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

Sponsor
Istanbul University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05671237
Collaborator
(none)
60
1
2
3.6
16.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: bilateral infraorbital+infratrochlear block
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
The Effect of Bilateral Infraorbital+ Infratrochlear Nerve Block on Perioperative Remifentanil Consumption and Postoperative Pain Scores for Rhinoplasty Operations
Actual Study Start Date :
Nov 11, 2022
Anticipated Primary Completion Date :
Feb 15, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Remifentanil consumption [6 hours]

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

Secondary Outcome Measures

  1. Surgical bleeding grading [6 hours]

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

  2. Richmond agitation sedation scale [6 hours]

    We will compare the Richmond agitation sedation scale for the block performed and non-block group

  3. Numeric rating Scale [6 hours]

    We will compare the numeric rating scale for pain for the block performed and non-block group

  4. Post-operative nausea and vomiting [6 hours]

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

  5. Need for analgesic after surgery [6 hours]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Patients undergoing rhinoplasty surgery

Exclusion Criteria:
  • Bleeding disorder

  • Patient refusal

  • Age under 18

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University, Department of Anesthesiology Istanbul Turkey 34093

Sponsors and Collaborators

  • Istanbul University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Reyhan Nil Kırsan, Principal Investigator, Istanbul University
ClinicalTrials.gov Identifier:
NCT05671237
Other Study ID Numbers:
  • 2022/1852
First Posted:
Jan 4, 2023
Last Update Posted:
Jan 4, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 4, 2023