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NCT02205801 · ADVERSE EVENTS

Adverse events

Study of the Efficacy of Local Analgesia as an Adjunct to General Anesthesia in Thyroidectomy and Parathyroidectomy · Source last updated 2018-03-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
8 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Superficial Cervical Block, Active

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

0 / 110 / 110 / 11
Superficial Cervical Block, Placebo

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

0 / 80 / 80 / 8
Local Wound Infiltration, Active

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

0 / 90 / 90 / 9
Local Wound Infiltration, Placebo

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

0 / 80 / 80 / 8

Group identifiers: EG000: Superficial Cervical Block, Active · EG001: Superficial Cervical Block, Placebo · EG002: Local Wound Infiltration, Active · EG003: Local Wound Infiltration, Placebo

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

      Complete source fields
      event Groups
      1. deaths Num Affected
        0
        deaths Num At Risk
        11
        description
        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
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        11
        serious Num Affected
        0
        serious Num At Risk
        11
        title
        Superficial Cervical Block, Active
      2. deaths Num Affected
        0
        deaths Num At Risk
        8
        description
        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
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        8
        serious Num Affected
        0
        serious Num At Risk
        8
        title
        Superficial Cervical Block, Placebo
      3. deaths Num Affected
        0
        deaths Num At Risk
        9
        description
        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
        id
        EG002
        other Num Affected
        0
        other Num At Risk
        9
        serious Num Affected
        0
        serious Num At Risk
        9
        title
        Local Wound Infiltration, Active
      4. deaths Num Affected
        0
        deaths Num At Risk
        8
        description
        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
        id
        EG003
        other Num Affected
        0
        other Num At Risk
        8
        serious Num Affected
        0
        serious Num At Risk
        8
        title
        Local Wound Infiltration, Placebo
      frequency Threshold
      5
      time Frame
      8 months

      Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

      Preserved source evidence · Not medical advice