhinoseptoplasty: A prospective randomised, double-blind, placebo-controlled study. Anaesth Crit Care Pain Med. 2016 Feb;35(1):31-36. doi: 10.1016/j.accpm.2015.09.002. Epub 2015 Nov 5.

    PMID: 26549134BACKGROUND
  • Choi H, Jung SH, Hong JM, Joo YH, Kim Y, Hong SH. Effects of Bilateral Infraorbital and Infratrochlear Nerve Block on Emergence Agitation after Septorhinoplasty: A Randomized Controlled Trial. J Clin Med. 2019 May 30;8(6):769. doi: 10.3390/jcm8060769.

    PMID: 31151239BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 1, 2023

First Posted

January 4, 2023

Study Start

November 11, 2022

Primary Completion

February 15, 2023

Study Completion

March 1, 2023

Last Updated

June 5, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations