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

The Effect of Bilateral Infraorbital+ Infratrochlear Nerve Block on Perioperative Remifentanil Consumption and Postoperative Pain Scores for Rhinoplasty Operations

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local
• Intervention / Treatment: Other: bilateral infraorbital+infratrochlear block

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Istanbul University, Department of anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Patients undergoing rhinoplasty surgery

Exclusion Criteria:

• Bleeding disorder
• Patient refusal
• Age under 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bilateral infraorbital+infratrochlear block group; For this group we will perform bilateral infraorbital+infratrochlear block before surgery	Other: bilateral infraorbital+infratrochlear block; we will perform bilateral infraorbital+infratrochlear nerve block
No Intervention: non-block group; For this group we will start the surgery without performing a block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remifentanil consumption	We will compare the remifentanil consumption for the block performed and non-block group	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical bleeding grading	We will compare the surgical bleeding scores for the block performed and non-block group	6 hours
Post-operative nausea and vomiting	We will compare the Post-operative nausea and vomiting for the block performed and non-block group	6 hours
Need for analgesic after surgery	We will compare the Need for analgesic after surgery for the block performed and non-block group	6 hours
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	6 hours
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"	6 hours

Collaborators and Investigators

• Sponsor: Istanbul University

Publications and helpful links

General 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2022
• Primary Completion (Actual): February 15, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: January 1, 2023
• First Submitted That Met QC Criteria: January 1, 2023
• First Posted (Actual): January 4, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022/1852

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No