Bilateral Superficial Cervical BlockNCT03109691
Ultrasound Guided Bilateral Superficial Cervical Block for Post-operative Pain Therapy in Thyroid Surgery
A study testing bupivacaine, Dexamethasone and ultrasound in people with Bilateral Superficial Cervical Block, run by Assiut University at 1 site in Egypt.
Trial summary
Ultrasound Guided Bilateral Superficial Cervical Block for Postoperative Pain Therapy in Thyroid Surgery Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Bilateral Superficial Cervical Block
- What is being tested?
- bupivacaine, Dexamethasone and ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jan 2018to Sep 2020
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) class I and II
Who cannot join
- allergy to local anesthetics, bleeding diatheses, and local infection or sepsis thyrotoxicosis and , malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexamethasone Effect Using Ultrasound Guided Bilateral Superficial Cervical Block for Postoperative Pain Therapy in Thyroid Surgery
Ultrasound Guided Bilateral Superficial Cervical Block for Postoperative Pain Therapy in Thyroid Surgery
- Conditions
- Bilateral Superficial Cervical Block
- Being tested
- bupivacaine, Dexamethasone, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaineDrug
group 1
DexamethasoneDrug
group 2
ultrasoundDevice
in all groups
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | 30 patients will receive bupivacaine Receives: Drug: bupivacaine; Drug: Dexamethasone; Device: ultrasound |
| group 2 | Active comparator | 30 patients will receive bupivacaine and Dexamethasone. . Receives: Drug: bupivacaine; Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
visual analoge scale (VAS)
Measured: through first 24 h postoperative.
Secondary outcomes (4)
HEART RATE
heart rate( beats per minute)
Measured: 5,10,15,30,60,90,120 min introperative
postoperative nausea, vomiting
postoperative nausea, vomiting was recorded
Measured: through first 24h postoperative
The time period for the first analgesic requirement
total dose
Measured: through first 24h postoperative
blood pressure
blood pressure (mm Hg)
Measured: 5,10,15,30,60,90,120 min intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start28 Jan 2018
- Primary completionJul 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Superficial Cervical BlockStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman A. Ismail, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109691
- Sponsor's protocol ID
- 01003060468
- Status last verified
- Jun 2019
- First submitted
- 30 Mar 2017
- Last updated
- 16 Mar 2020
- 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 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Effect Using Ultrasound Guided Bilateral Superficial Cervical Block for Postoperative Pain Therapy in Thyroid Surgery
- ClinicalTrials.gov ID
- NCT03109691
- Acronym / sponsor ID
- 01003060468
- Conditions
- Bilateral Superficial Cervical Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 28 Jan 2018 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 12 Apr 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.
Ultrasound Guided Bilateral Superficial Cervical Block for Postoperative Pain Therapy in Thyroid Surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Drug: bupivacaine, Drug: Dexamethasone, Device: ultrasound30 patients will receive bupivacaine |
| group 2 | Active comparator | Drug: bupivacaine, Device: ultrasound30 patients will receive bupivacaine and Dexamethasone. . |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) class I and II
Key exclusion criteria (1 listed)
- allergy to local anesthetics, bleeding diatheses, and local infection or sepsis thyrotoxicosis and , malignancy.
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 |
|---|---|---|
| bupivacainegroup 1 | Drug | group 1, group 2 |
| Dexamethasonegroup 2 | Drug | group 1 |
| ultrasoundin all groups | Device | group 1, group 2 |
Primary outcome
Visual Analog Scale
Time frame: through first 24 h postoperative.
visual analoge scale (VAS)
4 secondary outcomes
HEART RATE
Time frame: 5,10,15,30,60,90,120 min introperative
postoperative nausea, vomiting
Time frame: through first 24h postoperative
The time period for the first analgesic requirement
Time frame: through first 24h postoperative
blood pressure
Time frame: 5,10,15,30,60,90,120 min intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
Related trials for Bilateral Superficial Cervical Block
Enrolling by invitation
Comparison of Two Drugs Bupivacaine and Ropivacaine for Postoperative Analgesia in Bilateral Superficial Cervical Plexus Block After Thyroidectomy
Postoperative Pain
Active, not recruiting
ENDOblock: Bilateral Superficial Cervical Blocks With Local Wound Infiltration in Thyroid Surgery
Post Operative Pain, Nausea and Vomiting, Postoperative
Active, not recruitingPhase 4
Analgesic Effect of Superficial Cervical Plexus Block in Postoperative Neck Surgeries
Postoperative Pain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bupivacaine, Dexamethasone and ultrasound in people with Bilateral Superficial Cervical Block, run by Assiut University at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohmed Bakri, prof (+20882413201, mhbakri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: through first 24 h postoperative.). 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 16 Mar 2020.