Post Operative PainNCT06869967
Evaluation of Postoperative Pain Control in Ear Surgery
A study testing Auricularis Magnus Nerve Block in people with Post Operative Pain and Analgesia, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain, Analgesia
- What is being tested?
- Auricularis Magnus Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2025to 15 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Başakşehir Çam and Sakura City Hospital
Istanbul, 34480
Nur Nazire YUCAL, MD, 05443898086, n_395@hotmail.com
About this study
Official title: Evaluation of Ultrasound-Guided Auricularis Magnus Nerve Block for 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.
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.
- Conditions
- Post Operative Pain, Analgesia
- Being tested
- Auricularis Magnus Nerve Block, Control Group
- Keywords
- Regional Anesthesia, Ear Surgery, Auricularis Magnus Nerve Block
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricularis Magnus Nerve BlockProcedure or surgery
Auricularis Magnus Nerve block will be performed using 5 mL of %0.5 bupivacaine
Control GroupProcedure or surgery
Intravenous analgesics 1 gram paracetamol, 20 mg tenoxicam, 8 mg ondansetron will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Auricularis Magnus Nerve Block | Active comparator | Ultrasound (US) -guided Auricularis Magnus Nerve Block with 5 ml 0.5 % bupivacaine will performe preoperatively to all patients in the AMG group. Receives: Procedure: Auricularis Magnus Nerve Block |
| Control | Active comparator | 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. Receives: Procedure: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Intraoperative opioid consumption
Measured: During the operation
Secondary outcomes (2)
Morphine consumption
Postoperative morphine consumption
Measured: 1 hours after surgery(T1), 6 hours after surgery (T2), 12 hours after surgery (T3), 24 hours after surgery (T4)
NRS Scores
NRS scores of the patients after the surgery (0=no pain, 10=worst pain imaginable)
Measured: 1 hours after surgery(T1), 6 hours after surgery (T2), 12 hours after surgery (T3), 24 hours after surgery (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start20 Oct 2025
- Primary completion25 Nov 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Collaborators
- Başakşehir Çam & Sakura City Hospital
- Responsible party
- Principal investigator, Nur Nazire Yucal, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869967
- Sponsor's protocol ID
- 2024-KAEK-11
- Status last verified
- Aug 2026
- First submitted
- 5 Mar 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No