Pain ManagementNCT03277599
Comparison of Two Pain-treatment Techniques After Tympanomastoid Surgery Pain
A study testing ultrasound guided superficial cervical plexus block and ultrasound guided Great Auricular nerve block in people with Pain Management and Nerve Block, run by Bursa Yuksek Ihtisas Training and Research Hospital.
Trial summary
Analgesia following tympanomastoid surgery is critical for the prevention of postoperative . There are very few regional anesthesia methods used to achieve this goal. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pain Management, Nerve Block, Ultrasound
- What is being tested?
- ultrasound guided superficial cervical plexus block and ultrasound guided Great Auricular nerve block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2016to 7 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent Tympanomastoid surgery.
Who cannot join
- Previous history of opioid use preoperatively,
- Allergy to local anesthetics,
- The presence of any systemic infection,
- Uncontrolled arterial hypertension,
- Uncontrolled diabetes mellitus.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain Management, Nerve Block, Ultrasound
- Being tested
- IV patient-controlled analgesia (PCA) tramadol, ultrasound guided superficial cervical plexus block, ultrasound guided Great Auricular nerve block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV patient-controlled analgesia (PCA) tramadolDrug
Also called 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.
ultrasound guided superficial cervical plexus blockDrug
Also called superficial cervical plexus block
ultrasound guided superficial cervical plexus blockage with 10 ml % 0.25 bupivacaine
ultrasound guided Great Auricular nerve blockDrug
Also called Great Auricular nerve block
ultrasound guided Great Auricular nerve blockage with 5 ml % 0.25 bupivacaine +IV patient-controlled analgesia (PCA) tramadol
| Study group | Role | What they receive |
|---|---|---|
| Grup Y | Active comparator | ultrasound guided superficial cervical plexus blockage with 10 ml % 0.25 bupivacaine+IV patient-controlled analgesia (PCA) tramadol Receives: Drug: IV patient-controlled analgesia (PCA) tramadol; Drug: ultrasound guided superficial cervical plexus block |
| Grup B | Active comparator | ultrasound ultrasound guided Great Auricular nerve blockage with 5 ml % 0.25 bupivacaine +IV patient-controlled analgesia (PCA) tramadol Receives: Drug: IV patient-controlled analgesia (PCA) tramadol; Drug: ultrasound guided Great Auricular nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Pain Scale
Visual Analog Pain Scale was used for pain
Measured: Postoperative 24 hours
Secondary outcomes (3)
tramadol consumption
tramadol consumption
Measured: Postoperative 24 hour
side effect profile
side effect profile (including nausea and vomiting, hypotension,requirement and the Ramsay Sedation Scale (RSS) scores)
Measured: Postoperative 24 hour
additional analgesic use
additional analgesic use
Measured: Postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start5 Jul 2016
- Primary completion5 Dec 2016
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective,randomized,single blind
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Korgün Ökmen, M.D, Principal investigator, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277599
- Sponsor's protocol ID
- 2011-KAEK-25 2016/21-02
- Status last verified
- Mar 2018
- First submitted
- 17 Jul 2017
- Last updated
- 20 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Superficial Cervical Plexus Block Versus Greater Auricular Nerve Block for Tympanomastoid Surgery Pain
- ClinicalTrials.gov ID
- NCT03277599
- Acronym / sponsor ID
- 2011-KAEK-25 2016/21-02
- Conditions
- Pain Management, Nerve Block, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 5 Jul 2016 (actual)
- Primary completion
- 5 Dec 2016 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective,randomized,single blind
| Arm | Type | Receives |
|---|---|---|
| Grup Y | Active comparator | Drug: IV patient-controlled analgesia (PCA) tramadol, Drug: ultrasound guided superficial cervical plexus blockultrasound guided superficial cervical plexus blockage with 10 ml % 0.25 bupivacaine+IV patient-controlled analgesia (PCA) tramadol |
| Grup B | Active comparator | Drug: IV patient-controlled analgesia (PCA) tramadol, Drug: ultrasound guided Great Auricular nerve blockultrasound ultrasound guided Great Auricular nerve blockage with 5 ml % 0.25 bupivacaine +IV patient-controlled analgesia (PCA) tramadol |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent Tympanomastoid surgery.
Key exclusion criteria (5 listed)
- Previous history of opioid use preoperatively,
- Allergy to local anesthetics,
- The presence of any systemic infection,
- Uncontrolled arterial hypertension,
- Uncontrolled diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV patient-controlled analgesia (PCA) tramadolAlso: TramadolTramadol 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. | Drug | Grup B, Grup Y |
| ultrasound guided superficial cervical plexus blockAlso: superficial cervical plexus blockultrasound guided superficial cervical plexus blockage with 10 ml % 0.25 bupivacaine | Drug | Grup Y |
| ultrasound guided Great Auricular nerve blockAlso: Great Auricular nerve blockultrasound guided Great Auricular nerve blockage with 5 ml % 0.25 bupivacaine +IV patient-controlled analgesia (PCA) tramadol | Drug | Grup B |
Primary outcome
Visual Analog Pain Scale
Time frame: Postoperative 24 hours
Visual Analog Pain Scale was used for pain
3 secondary outcomes
tramadol consumption
Time frame: Postoperative 24 hour
side effect profile
Time frame: Postoperative 24 hour
additional analgesic use
Time frame: Postoperative 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Korgün Ökmen, M.D principal investigator
University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospita
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided superficial cervical plexus block and ultrasound guided Great Auricular nerve block in people with Pain Management and Nerve Block, run by Bursa Yuksek Ihtisas Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Pain Scale (time frame: Postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.