Thyroid CancerNCT01325857
Analgesic Efficacy of Bilateral Superficial Cervical Plexus Block in Robot-assisted Endoscopic Thyroidectomy Using a Transaxillary Approach
A study testing Bilateral superficial cervical plexus block in people with Thyroid Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
This study was designed to investigate the analgesic effect of bilateral superficial cervical plexus block in patients undergoing robot-assisted endoscopic thyroidectomy. The investigators hypothesized that bilateral superficial cervical plexus blockade would reduce the patient's pain score by more than 10 (on a VAS… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Bilateral superficial cervical plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Feb 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class 1 or 2 adult patients scheduled for robot-assisted endoscopic thyroidectomy
Who cannot join
- Patient refusal
- Bleeding diathesis
- Allergies to local anesthetics
- Patient unable to read consent form (Foreigner, illiterate)
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
This study was designed to investigate the analgesic effect of bilateral superficial cervical plexus block in patients undergoing robot-assisted endoscopic thyroidectomy. The investigators hypothesized that bilateral superficial cervical plexus blockade would reduce the patient's pain score by more than 10 (on a VAS scale of 0~100) compared to a placebo group and control group.
- Conditions
- Thyroid Cancer
- Being tested
- Bilateral superficial cervical plexus block, placebo, Control group
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral superficial cervical plexus blockProcedure or surgery
Bilateral superficial cervical plexus block with 0.525% ropivacaine 20ml
placeboProcedure or surgery
Procedure: Bilateral superficial cervical plexus block with normal saline 20ml
Control groupProcedure or surgery
Procedure: Local anesthetic infiltration at incision site with 0.525% ropivacaine 20ml
| Study group | Role | What they receive |
|---|---|---|
| Group B | Experimental | Group B = Nerve block group Receives: Procedure: Bilateral superficial cervical plexus block |
| Group L | Placebo comparator | Group L = Local wound infiltration group Receives: Procedure: placebo |
| Group C | Active comparator | Group C = Control group Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue pain score
Measured: Immediate post-operation (at recovery room) (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325857
- Sponsor's protocol ID
- 4-2010-0668
- Status last verified
- Feb 2012
- First submitted
- 28 Mar 2011
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Shin S, Chung WY, Jeong JJ, Kang SW, Oh YJ. Analgesic efficacy of bilateral superficial cervical plexus block in robot-assisted endoscopic thyroidectomy using a transaxillary approach. World J Surg. 2012 Dec;36(12):2831-7. doi: 10.1007/s00268-012-1780-0.
PubMed 22956016
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Bilateral Superficial Cervical Plexus Block in Robot-assisted Endoscopic Thyroidectomy Using a Transaxillary Approach
- ClinicalTrials.gov ID
- NCT01325857
- Acronym / sponsor ID
- 4-2010-0668
- Conditions
- Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 30 Mar 2011 (estimated)
- 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.
This study was designed to investigate the analgesic effect of bilateral superficial cervical plexus block in patients undergoing robot-assisted endoscopic thyroidectomy. The investigators hypothesized that bilateral superficial cervical plexus blockade would reduce the patient's pain score by more than 10 (on a VAS scale of 0~100) compared to a placebo group and control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group B | Experimental | Procedure: Bilateral superficial cervical plexus blockGroup B = Nerve block group |
| Group L | Placebo comparator | Procedure: placeboGroup L = Local wound infiltration group |
| Group C | Active comparator | Procedure: Control groupGroup C = Control group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA class 1 or 2 adult patients scheduled for robot-assisted endoscopic thyroidectomy
Key exclusion criteria (5 listed)
- Patient refusal
- Bleeding diathesis
- Allergies to local anesthetics
- Patient unable to read consent form (Foreigner, illiterate)
- Pregnant women
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 |
|---|---|---|
| Bilateral superficial cervical plexus blockBilateral superficial cervical plexus block with 0.525% ropivacaine 20ml | Procedure or surgery | Group B |
| placeboProcedure: Bilateral superficial cervical plexus block with normal saline 20ml | Procedure or surgery | Group L |
| Control groupProcedure: Local anesthetic infiltration at incision site with 0.525% ropivacaine 20ml | Procedure or surgery | Group C |
Primary outcome
Visual analogue pain score
Time frame: Immediate post-operation (at recovery room) (day 1)
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 28 Feb 2012.
- Derived from this study: PubMed 22956016Shin S, Chung WY, Jeong JJ, Kang SW, Oh YJ. Analgesic efficacy of bilateral superficial cervical plexus block in robot-assisted endoscopic thyroidectomy using a transaxillary approach. World J Surg. 2012 Dec;36(12):2831-7. doi: 10.1007/s00268-012-1780-0.
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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 Bilateral superficial cervical plexus block in people with Thyroid Cancer, run by Yonsei University at 1 site in South Korea.
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 28 Feb 2012. 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 South Korea. 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?
Visual analogue pain score (time frame: Immediate post-operation (at recovery room) (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01325857, which also lists 1 linked publication.
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 28 Feb 2012.