Trial Outcomes & Findings for Feasibility of Perioperative Stellate Ganglion Blocks in Cardiac Surgery (NCT NCT02784587)
NCT ID: NCT02784587
Last Updated: 2019-07-08
Results Overview
Correct placement of stellate ganglion block as measured by a temperature rise of at least 1 degree Celsius in the ipsilateral hand
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
day of surgery
Results posted on
2019-07-08
Participant Flow
Participant milestones
| Measure |
Stellate Ganglion Block
All patients in the study will receive a stellate ganglion block in order to asses the feasibility and efficacy of this procedure performed by cardiac anesthesiologists in the operating room.
Stellate Ganglion Block: After induction of general anesthesia, patients will receive a stellate ganglion block using a standard and well described paratracheal technique, which typically requires about 3 minutes to perform. The patient's head will be extended and a 4-5-cm, 22-gauge needle inserted at the medial edge of the sternocleidomastoid muscle just below the level of the cricoid cartilage at the level of the transverse process of C6 (Chassaignac's tubercle) or C7 (3-5 cm above the clavicle). The non-operative hand will retract the muscle together with the carotid sheath prior to needle insertion. After advancing to the transverse process the needle will be withdrawn 2-3 mm prior to injection.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Stellate Ganglion Block
n=25 Participants
All patients in the study will receive a stellate ganglion block in order to asses the feasibility and efficacy of this procedure performed by cardiac anesthesiologists in the operating room.
Stellate Ganglion Block: After induction of general anesthesia, patients will receive a stellate ganglion block using a standard and well described paratracheal technique, which typically requires about 3 minutes to perform. The patient's head will be extended and a 4-5-cm, 22-gauge needle inserted at the medial edge of the sternocleidomastoid muscle just below the level of the cricoid cartilage at the level of the transverse process of C6 (Chassaignac's tubercle) or C7 (3-5 cm above the clavicle). The non-operative hand will retract the muscle together with the carotid sheath prior to needle insertion.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=25 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=25 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
PRIMARY outcome
Timeframe: day of surgeryCorrect placement of stellate ganglion block as measured by a temperature rise of at least 1 degree Celsius in the ipsilateral hand
Outcome measures
| Measure |
Stellate Ganglion Block
n=25 Participants
All patients in the study will receive a stellate ganglion block in order to asses the feasibility and efficacy of this procedure performed by cardiac anesthesiologists in the operating room.
Stellate Ganglion Block: After induction of general anesthesia, patients will receive a stellate ganglion block using a standard and well described paratracheal technique, which typically requires about 3 minutes to perform. The patient's head will be extended and a 4-5-cm, 22-gauge needle inserted at the medial edge of the sternocleidomastoid muscle just below the level of the cricoid cartilage at the level of the transverse process of C6 (Chassaignac's tubercle) or C7 (3-5 cm above the clavicle).
|
|---|---|
|
Success of Stellate Ganglion Block
|
22 Participants
|
SECONDARY outcome
Timeframe: Through study completion, approximately 1 yearThe current rate of atrial fibrillation is measured by the Northern New England Cardiac Database, this existing database will track a-fib rates until the patients are discharged from the hospital after surgery.
Outcome measures
Outcome data not reported
Adverse Events
Stellate Ganglion Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place