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Recruiting NCT06869967

Evaluation of Postoperative Pain Control in Ear Surgery

No phase Interventional Post Operative Pain Analgesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Auricularis Magnus Nerve Block, Control Group.
Who it may be relevant to
Registry conditions: Post Operative Pain, Analgesia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • Procedure Auricularis Magnus Nerve Block
    Auricularis Magnus Nerve block will be performed using 5 mL of %0.5 bupivacaine
  • Procedure Control Group
    Intravenous analgesics 1 gram paracetamol, 20 mg tenoxicam, 8 mg ondansetron will be administered.

Primary outcome measures

  • Opioid consumption [Time frame: During the operation]
Secondary outcome measures (2)
  • Morphine consumption [Time frame: 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Turkey (Türkiye) · 1 center
  • Başakşehir Çam and Sakura City Hospital — Istanbul

Identifiers

NCT: NCT06869967 · 2024-KAEK-11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗