Evaluation of Postoperative Pain Control in Ear Surgery

NCT06869967 | Recruiting

• 1 other identifier: 2024-KAEK-11
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia; Post Operative Pain

Keywords

Regional Anesthesia; Ear Surgery; Auricularis Magnus Nerve Block

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  Intraoperative opioid consumption

  During the operation

Secondary Outcomes (2)

• Morphine consumption

  1 hours after surgery(T1), 6 hours after surgery (T2), 12 hours after surgery (T3), 24 hours after surgery (T4)

• NRS Scores

  1 hours after surgery(T1), 6 hours after surgery (T2), 12 hours after surgery (T3), 24 hours after surgery (T4)

Study Arms (2)

Auricularis Magnus Nerve Block

ACTIVE COMPARATOR

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

Procedure: Auricularis Magnus Nerve Block

Control

ACTIVE COMPARATOR

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.

Procedure: Control Group

Interventions

Auricularis Magnus Nerve Block PROCEDURE

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

Auricularis Magnus Nerve Block

Control Group PROCEDURE

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

Control

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead
• Başakşehir Çam & Sakura City Hospital: collaborator

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, 34480, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Nur Nazire YUCAL, MD

CONTACT

05443898086; n_395@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): July 15, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

TU (1)