Comparison of Two Pain-treatment Techniques After Tympanomastoid Surgery Pain

Study Overview
=================
Brief Summary
-----------------
Analgesia following tympanomastoid surgery is critical for the prevention of postoperative . There are very few regional anesthesia methods used to achieve this goal.

Detailed Description
-----------------
In this study, it was aimed to investigate the effect of Ultrasound guided superficial cervical plexus block versus greater auricular nerve block for on postoperative tympanomastoid surgery analgesia.

Official Title
-----------------
Ultrasound Guided Superficial Cervical Plexus Block Versus Greater Auricular Nerve Block for Tympanomastoid Surgery Pain

Conditions
-----------------
Pain Management, Nerve Block, Ultrasound

Intervention / Treatment
-----------------
* Drug: IV patient-controlled analgesia (PCA) tramadol
* Drug: ultrasound guided superficial cervical plexus block
* Drug: ultrasound guided Great Auricular nerve block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent Tympanomastoid surgery. Exclusion Criteria: Previous history of opioid use preoperatively, Allergy to local anesthetics, The presence of any systemic infection, Uncontrolled arterial hypertension, Uncontrolled diabetes mellitus.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective,randomized,single blind
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Grup Y<br>ultrasound guided superficial cervical plexus blockage with 10 ml % 0.25 bupivacaine+IV patient-controlled analgesia (PCA) tramadol | Drug: IV patient-controlled analgesia (PCA) tramadol<br>* Tramadol infusion (PCA): 400 mg tramadol, IV 4 mg/mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.<br>* Other names: Tramadol;Drug: ultrasound guided superficial cervical plexus block<br>* ultrasound guided superficial cervical plexus blockage with 10 ml % 0.25 bupivacaine<br>* Other names: superficial cervical plexus block;|
| Active Comparator: Grup B<br>ultrasound ultrasound guided Great Auricular nerve blockage with 5 ml % 0.25 bupivacaine +IV patient-controlled analgesia (PCA) tramadol | Drug: IV patient-controlled analgesia (PCA) tramadol<br>* Tramadol infusion (PCA): 400 mg tramadol, IV 4 mg/mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.<br>* Other names: Tramadol;Drug: ultrasound guided Great Auricular nerve block<br>* ultrasound guided Great Auricular nerve blockage with 5 ml % 0.25 bupivacaine +IV patient-controlled analgesia (PCA) tramadol<br>* Other names: Great Auricular nerve block;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Pain Scale | Visual Analog Pain Scale was used for pain | Postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tramadol consumption | tramadol consumption | Postoperative 24 hour | 
| side effect profile | side effect profile (including nausea and vomiting, hypotension,requirement and the Ramsay Sedation Scale (RSS) scores) | Postoperative 24 hour | 
| additional analgesic use | additional analgesic use | Postoperative 24 hour |