An interventional study of Superficial Cervical Plexus Block and Local Wound Infiltration in Thyroid Neoplasms, Goiter, Nodular and Thyroid Nodule, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-09.
Sponsored by University of Chicago · Not applicable, Interventional, and Treatment
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.
207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.
This study's enrollment of 36 is below the median of 75 across 121 interventional studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.
Compared within Thyroid Nodule, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Thyroid Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine.
Procedure: Superficial Cervical Plexus Block · Drug: Marcaine
After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline.
Procedure: Local Wound Infiltration · Drug: 0.9% saline
After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine.
Procedure: Local Wound Infiltration · Drug: Marcaine
After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline.
Procedure: Superficial Cervical Plexus Block · Drug: 0.9% saline
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.
0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.
Intraoperative Fentanyl Administration
The total amount of Fentanyl administered during the procedure will be recorded.
Time frame: During the procedure
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).
Time frame: 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").
Time frame: At 2 weeks after operation
Total Pain Medication Utilization
Total operative opioid dosages administered converted to effective mg of Hydromorphine.
Time frame: At follow up appointment 1-2 weeks postoperatively
| Milestone | Superficial Cervical Block, Active | Superficial Cervical Block, Placebo | Local Wound Infiltration, Active | Local Wound Infiltration, Placebo |
|---|---|---|---|---|
| Started | 11 | 8 | 9 | 8 |
| Completed | 11 | 8 | 9 | 8 |
| Not completed | 0 | 0 | 0 | 0 |
The total amount of Fentanyl administered during the procedure will be recorded.
| mcg | Superficial Cervical Block, Active | Superficial Cervical Block, Placebo | Local Wound Infiltration, Active | Local Wound Infiltration, Placebo |
|---|---|---|---|---|
| Intraoperative Fentanyl Administration | 187.5 ± 89.2 | 185.7 ± 80.2 | 144.2 ± 65.0 | 156.3 ± 43.8 |
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).
| units on a scale | Superficial Cervical Block, Active | Superficial Cervical Block, Placebo | Local Wound Infiltration, Active | Local Wound Infiltration, Placebo |
|---|---|---|---|---|
| Incision | 3 ± 2.6 | 2.8 ± 1.6 | 4.4 ± 2.9 | 2.9 ± 2 |
| Back of neck | 1.4 ± 1.3 | 3.4 ± 3.4 | 2.3 ± 2.1 | 2.4 ± 2.0 |
| Throat | 4.3 ± 1.6 | 5.3 ± 2.3 | 6.4 ± 1.9 | 3.9 ± 2.3 |
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").
| units on a scale | Superficial Cervical Block, Active | Superficial Cervical Block, Placebo | Local Wound Infiltration, Active | Local Wound Infiltration, Placebo |
|---|---|---|---|---|
| Incision | 1.3 ± 0.5 | 1.0 ± 0 | 1.4 ± 1.1 | 1.4 ± 0.9 |
| Back of neck | 1.7 ± 1.0 | 1.2 ± 0.4 | 1.3 ± 0.5 | 1.0 ± 0 |
| Throat | 1.4 ± 0.8 | 1.0 ± 0 | 2.0 ± 1.5 | 1.2 ± 0.4 |
Total operative opioid dosages administered converted to effective mg of Hydromorphine.
| mg | Superficial Cervical Block, Active | Superficial Cervical Block, Placebo | Local Wound Infiltration, Active | Local Wound Infiltration, Placebo |
|---|---|---|---|---|
| Total Pain Medication Utilization | 0.56 ± 0.43 | 0.71 ± 0.4 | 0.84 ± 0.47 | 0.79 ± 0.52 |
Collected over 8 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Superficial Cervical Block, Active | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Superficial Cervical Block, Placebo | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Local Wound Infiltration, Active | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Local Wound Infiltration, Placebo | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Continuous(years) | Superficial Cervical Block, Active | Superficial Cervical Block, Placebo | Local Wound Infiltration, Active | Local Wound Infiltration, Placebo | Total |
|---|---|---|---|---|---|
| Mean | 52 ± 13.1 | 47.4 ± 15.5 | 48.2 ± 9.5 | 51.6 ± 15.3 | 49.4 ± 13 |
| Sex: Female, Male(Participants) | Superficial Cervical Block, Active | Superficial Cervical Block, Placebo | Local Wound Infiltration, Active | Local Wound Infiltration, Placebo | Total |
|---|---|---|---|---|---|
| Female | 9 | 6 | 8 | 4 | 27 |
| Male | 2 | 2 | 1 | 4 | 9 |
| Race (NIH/OMB)(Participants) | Superficial Cervical Block, Active | Superficial Cervical Block, Placebo | Local Wound Infiltration, Active | Local Wound Infiltration, Placebo | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 1 | 3 | 2 | 10 |
| White | 7 | 6 | 6 | 6 | 25 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2014 to primary completion in Feb 2017, 31 months.
Results were first posted in Feb 2018, 11 months after primary completion.
Of 67 non-industry interventional studies with no phase under Thyroid Nodule, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 46. This study's 31 months is close to that.
Counting every sponsor, half of 71 studies reached it within 30 months; a quarter within 14 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Bupivacaine