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CompletedNCT05671237Updated Jun 5, 2023

The Effect of Bilateral Infraorbital+ Infratrochlear Nerve Block for Rhinoplasty Operations

An interventional study of bilateral infraorbital+infratrochlear block in Anesthesia, Local, sponsored by Istanbul University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-05.

Sponsored by Istanbul University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Rhinoplasty operations are one of the most applied cosmetic surgeries in the world.

Depending on the procedure type and hemodynamic lability, the quality of the surgical field, perioperative and postoperative complications as well as the success of surgery are affected.To provide improved surgical field quality, controlled hypotension and high concentrations of inhalation anesthetics, magnesium sulfate, remifentanil, clonidine, calcium channel blockers, tranexamic acid, intravenous nitroglycerin have been used.

The American Society of Anesthesiology recommends using regional anesthesia methods and administering multimodal analgesia in every possible surgery. In our study we have performed bilaterral infraorbital an infratrochlear nerve blocks which are main nerves of the nose, for the patients of rhinoplasty. With blocking the infratrochlear and infraorbital nerves we will examine the need for remifentanil during surgery, postoperative pain scores.

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Conditions studied

  • Anesthesia, Local
03

In context

Lead sponsor

Istanbul University is the lead sponsor of 496 studies on the registry; 80 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Patients undergoing rhinoplasty surgery

Exclusion criteria

Exclusion Criteria:

  • Bleeding disorder
  • Patient refusal
  • Age under 18
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    bilateral infraorbital+infratrochlear block group

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

    Other: bilateral infraorbital+infratrochlear block

  • No intervention
    non-block group

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

Interventions

  • Otherbilateral infraorbital+infratrochlear block

    we will perform bilateral infraorbital+infratrochlear nerve block

06

What researchers measure

Primary outcomes

  1. Remifentanil consumption

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

    Time frame: 6 hours

Secondary outcomes

  1. Surgical bleeding grading

    We will compare the surgical bleeding scores for the block performed and non-block group

    Time frame: 6 hours

  2. Richmond agitation sedation scale

    We will compare the Richmond agitation sedation scale for the block performed and non-block group. +4 Combative +3 Very agitated +2 Agitated +1 Restless 0 Alert and calm -1 Drowsy -2 Light sedation -3 Moderate sedation -4 Deep sedation -5 Unarousable

    Time frame: 6 hours

  3. Numeric rating Scale

    We will compare the numeric rating scale for pain for the block performed and non-block group. The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

    Time frame: 6 hours

  4. Post-operative nausea and vomiting

    We will compare the Post-operative nausea and vomiting for the block performed and non-block group

    Time frame: 6 hours

  5. Need for analgesic after surgery

    We will compare the Need for analgesic after surgery for the block performed and non-block group

    Time frame: 6 hours

07

Study locations

1 site
  • Istanbul University, Department of Anesthesiology
    Istanbul, 34093, Turkey
08

References and documents

Publications

  • 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. PubMed 26549134 ↗
  • 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. PubMed 31151239 ↗

Related links

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05671237
Lead sponsor
Istanbul University
Responsible party
Reyhan Nil Kırsan (Principal Investigator, Istanbul University) — Principal investigator
First posted
Jan 4, 2023
Start date
Nov 11, 2022
Primary completion
Feb 15, 2023
Completion
Mar 1, 2023
Last update
Jun 5, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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