Postoperative PainNCT03731468
Ultrasound Guided Intermediate Cervical Plexus Block in Thyroid Surgery
A study testing local anesthetic and Dexamethasone in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
studying the effect of dexmeditomidine addition to bupivacaine in bilateral intermediate cervical block for patients undergoing thyroidectomy under general anaesthesia Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- local anesthetic and Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2018to 1 Dec 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Elective surgery
- ASA 1, II, AND III
Who cannot join
- Patient refusal
- Infection at the entry site
- BMI > 3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dexmethasone Addition to Bupivacaine in Bilateral Intermediate Cervical Block in Thyroid Surgery
studying the effect of dexmeditomidine addition to bupivacaine in bilateral intermediate cervical block for patients undergoing thyroidectomy under general anaesthesia
Read the detailed description
80 patients who will be undergoing elective thyroidectomy will be randomly allocated into one of two groups ; group A will receive 20 mg isobaric bupivacaine + 8 mg dexamethasone(diluted in 5 ml) group B will receive 20 mg isobaric bupivacaine + 1 ml normal saline. block will be done under complete a septic condition after induction of general anaesthesia.
- Conditions
- Postoperative Pain
- Being tested
- local anesthetic, Dexamethasone
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local anestheticDrug
ultrasound guided superficial cervical block in thyroid surgery
DexamethasoneDrug
dexamethasone will be added to ultrasound guided superficial cervical block in thyroid surgery
| Study group | Role | What they receive |
|---|---|---|
| dexmethasone group | Active comparator | 8 mg dexamethasone will be added to local anaesthetics Receives: Drug: Dexamethasone |
| control group | Sham comparator | isobaric bupivacaine will be given on each side Receives: Drug: local anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative analgesia duration
time of first analgesic requirement is the time of end of block analgesia
Measured: 24 hour postoperative
Secondary outcomes (1)
postoperative complications related to the block
occurrence of complications secondary to the block well be recorded
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start15 Sep 2018
- Primary completion1 Jan 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Hamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731468
- Sponsor's protocol ID
- UDLC
- Status last verified
- Mar 2021
- First submitted
- 9 Jul 2018
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmethasone Addition to Bupivacaine in Bilateral Intermediate Cervical Block in Thyroid Surgery
- ClinicalTrials.gov ID
- NCT03731468
- Acronym / sponsor ID
- UDLC
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 6 Nov 2018 (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.
studying the effect of dexmeditomidine addition to bupivacaine in bilateral intermediate cervical block for patients undergoing thyroidectomy under general anaesthesia
Detailed description
80 patients who will be undergoing elective thyroidectomy will be randomly allocated into one of two groups ; group A will receive 20 mg isobaric bupivacaine + 8 mg dexamethasone(diluted in 5 ml) group B will receive 20 mg isobaric bupivacaine + 1 ml normal saline. block will be done under complete a septic condition after induction of general anaesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmethasone group | Active comparator | Drug: Dexamethasone8 mg dexamethasone will be added to local anaesthetics |
| control group | Sham comparator | Drug: local anestheticisobaric bupivacaine will be given on each side |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Elective surgery
- ASA 1, II, AND III
Key exclusion criteria (3 listed)
- Patient refusal
- Infection at the entry site
- BMI > 3
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 |
|---|---|---|
| local anestheticultrasound guided superficial cervical block in thyroid surgery | Drug | control group |
| Dexamethasonedexamethasone will be added to ultrasound guided superficial cervical block in thyroid surgery | Drug | dexmethasone group |
Primary outcome
postoperative analgesia duration
Time frame: 24 hour postoperative
time of first analgesic requirement is the time of end of block analgesia
1 secondary outcome
postoperative complications related to the block
Time frame: 8 hours
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 10 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local anesthetic and Dexamethasone in people with Postoperative Pain, 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 2 inclusion and 3 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 10 Mar 2021. 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. Some participants in this study may receive a placebo. 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?
postoperative analgesia duration (time frame: 24 hour 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 10 Mar 2021.