Evaluation of Postoperative Pain Control in Ear Surgery

NCT ID: NCT06869967

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-20

Study Completion Date

2026-02-15

Brief Summary

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Middle ear surgery is the most popular procedure in ear, nose and throat surgery. Increased sympathetic stimulation after surgery can activate the sympathetic system, causing hypertension and increased heart rate. As a result of these clinical conditions, hemorrhage can occur, which can impair the quality of the surgical field, which is undesirable in middle ear surgery.Clinical studies should be conducted with auricularis magnus nerve block applied in the perioperative period in middle ear surgery and postoperative pain scores.

Detailed Description

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Middle ear surgery is the most popular procedure in ear, nose and throat surgery. Increased sympathetic stimulation after surgery can activate the sympathetic system, causing hypertension and increased heart rate. As a result of these clinical conditions, hemorrhage can occur, which can impair the quality of the surgical field, which is undesirable in middle ear surgery.Ultrasound-guided auricularis magnus nerve block can be used as a potential solution to these problems. Ultrasound-guided peripheral nerve block can be visualized. It is appropriate and applicable to block a single distal nerve with a small dose of local anesthetic under ultrasound guidance. Ultrasound-guided blocking of the blocked area has reduced side effects with increased accuracy and accurate analgesic effect.

In middle ear microsurgery, the nerve innervation of the postauricular incision area may not primarily originate from the auricularis magnus. Therefore, clinical studies should be conducted with auricularis magnus nerve block applied in the perioperative period in middle ear surgery and postoperative pain scores.

Conditions

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Post Operative Pain Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Auricularis Magnus Nerve Block

Ultrasound (US) -guided Auricularis Magnus Nerve Block with 5 ml 0.5 % bupivacaine will performe preoperatively to all patients in the AMG group.

Group Type ACTIVE_COMPARATOR

Auricularis Magnus Nerve Block

Intervention Type PROCEDURE

Auricularis Magnus Nerve block will be performed using 5 mL of %0.5 bupivacaine

Control

In the control group, patients will be administered intravenous analgesics of 1 gram paracetamol, 20 mg tenoxicam, and 8 mg ondansetron 30 minutes before the end of the operation, as stated in the patient protocol, during their follow-up after general anesthesia.

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type PROCEDURE

Intravenous analgesics 1 gram paracetamol, 20 mg tenoxicam, 8 mg ondansetron will be administered.

Interventions

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Auricularis Magnus Nerve Block

Auricularis Magnus Nerve block will be performed using 5 mL of %0.5 bupivacaine

Intervention Type PROCEDURE

Control Group

Intravenous analgesics 1 gram paracetamol, 20 mg tenoxicam, 8 mg ondansetron will be administered.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing CWD and Mastodectom
* Patients undergoing elective surgery
* ASA (American Society of Anesthesiologists) physical status classification I-II
* Patients over 18 years of age

Exclusion Criteria

* Anticoagulant use
* Allergy to the drugs to be used
* ASA (American Society of Anesthesiologists) physical status classification IV-V
* Presence of infection in the area where the block will be applied
* Patient's refusal to accept the block application or inability to cooperate with the patient
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role collaborator

Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Nur Nazire Yucal

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Başakşehir Çam and Sakura City Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Nur Nazire YUCAL, MD

Role: CONTACT

05443898086

Facility Contacts

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Nur Nazire YUCAL, MD

Role: primary

05443898086

Other Identifiers

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2024-KAEK-11

Identifier Type: -

Identifier Source: org_study_id

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