NCT02205801 · STUDY IN CONTEXT
Study of the Efficacy of Local Analgesia as an Adjunct to General Anesthesia in Thyroidectomy and Parathyroidectomy
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
The total amount of Fentanyl administered during the procedure will be recorded.
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).
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").
Total operative opioid dosages administered converted to effective mg of Hydromorphine.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- trial label
- Study of the Efficacy of Local Analgesia as an Adjunct to General Anesthesia in Thyroidectomy and Parathyroidectomy
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 4
- harms Count
- 4
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- outcome key
- om-0000
- source section id
- NCT02205801-om-0000
- source outcome index
- 0
- endpoint
- Intraoperative Fentanyl Administration
- endpoint definition
- The total amount of Fentanyl administered during the procedure will be recorded.
- time origin
- During the procedure
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- outcome key
- om-0001
- source section id
- NCT02205801-om-0001
- source outcome index
- 1
- endpoint
- Post Operative Pain
- endpoint definition
- 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 origin
- At four hour after operation
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- outcome key
- om-0002
- source section id
- NCT02205801-om-0002
- source outcome index
- 2
- endpoint
- Post Operative Nausea Score
- endpoint definition
- 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 origin
- At 2 weeks after operation
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- outcome key
- om-0003
- source section id
- NCT02205801-om-0003
- source outcome index
- 3
- endpoint
- Total Pain Medication Utilization
- endpoint definition
- Total operative opioid dosages administered converted to effective mg of Hydromorphine.
- time origin
- At follow up appointment 1-2 weeks postoperatively
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Superficial Cervical Block, Active
- regimen
- After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine. Superficial Cervical Plexus Block: 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. Marcaine
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02205801-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Superficial Cervical Block, Placebo
- regimen
- After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline. Superficial Cervical Plexus Block: 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. 0.9% saline
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02205801-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Local Wound Infiltration, Active
- regimen
- After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine. Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. Marcaine
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02205801-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Local Wound Infiltration, Placebo
- regimen
- After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. Local Wound Infiltration: 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% saline
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02205801-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Superficial Cervical Block, Active
- regimen
- After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine. Superficial Cervical Plexus Block: 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. Marcaine
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02205801-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Superficial Cervical Block, Placebo
- regimen
- After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline. Superficial Cervical Plexus Block: 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. 0.9% saline
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02205801-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Local Wound Infiltration, Active
- regimen
- After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine. Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. Marcaine
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02205801-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Local Wound Infiltration, Placebo
- regimen
- After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. Local Wound Infiltration: 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% saline
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02205801-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Superficial Cervical Block, Active
- regimen
- After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.25% Marcaine. Superficial Cervical Plexus Block: 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. Marcaine
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02205801-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Superficial Cervical Block, Placebo
- regimen
- After induction of general anesthesia the surgeon will perform a bilateral superficial cervical plexus block using 0.9% saline. Superficial Cervical Plexus Block: 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. 0.9% saline
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02205801-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Local Wound Infiltration, Active
- regimen
- After induction of general anesthesia the surgeon will perform a local wound infiltration using 0.25% Marcaine. Local Wound Infiltration: 0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy. Marcaine
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02205801-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- outcome key
- om-0002
- arm key
- OG003
- arm label
- Local Wound Infiltration, Placebo
- regimen
- After induction of general anesthesia the surgeon will perform local wound infiltration using 0.9% Saline. Local Wound Infiltration: 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% saline
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02205801-om-0002#groups/OG003
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- harm key
- EG000
- source section id
- NCT02205801-ae
- event group key
- EG000
- event group label
- Superficial Cervical Block, Active
- serious affected
- 0
- serious at risk
- 11
- other affected
- 0
- other at risk
- 11
- frequency threshold
- 5
- collection period
- 8 months
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- harm key
- EG001
- source section id
- NCT02205801-ae
- event group key
- EG001
- event group label
- Superficial Cervical Block, Placebo
- serious affected
- 0
- serious at risk
- 8
- other affected
- 0
- other at risk
- 8
- frequency threshold
- 5
- collection period
- 8 months
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- harm key
- EG002
- source section id
- NCT02205801-ae
- event group key
- EG002
- event group label
- Local Wound Infiltration, Active
- serious affected
- 0
- serious at risk
- 9
- other affected
- 0
- other at risk
- 9
- frequency threshold
- 5
- collection period
- 8 months
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-head-and-neck-neoplasm
- nct id
- NCT02205801
- harm key
- EG003
- source section id
- NCT02205801-ae
- event group key
- EG003
- event group label
- Local Wound Infiltration, Placebo
- serious affected
- 0
- serious at risk
- 8
- other affected
- 0
- other at risk
- 8
- frequency threshold
- 5
- collection period
- 8 months
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice
Triangle