Evaluation of Postoperative Pain Control in Ear Surgery

March 9, 2026 updated by: Nur Nazire Yucal, Kocaeli University

Evaluation of Ultrasound-Guided Auricularis Magnus Nerve Block for Postoperative Pain Control in Ear Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34480
        • Recruiting
        • Başakşehir Çam and Sakura City Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Auricularis Magnus Nerve Block
Auricularis Magnus Nerve block will be performed using 5 mL of %0.5 bupivacaine
Active Comparator: 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.
Procedure: Control Group
Intravenous analgesics 1 gram paracetamol, 20 mg tenoxicam, 8 mg ondansetron will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: During the operation
Intraoperative opioid consumption
During the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption
Time Frame: 1 hours after surgery(T1), 6 hours after surgery (T2), 12 hours after surgery (T3), 24 hours after surgery (T4)
Postoperative morphine consumption
1 hours after surgery(T1), 6 hours after surgery (T2), 12 hours after surgery (T3), 24 hours after surgery (T4)
NRS Scores
Time Frame: 1 hours after surgery(T1), 6 hours after surgery (T2), 12 hours after surgery (T3), 24 hours after surgery (T4)
NRS scores of the patients after the surgery (0=no pain, 10=worst pain imaginable)
1 hours after surgery(T1), 6 hours after surgery (T2), 12 hours after surgery (T3), 24 hours after surgery (T4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Collaborators

Başakşehir Çam & Sakura City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2025

Primary Completion (Estimated)

May 25, 2026

Study Completion (Estimated)

July 15, 2026

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 11, 2025

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-KAEK-11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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