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NCT Number: NCT06869967

Evaluation of 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Başakşehir Çam and Sakura City Hospital

Istanbul, 34480, Turkey (Türkiye)

Location status: Recruiting

Location contact

Nur Nazire YUCAL, MD

CONTACT

[email protected]

05443898086

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auricularis Magnus Nerve Block

Procedure

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

Control Group

Procedure

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

Primary outcomes

  1. Opioid consumption

    Time frame: During the operation

    Intraoperative opioid consumption

Secondary outcomes

  1. 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

  2. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Nur Nazire YUCAL, MD

CONTACT

[email protected]

05443898086

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Collaborators

  • Başakşehir Çam & Sakura City Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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