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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05671237
Other study ID # 2022/1852
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 11, 2022
Est. completion date March 1, 2023

Study information

Verified date June 2023
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 1, 2023
Est. primary completion date February 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Patients undergoing rhinoplasty surgery Exclusion Criteria: - Bleeding disorder - Patient refusal - Age under 18

Study Design


Related Conditions & MeSH terms


Intervention

Other:
bilateral infraorbital+infratrochlear block
we will perform bilateral infraorbital+infratrochlear nerve block

Locations

Country Name City State
Turkey Istanbul University, Department of Anesthesiology Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Remifentanil consumption We will compare the remifentanil consumption for the block performed and non-block group 6 hours
Secondary Surgical bleeding grading We will compare the surgical bleeding scores for the block performed and non-block group 6 hours
Secondary 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
Secondary 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
Secondary Post-operative nausea and vomiting We will compare the Post-operative nausea and vomiting for the block performed and non-block group 6 hours
Secondary Need for analgesic after surgery We will compare the Need for analgesic after surgery for the block performed and non-block group 6 hours
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