Thyroid DiseaseNCT02981095
Effect of Bupivacaine Application on Postthyroidectomy Pain
A study testing Thyroidectomy, Bupivacaine and Saline Solution in people with Thyroid Disease and Analgesia, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Investigators aimed to evaluate the impact of bupivacaine administration into the surgical field after total thyroidectomy on post-operative pain and analgesic requirement with a double-blind, prospective, clinical, randomized study. Pain assessment was performed with the visual analog score (VAS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Disease, Analgesia
- What is being tested?
- Thyroidectomy, Bupivacaine and Saline Solution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2010to Mar 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects need to be operated for thyroid diseases
Who cannot join
- History of previous thyroid disease,
- History of previous neck operations,
- Hypersensitivity to the drugs that were used in the study protocol,
- Spinal bone disease,
- Depression,
- Kidney failure,
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- Heart failure,
- Liver failure,
- Pulmonary failure,
- Mental retardation,
- Subjects not able to ascertain pain scoring with the visual analog score (VAS),
- Patients with American Society of Anesthesiologists (ASA) scores III or higher,
- Expected airway difficulty according to Mallampati scores,
- Sedative, steroid, and chronic analgesic drug users,
- Alcoholics
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Cerrahpasa Medical Faculty
Istanbul, 34098
About this study
Official title: Bupivacaine Application Reduces Postthyroidectomy Pain: Cerrahpaşa Experience
Investigators aimed to evaluate the impact of bupivacaine administration into the surgical field after total thyroidectomy on post-operative pain and analgesic requirement with a double-blind, prospective, clinical, randomized study.
Pain assessment was performed with the visual analog score (VAS). Participants were pre-operatively, divided into two groups randomly to receive either bupivacaine or not. One group received a 10 ml of bupivacaine solution while the other group was treated with the same volume of 0.9% sodium chloride (NaCl) through the drain after completion of total thyroidectomy procedure. All participants were anesthetized and operated with the same anesthesia and surgical team.
- Conditions
- Thyroid Disease, Analgesia
- Being tested
- Thyroidectomy, Bupivacaine, Saline Solution
- Medical subject headings
- Thyroid Diseases, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThyroidectomyProcedure or surgery
Thyroidectomy performed by the same surgical and anesthesia team
BupivacaineDrug
bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
Saline SolutionDrug
%0.9 sodium chloride solution, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Active comparator | bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation. Receives: Procedure: Thyroidectomy; Drug: Bupivacaine |
| Saline | Placebo comparator | Saline solution (%0.9 sodium chloride), 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation. Receives: Procedure: Thyroidectomy; Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain in 8 hours after surgery using VAS
Evaluation of the pain through the post-operative first 8 hours using VAS
Measured: 8th hour
Secondary outcomes (1)
Post-operative pain in in first post-operative day using VAS
Evaluation of the pain through the first post-operative day using VAS
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseaseStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan TEKSOZ, Istanbul University
- Investigators
- Yusuf BUKEY, Prof. MD, Study chair, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981095
- Sponsor's protocol ID
- IUCTF-EndSx-2010-01
- Status last verified
- Nov 2016
- First submitted
- 25 Nov 2016
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupivacaine Application Reduces Postthyroidectomy Pain: Cerrahpaşa Experience
- ClinicalTrials.gov ID
- NCT02981095
- Acronym / sponsor ID
- IUCTF-EndSx-2010-01
- Conditions
- Thyroid Disease, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 2 Dec 2016 (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.
Investigators aimed to evaluate the impact of bupivacaine administration into the surgical field after total thyroidectomy on post-operative pain and analgesic requirement with a double-blind, prospective, clinical, randomized study.
Pain assessment was performed with the visual analog score (VAS). Participants were pre-operatively, divided into two groups randomly to receive either bupivacaine or not. One group received a 10 ml of bupivacaine solution while the other group was treated with the same volume of 0.9% sodium chloride (NaCl) through the drain after completion of total thyroidectomy procedure. All participants were anesthetized and operated with the same anesthesia and surgical team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Active comparator | Procedure: Thyroidectomy, Drug: Bupivacainebupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation. |
| Saline | Placebo comparator | Procedure: Thyroidectomy, Drug: Saline SolutionSaline solution (%0.9 sodium chloride), 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects need to be operated for thyroid diseases
Key exclusion criteria (15 listed)
- History of previous thyroid disease,
- History of previous neck operations,
- Hypersensitivity to the drugs that were used in the study protocol,
- Spinal bone disease,
- Depression,
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 |
|---|---|---|
| ThyroidectomyThyroidectomy performed by the same surgical and anesthesia team | Procedure or surgery | Bupivacaine, Saline |
| Bupivacainebupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation. | Drug | Bupivacaine |
| Saline Solution%0.9 sodium chloride solution, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation. | Drug | Saline |
Primary outcome
Post-operative pain in 8 hours after surgery using VAS
Time frame: 8th hour
Evaluation of the pain through the post-operative first 8 hours using VAS
1 secondary outcome
Post-operative pain in in first post-operative day using VAS
Time frame: 1 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 2 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Yusuf BUKEY, Prof. MD study chair
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thyroidectomy, Bupivacaine and Saline Solution in people with Thyroid Disease and Analgesia, run by Istanbul University at 1 site in Turkey (Türkiye).
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 15 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 2 Dec 2016. 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 Turkey (Türkiye). 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?
Post-operative pain in 8 hours after surgery using VAS (time frame: 8th hour). 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 2 Dec 2016.