Effect of Maxillary Nerve Block for Septoplasty

The aim of this study was to determine the effect of maxillary nerve blockage on both postoperative pain scores and recovery quality index in septoplasty operations. Thus, it was aimed to determine an alternative method that can be used in postoperative analgesia that will suppress postoperative pain complaints and increase the comfort level of patients after septoplasty operations.

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain
• Intervention / Treatment: Procedure: Maxillary nerve block

Detailed Description

Patients who were planned to be operated for septoplasty at Adıyaman University Training and Research Hospital, who were informed about the study and agreed to participate in the study with their written consent were included in the study.

The patients who agreed to participate in the study were divided into two groups by closed envelope method and bilateral maxillary nerve blockade was planned to be performed using 10 cc 0.25% bupivacaine via suprazigomatic approach after providing airway safety in the block group with general anaesthesia applications in both groups. The haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), postoperative numeric pain scores and postoperative quality of recovery index (QoR-15) values at the 24th hour were recorded and these values were compared in both groups.

Thus, it was aimed to evaluate the effects of maxillary nerve blockade in septoplasty operations.

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

Contacts and Locations

• Study Contact: Name: Nezir Yılmaz; Phone Number: 05068939496; Email: yilmaznezirr@gmail.com

Study Locations

• Turkey
  • Adıyaman, Turkey, 02200
    • Recruiting
    • Adıyaman Training and Research Hospital
    • Contact: Nezir YILMAZ, Dr; Phone Number: +905068939496; Email: yilmaznezir@hotmail.com
    • Principal Investigator: Nezir YILMAZ, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA I-II , Septoplasty patints

Exclusion Criteria:

• ASA III-IV
• Deny to participte in study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Block group; Bilateral maxillary nerve block was planned to be performed using 10 cc 0.25% bupivacaine via suprazigomatic approach after providing airway safety in the block group with general anaesthesia applications. The haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), postoperative numeric pain scores and postoperative quality of recovery index (QoR-15) values at the 24th hour will be recorded .	Procedure: Maxillary nerve block; It is aimed to reach the maxillary nerve trace with a peripheral nerve block needle using the suprazigomatic approach and to create a temporary block in the maxillary nerve with local anaesthetic injection.
No Intervention: Control group; No intevention was planned for this group. Only genaeral anesthesia applications will use for surgery. The haemodynamic values (blood pressure arterial, peak heart rate, peripheral oxygen saturation), postoperative numeric pain scores and postoperative quality of recovery index (QoR-15) values at the 24th hour will be recorded .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The visual analog pain score	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of recovery (QoR -15)	The QoR-15 scale is a unidimensional measurement of quality of recovery measured in five domains: physical comfort, pain, physical independence, psychological support, and emotional state. The QoR-15 scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery	three months

Collaborators and Investigators

• Sponsor: Adiyaman University Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): September 15, 2024

Study Registration Dates

• First Submitted: May 11, 2024
• First Submitted That Met QC Criteria: May 11, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: postoperative pain; septoplasty; maxillary nerve block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: ADYU-ANS-NY-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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