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RecruitingNCT06869967Updated Aug 5, 2026

Evaluation of Postoperative Pain Control in Ear Surgery

An interventional study of Auricularis Magnus Nerve Block and Control Group in Post Operative Pain and Analgesia, sponsored by Kocaeli University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by Kocaeli University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Post Operative Pain
  • Analgesia

Keywords

  • Regional Anesthesia
  • Ear Surgery
  • Auricularis Magnus Nerve Block
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
56 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureAuricularis Magnus Nerve Block

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

  • ProcedureControl Group

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

05

What researchers measure

Primary outcomes

  1. Opioid consumption

    Intraoperative opioid consumption

    Time frame: During the operation

Secondary outcomes

  1. Morphine consumption

    Postoperative morphine consumption

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

  2. NRS Scores

    NRS scores of the patients after the surgery (0=no pain, 10=worst pain imaginable)

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

06

Study locations

1 of 1 sites recruiting
  • Başakşehir Çam and Sakura City Hospital
    Istanbul, 34480, Turkey (Türkiye)
    Recruiting
07

Registry details

Key details

Study ID
NCT06869967
Lead sponsor
Kocaeli University
Collaborators
Başakşehir Çam & Sakura City Hospital
Responsible party
Nur Nazire Yucal (Doctor, Başakşehir Çam & Sakura City Hospital) — Principal investigator
First posted
Mar 11, 2025
Start date
Oct 20, 2025
Primary completion
Nov 25, 2026 (estimated)
Completion
Feb 15, 2027 (estimated)
Last update
Aug 5, 2026

Study contacts

Nur Nazire YUCAL, MD
Contact
n_395@hotmail.com
05443898086

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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