Thyroid CancerNCT01907997
Effects of Systemic Lidocaine on Postoperative Quality of Recovery After Robot-assisted Thyroidectomy
A study testing Systemic intravenous lidocaine infusion and normal saline infusion in people with Thyroid Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Systemic lidocaine infusion may improve the patients' recovery quality and chronic post surgical pain after robot-assisted thyroidectomy Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Systemic intravenous lidocaine infusion and normal saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to May 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20-65
- ASA class I and II
- Thyroid cancer patients who are scheduled for elective robot-assisted thyroidectomy
Who cannot join
- Allergy to local anesthetics or contraindication to use of lidocaine
- Pregnancy
- Severe cardiovascular disease
- Renal failure
- Liver failure
- Neurologic and psychologic disease
- Chronic treatment with analgesics
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei universiy college of medicine
Seoul, 120-752
About this study
Systemic lidocaine infusion may improve the patients' recovery quality and chronic post surgical pain after robot-assisted thyroidectomy
- Conditions
- Thyroid Cancer
- Being tested
- Systemic intravenous lidocaine infusion, normal saline infusion
- Keywords
- Systemic lidocaine, Intravenous lidocaine infusion, postoperative pain, quality of recovery, Robot-assisted thyroidectomy, thyroid cancer
- Medical subject headings
- Thyroid Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic intravenous lidocaine infusionDrug
In group L, intravenous lidocaine infusion(0.1mg/kg) for 10minutes after induction of anesthesia. After 10 minutes, lidocaine infusion continued at rate of 3mg/kg/hr during operation, and discontinued before move the patients to PACU.
normal saline infusionDrug
In group C, the patients receive same volume of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Group L | Experimental | Intravenous lidocaine infusion group Receives: Drug: Systemic intravenous lidocaine infusion |
| Group C | Placebo comparator | Intravenous normal saline infusion - control group Receives: Drug: normal saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery 40(QoR-40) score
Assessing change of the Quality of recovery 40(QoR-40) score between 24hours before and after operation
Measured: 24hours after operation day
Secondary outcomes (2)
Assessing the presence of chronic postsurgical pain(CPSP)
Measured: 24hours after operation day
aspect and site of CPSP
Measured: 24hours after operation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2015
- Study completionMay 2015
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 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
- NCT01907997
- Sponsor's protocol ID
- 4-2013-0342
- Status last verified
- Jun 2015
- First submitted
- 17 Jul 2013
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Choi KW, Nam KH, Lee JR, Chung WY, Kang SW, Joe YE, Lee JH. The Effects of Intravenous Lidocaine Infusions on the Quality of Recovery and Chronic Pain After Robotic Thyroidectomy: A Randomized, Double-Blinded, Controlled Study. World J Surg. 2017 May;41(5):1305-1312. doi: 10.1007/s00268-016-3842-1.
PubMed 27896411
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Systemic Lidocaine on Postoperative Quality of Recovery After Robot-assisted Thyroidectomy
- ClinicalTrials.gov ID
- NCT01907997
- Acronym / sponsor ID
- 4-2013-0342
- Conditions
- Thyroid Cancer
- Keywords
- Systemic lidocaine, Intravenous lidocaine infusion, postoperative pain, quality of recovery, Robot-assisted thyroidectomy, thyroid cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 Jul 2013 (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.
Systemic lidocaine infusion may improve the patients' recovery quality and chronic post surgical pain after robot-assisted thyroidectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group L | Experimental | Drug: Systemic intravenous lidocaine infusionIntravenous lidocaine infusion group |
| Group C | Placebo comparator | Drug: normal saline infusionIntravenous normal saline infusion - control group |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 20-65
- ASA class I and II
- Thyroid cancer patients who are scheduled for elective robot-assisted thyroidectomy
Key exclusion criteria (7 listed)
- Allergy to local anesthetics or contraindication to use of lidocaine
- Pregnancy
- Severe cardiovascular disease
- Renal failure
- Liver failure
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 |
|---|---|---|
| Systemic intravenous lidocaine infusionIn group L, intravenous lidocaine infusion(0.1mg/kg) for 10minutes after induction of anesthesia. After 10 minutes, lidocaine infusion continued at rate of 3mg/kg/hr during operation, and discontinued before move the patients to PACU. | Drug | Group L |
| normal saline infusionIn group C, the patients receive same volume of normal saline | Drug | Group C |
Primary outcome
Quality of recovery 40(QoR-40) score
Time frame: 24hours after operation day
Assessing change of the Quality of recovery 40(QoR-40) score between 24hours before and after operation
2 secondary outcomes
Assessing the presence of chronic postsurgical pain(CPSP)
Time frame: 24hours after operation day
aspect and site of CPSP
Time frame: 24hours after operation day
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 9 Jun 2015.
- Derived from this study: PubMed 27896411Choi KW, Nam KH, Lee JR, Chung WY, Kang SW, Joe YE, Lee JH. The Effects of Intravenous Lidocaine Infusions on the Quality of Recovery and Chronic Pain After Robotic Thyroidectomy: A Randomized, Double-Blinded, Controlled Study. World J Surg. 2017 May;41(5):1305-1312. doi: 10.1007/s00268-016-3842-1.
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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 Systemic intravenous lidocaine infusion and normal saline infusion 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 3 inclusion and 7 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 9 Jun 2015. 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?
Quality of recovery 40(QoR-40) score (time frame: 24hours after operation day). 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 NCT01907997, 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 9 Jun 2015.