Thyroid NeoplasmsNCT02205801
Study of the Efficacy of Local Analgesia as an Adjunct to General Anesthesia in Thyroidectomy and Parathyroidectomy
A study testing Superficial Cervical Plexus Block, Local Wound Infiltration and 0.9% saline in people with Thyroid Neoplasms and Goiter, Nodular, run by University of Chicago at 1 site in United States.
Trial summary
We aim to study the effect of local anesthetic when used in conjunction with general anesthesia during thyroidectomy or parathyroidectomy. We hypothesize there is equivalent pain control between bilateral superficial cervical plexus block and local wound infiltration when used in conjunction with a general anesthetic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Neoplasms, Goiter, Nodular, Thyroid Nodule
- What is being tested?
- Superficial Cervical Plexus Block, Local Wound Infiltration and 0.9% saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 17 Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient ≥ 18 years old
- Surgical indication for parathyroidectomy or thyroidectomy
Who cannot join
- Patients < 18 years old
- Patient with history of chronic opioid use
- Patient with chronic pain syndromes
- Patient with allergy to marcaine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: A Randomized Control Trial Comparing Bilateral Superficial Cervical Plexus Block and Local Wound Infiltration in Thyroidectomy and Parathyroidectomy
We aim to study the effect of local anesthetic when used in conjunction with general anesthesia during thyroidectomy or parathyroidectomy. We hypothesize there is equivalent pain control between bilateral superficial cervical plexus block and local wound infiltration when used in conjunction with a general anesthetic.
- Being tested
- Superficial Cervical Plexus Block, Local Wound Infiltration, 0.9% saline, Marcaine
- Medical subject headings
- Thyroid Neoplasms, Goiter, Nodular, Thyroid Nodule, Graves Disease, Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superficial Cervical Plexus BlockProcedure or surgery
0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.
Local Wound InfiltrationProcedure or surgery
0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.
0.9% salineDrug
MarcaineDrug
| Study group | Role | What they receive |
|---|---|---|
| superficial cervical block, active | Active comparator | After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine. Receives: Procedure: Superficial Cervical Plexus Block; Drug: Marcaine |
| local wound infiltration, placebo | Placebo comparator | After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. Receives: Procedure: Local Wound Infiltration; Drug: 0.9% saline |
| local wound infiltration, active | Active comparator | After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine. Receives: Procedure: Local Wound Infiltration; Drug: Marcaine |
| superficial cervical block, placebo | Placebo comparator | After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline. Receives: Procedure: Superficial Cervical Plexus Block; Drug: 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Fentanyl Administration
The total amount of Fentanyl administered during the procedure will be recorded.
Measured: During the procedure
Secondary outcomes (3)
Post Operative Pain
Pain scores will either be verbally reported to nursing and recorded or reported on a questionnaire. Back of neck pain scores range 0-10, throat pain scores range 0-9, incisional pain scores range 0-9 (zero means no pain and 9 or 10 means severe pain).
Measured: At four hour after operation
Post Operative Nausea Score
Nausea scores will either be verbally reported to nursing and recorded or reported on a questionnaire. The scores range 0-9 (zero means no symptom and 9 means "very severe").
Measured: At 2 weeks after operation
Total Pain Medication Utilization
Total operative opioid dosages administered converted to effective mg of Hydromorphine.
Measured: At follow up appointment 1-2 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startJul 2014
- Primary completion10 Feb 2017
- Study completion17 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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, Care provider
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raymon Grogan, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205801
- Sponsor's protocol ID
- IRB14-0374
- Status last verified
- Feb 2018
- First submitted
- 29 Jul 2014
- Last updated
- 9 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial Comparing Bilateral Superficial Cervical Plexus Block and Local Wound Infiltration in Thyroidectomy and Parathyroidectomy
- ClinicalTrials.gov ID
- NCT02205801
- Acronym / sponsor ID
- IRB14-0374
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- 10 Feb 2017 (actual)
- Study completion
- 17 Feb 2017 (actual)
- First posted
- 31 Jul 2014 (estimated)
- Results
- Posted 7 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We aim to study the effect of local anesthetic when used in conjunction with general anesthesia during thyroidectomy or parathyroidectomy. We hypothesize there is equivalent pain control between bilateral superficial cervical plexus block and local wound infiltration when used in conjunction with a general anesthetic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| superficial cervical block, active | Active comparator | Procedure: Superficial Cervical Plexus Block, Drug: MarcaineAfter induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine. |
| local wound infiltration, placebo | Placebo comparator | Procedure: Local Wound Infiltration, Drug: 0.9% salineAfter induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. |
| local wound infiltration, active | Active comparator | Procedure: Local Wound Infiltration, Drug: MarcaineAfter induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine. |
| superficial cervical block, placebo | Placebo comparator | Procedure: Superficial Cervical Plexus Block, Drug: 0.9% salineAfter induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient ≥ 18 years old
- Surgical indication for parathyroidectomy or thyroidectomy
Key exclusion criteria (4 listed)
- Patients < 18 years old
- Patient with history of chronic opioid use
- Patient with chronic pain syndromes
- Patient with allergy to marcaine
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 |
|---|---|---|
| Superficial Cervical Plexus Block0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. | Procedure or surgery | superficial cervical block, active, superficial cervical block, placebo |
| Local Wound Infiltration0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. | Procedure or surgery | local wound infiltration, active, local wound infiltration, placebo |
| 0.9% saline | Drug | local wound infiltration, placebo, superficial cervical block, placebo |
| Marcaine | Drug | local wound infiltration, active, superficial cervical block, active |
Primary outcome
Intraoperative Fentanyl Administration
Time frame: During the procedure
The total amount of Fentanyl administered during the procedure will be recorded.
3 secondary outcomes
Post Operative Pain
Time frame: At four hour after operation
Post Operative Nausea Score
Time frame: At 2 weeks after operation
Total Pain Medication Utilization
Time frame: At follow up appointment 1-2 weeks postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Raymon Grogan, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superficial Cervical Plexus Block, Local Wound Infiltration and 0.9% saline in people with Thyroid Neoplasms and Goiter, Nodular, run by University of Chicago at 1 site in United States.
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 4 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 Mar 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 7 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intraoperative Fentanyl Administration (time frame: During the procedure). 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 9 Mar 2018.