Evaluation of Postoperative Pain Control in Ear Surgery

Kocaeli University

Status: Enrolling

Conditions: Analgesia; Post Operative Pain

Treatments: Procedure: Control Group; Procedure: Auricularis Magnus Nerve Block

Study type: Interventional

Funder types: Other

Identifiers

NCT06869967

2024-KAEK-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Auricularis Magnus Nerve Block

Active Comparator group

Description:

Ultrasound (US) -guided Auricularis Magnus Nerve Block with 5 ml 0.5 % bupivacaine will performe preoperatively to all patients in the AMG group.

Treatment:

Procedure: Auricularis Magnus Nerve Block

Control

Active Comparator group

Description:

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.

Treatment:

Procedure: Control Group