Evaluation of Postoperative Pain Control in Ear Surgery

Not Applicable

Not yet recruiting

• Conditions: Post Operative Pain; Analgesia

• Registration Number: NCT06869967
• Lead Sponsor: Kocaeli University

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.

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 Timeline

• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-05
• Study First Posted: 2025-03-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Study Start: 2025-06-15
• Primary Completion: 2025-10-15
• Study Completion: 2025-11-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Opioid consumption	During the operation	Intraoperative opioid consumption

Secondary Outcome Measures

Name	Time	Method
Morphine consumption	1 hours after surgery(T1), 6 hours after surgery (T2), 12 hours after surgery (T3), 24 hours after surgery (T4)	Postoperative morphine consumption
NRS Scores	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)

Trial Locations

Locations (1)

Başakşehir Çam and Sakura City Hospital; 🇹🇷 Istanbul, Turkey