- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03277599
Comparison of Two Pain-treatment Techniques After Tympanomastoid Surgery Pain
March 19, 2018 updated by: Korgün Ökmen, Bursa Yüksek İhtisas Education and Research Hospital
Ultrasound Guided Superficial Cervical Plexus Block Versus Greater Auricular Nerve Block for Tympanomastoid Surgery Pain
Analgesia following tympanomastoid surgery is critical for the prevention of postoperative .
There are very few regional anesthesia methods used to achieve this goal.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Grup Y
ultrasound guided superficial cervical plexus blockage with 10 ml % 0.25 bupivacaine+IV patient-controlled analgesia (PCA) tramadol
|
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.
Other Names:
ultrasound guided superficial cervical plexus blockage with 10 ml % 0.25 bupivacaine
Other Names:
|
ACTIVE_COMPARATOR: Grup B
ultrasound ultrasound guided Great Auricular nerve blockage with 5 ml % 0.25 bupivacaine +IV patient-controlled analgesia (PCA) tramadol
|
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.
Other Names:
ultrasound guided Great Auricular nerve blockage with 5 ml % 0.25 bupivacaine +IV patient-controlled analgesia (PCA) tramadol
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Pain Scale
Time Frame: Postoperative 24 hours
|
Visual Analog Pain Scale was used for pain
|
Postoperative 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tramadol consumption
Time Frame: Postoperative 24 hour
|
tramadol consumption
|
Postoperative 24 hour
|
side effect profile
Time Frame: Postoperative 24 hour
|
side effect profile (including nausea and vomiting, hypotension,requirement and the Ramsay Sedation Scale (RSS) scores)
|
Postoperative 24 hour
|
additional analgesic use
Time Frame: Postoperative 24 hour
|
additional analgesic use
|
Postoperative 24 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Korgün Ökmen, M.D, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospita
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 5, 2016
Primary Completion (ACTUAL)
December 5, 2016
Study Completion (ACTUAL)
July 7, 2017
Study Registration Dates
First Submitted
July 17, 2017
First Submitted That Met QC Criteria
September 7, 2017
First Posted (ACTUAL)
September 11, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 20, 2018
Last Update Submitted That Met QC Criteria
March 19, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-KAEK-25 2016/21-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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