Trial Outcomes & Findings for Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy (NCT NCT06002152)
NCT ID: NCT06002152
Last Updated: 2026-08-13
Results Overview
The QoR-40 is a widely used and well validated metric assessing postoperative quality of recovery. It includes 5 subsections investigating the dimensions of 'Emotional State' (9 questions), 'Physical Comfort' (12 questions), 'Psychological Support) (7 questions), 'Physical Independence' (5 questions), and 'Pain' (7 questions) for a total of 40 questions. The questions are scored on a 5-point Likert scale. Possible responses range from 1 = 'none of the time' to 5 = 'all of the time'. For negative items, the Likert scale is reversed. The individual scores are summed for the total score which can range from 40 points to 200 points. A higher score indicates better post-operative quality of recovery. Participants will be sent an electronic link to the survey via their email. They will complete the surveys privately from their own electronic devices. Investigators will then compare the changes in pre-operative vs POD 1 QoR-40 scores between the two groups.
COMPLETED
PHASE2
164 participants
Postoperative Day 1
2026-08-13
Participant Flow
Participants were enrolled at two ambulatory surgical sites: Yale New Haven Hospital in New Haven, CT, and Shoreline Surgery Center in Guilford, CT, from November 27, 2023 to February 3, 2026.
164 patients consented to participate. Two patients had surgery cancellations, one patient was a screen failure due to a history of chronic kidney disease, and one patient withdrew consent on the day of surgery.
Participant milestones
| Measure |
Bupivacaine
Participants randomized to this arm will receive 10ml of 0.25% bupivacaine on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
Placebo
Participants randomized to this arm will receive 10ml of saline on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
82
|
|
Overall Study
COMPLETED
|
78
|
82
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy
Baseline characteristics by cohort
| Measure |
Bupivacaine
n=78 Participants
Participants randomized to this arm will receive 10ml of 0.25% bupivacaine on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
Placebo
n=82 Participants
Participants randomized to this arm will receive 10ml of saline on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 Years
STANDARD_DEVIATION 16 • n=1 Participants
|
48 Years
STANDARD_DEVIATION 16 • n=1 Participants
|
48 Years
STANDARD_DEVIATION 16 • n=1 Participants
|
|
Sex/Gender, Customized
Female
|
52 Participants
n=1 Participants
|
63 Participants
n=1 Participants
|
115 Participants
n=1 Participants
|
|
Sex/Gender, Customized
Male
|
25 Participants
n=1 Participants
|
19 Participants
n=1 Participants
|
44 Participants
n=1 Participants
|
|
Sex/Gender, Customized
Non-binary
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=1 Participants
|
9 Participants
n=1 Participants
|
17 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=1 Participants
|
68 Participants
n=1 Participants
|
135 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=1 Participants
|
5 Participants
n=1 Participants
|
8 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African-American
|
6 Participants
n=1 Participants
|
13 Participants
n=1 Participants
|
19 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
64 Participants
n=1 Participants
|
59 Participants
n=1 Participants
|
123 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Race · Other/Unkown
|
8 Participants
n=1 Participants
|
10 Participants
n=1 Participants
|
18 Participants
n=1 Participants
|
|
Surgery Type
Total Thyroidectomy
|
50 Participants
n=1 Participants
|
46 Participants
n=1 Participants
|
96 Participants
n=1 Participants
|
|
Surgery Type
Hemithyroidectomy
|
28 Participants
n=1 Participants
|
36 Participants
n=1 Participants
|
64 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Postoperative Day 1The QoR-40 is a widely used and well validated metric assessing postoperative quality of recovery. It includes 5 subsections investigating the dimensions of 'Emotional State' (9 questions), 'Physical Comfort' (12 questions), 'Psychological Support) (7 questions), 'Physical Independence' (5 questions), and 'Pain' (7 questions) for a total of 40 questions. The questions are scored on a 5-point Likert scale. Possible responses range from 1 = 'none of the time' to 5 = 'all of the time'. For negative items, the Likert scale is reversed. The individual scores are summed for the total score which can range from 40 points to 200 points. A higher score indicates better post-operative quality of recovery. Participants will be sent an electronic link to the survey via their email. They will complete the surveys privately from their own electronic devices. Investigators will then compare the changes in pre-operative vs POD 1 QoR-40 scores between the two groups.
Outcome measures
| Measure |
Bupivacaine
n=78 Participants
Participants randomized to this arm will receive 10ml of 0.25% bupivacaine on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
Placebo
n=82 Participants
Participants randomized to this arm will receive 10ml of saline on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
|---|---|---|
|
Quality of Recovery-40 (QoR-40) Questionnaire Score on Postoperative Day (POD) 1
|
174 Score
Interval 170.0 to 178.0
|
173 Score
Interval 169.0 to 177.0
|
SECONDARY outcome
Timeframe: Postoperative Day 1This outcome will be measured in morphine milligram equivalents. The data will be obtained from electronic medical record (EMR) review. It will be measured from the start of the participant's post-anesthesia care unit (PACU) stay and through POD 1.
Outcome measures
| Measure |
Bupivacaine
n=78 Participants
Participants randomized to this arm will receive 10ml of 0.25% bupivacaine on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
Placebo
n=82 Participants
Participants randomized to this arm will receive 10ml of saline on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
|---|---|---|
|
Opioid Consumption Postoperatively
|
0 Morphine milligram equivalents
Interval 0.0 to 8.0
|
2 Morphine milligram equivalents
Interval 0.0 to 20.0
|
SECONDARY outcome
Timeframe: From start of PACU stay through PACU discharge, approximately 4 hoursThis outcome will be measured as "Yes" or "No". The data will be obtained from EMR review from the start of participant's PACU stay to end of participant's PACU stay
Outcome measures
| Measure |
Bupivacaine
n=78 Participants
Participants randomized to this arm will receive 10ml of 0.25% bupivacaine on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
Placebo
n=82 Participants
Participants randomized to this arm will receive 10ml of saline on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
|---|---|---|
|
Number of Participants With Need for Rescue Analgesia Prior to PACU Discharge
No
|
49 Participants
|
41 Participants
|
|
Number of Participants With Need for Rescue Analgesia Prior to PACU Discharge
Yes
|
29 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: From start of PACU stay through PACU discharge, approximately 4 hoursPopulation: Nausea and vomiting occurrence was documented in nursing flowsheets. It was missing from the flowsheet in 8 participants in the bupivacaine group and 6 participants in the placebo group.
This outcome will be measured as "Yes" or "No". The data will be obtained from EMR review. It will be measured from the start of participant's PACU stay to end of participant's PACU stay.
Outcome measures
| Measure |
Bupivacaine
n=70 Participants
Participants randomized to this arm will receive 10ml of 0.25% bupivacaine on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
Placebo
n=76 Participants
Participants randomized to this arm will receive 10ml of saline on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
|---|---|---|
|
Presence of Nausea and/or Vomiting in the PACU
Yes
|
3 Participants
|
7 Participants
|
|
Presence of Nausea and/or Vomiting in the PACU
No
|
67 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: From start of PACU stay through PACU discharge, approximately 4 hoursThis outcome will be measured as "Yes" or "No". The data will be obtained from EMR review. It will be measured from the start of participant's PACU stay to end of participant's PACU stay.
Outcome measures
| Measure |
Bupivacaine
n=78 Participants
Participants randomized to this arm will receive 10ml of 0.25% bupivacaine on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
Placebo
n=82 Participants
Participants randomized to this arm will receive 10ml of saline on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
|---|---|---|
|
Need for Rescue Antiemetics in PACU
Yes
|
3 Participants
|
13 Participants
|
|
Need for Rescue Antiemetics in PACU
No
|
75 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: From start of PACU stay through PACU discharge, approximately 4 hoursThis outcome will be measured in minutes. The data will be obtained from EMR review. It will be measured from the start of participant's PACU stay to end of participant's PACU stay.
Outcome measures
| Measure |
Bupivacaine
n=78 Participants
Participants randomized to this arm will receive 10ml of 0.25% bupivacaine on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
Placebo
n=82 Participants
Participants randomized to this arm will receive 10ml of saline on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
|---|---|---|
|
Median PACU Length of Stay
|
132 Minutes
Interval 106.0 to 183.0
|
118 Minutes
Interval 89.0 to 173.0
|
SECONDARY outcome
Timeframe: Postoperative Day 1Participants will self-report any side effects that they experienced post-operatively from the start of their PACU stay and through POD 1.
Outcome measures
| Measure |
Bupivacaine
n=78 Participants
Participants randomized to this arm will receive 10ml of 0.25% bupivacaine on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
Placebo
n=82 Participants
Participants randomized to this arm will receive 10ml of saline on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
|---|---|---|
|
Number of Participants With Reported Side Effects
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Postoperative Day 1Participants will self-report any other modes of analgesia used post-operatively from the start of PACU stay and through POD 1.
Outcome measures
| Measure |
Bupivacaine
n=78 Participants
Participants randomized to this arm will receive 10ml of 0.25% bupivacaine on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
Placebo
n=82 Participants
Participants randomized to this arm will receive 10ml of saline on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
|---|---|---|
|
Number of Participants With Any Other Modes of Analgesia, if Any Through POD 1
|
78 Participants
|
82 Participants
|
Adverse Events
Bupivacaine
Placebo
Serious adverse events
| Measure |
Bupivacaine
n=78 participants at risk
Participants randomized to this arm will receive 10ml of 0.25% bupivacaine on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
Placebo
n=82 participants at risk
Participants randomized to this arm will receive 10ml of saline on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
|---|---|---|
|
Surgical and medical procedures
Hematoma requiring return to operating room
|
0.00%
0/78 • From enrollment through POD 1, 2 days
|
1.2%
1/82 • From enrollment through POD 1, 2 days
|
|
Endocrine disorders
Admitted for overnight observation due to low parathyroid hormone level
|
1.3%
1/78 • From enrollment through POD 1, 2 days
|
0.00%
0/82 • From enrollment through POD 1, 2 days
|
Other adverse events
| Measure |
Bupivacaine
n=78 participants at risk
Participants randomized to this arm will receive 10ml of 0.25% bupivacaine on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
Placebo
n=82 participants at risk
Participants randomized to this arm will receive 10ml of saline on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Recurrent laryngeal nerve injury
|
0.00%
0/78 • From enrollment through POD 1, 2 days
|
6.1%
5/82 • From enrollment through POD 1, 2 days
|
|
Renal and urinary disorders
Postoperative urinary retention
|
1.3%
1/78 • From enrollment through POD 1, 2 days
|
1.2%
1/82 • From enrollment through POD 1, 2 days
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip and cough
|
0.00%
0/78 • From enrollment through POD 1, 2 days
|
1.2%
1/82 • From enrollment through POD 1, 2 days
|
|
Surgical and medical procedures
Dizziness
|
1.3%
1/78 • From enrollment through POD 1, 2 days
|
0.00%
0/82 • From enrollment through POD 1, 2 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place