Effect of Maxillary Nerve Block for Septoplasty

NCT06417723 | Recruiting

• 1 other identifier: ADYU-ANS-NY-04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Pain

Keywords

postoperative pain; maxillary nerve block; septoplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of recovery (QoR -15)

  three months

Study Arms (2)

Block group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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 .

Interventions

Maxillary nerve block PROCEDURE

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.

Block group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II , Septoplasty patints

You may not qualify if:

• ASA III-IV
• Deny to participte in study

Sponsors & Collaborators

• Adiyaman University Research Hospital: lead

Study Sites (1)

Adıyaman Training and Research Hospital

Adıyaman, 02200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Nezir Yılmaz

CONTACT

05068939496; yilmaznezirr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: for patients - closed envelope system for investigator - Maxillary nerve block performer will not participate pain and results assesment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor,MD

Model Details: two groups designed from septoplasty patintes for study. 1. only general anesthesia 2. General anesthesia + maxillary nerve block

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: May 16, 2024
• Study Start: June 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: September 15, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-05

Locations

TU (1)