Postoperative Pain
Conditions
Keywords
Superficial Cervical Plexus Block, Quality of Recovery, Postoperative Pain, Thyroidectomy
Brief summary
The goal of this clinical trial is to learn whether a superficial cervical plexus block improves quality of recovery after thyroid surgery. Investigators will compare a superficial cervical plexus block with bupivacaine compared to an identical procedure performed saline placebo to see if there is a difference in quality of recovery on the first postoperative day. The main question to answer is: • Does a superficial cervical plexus block with bupivacaine compared to placebo improve quality of recovery in patients having thyroid surgery. Participants will: * Fill out an initial preoperative survey * Be randomized to receive a superficial cervical plexus block with bupivacaine or saline placebo while under anesthesia before the surgery starts * Fill out a survey about recovery on the first day after surgery
Detailed description
Thyroid surgery is associated with mild to moderate post-operative pain, with most patients requiring opioid pain medicine postoperatively. Nerve blocks, such as the superficial cervical plexus block, are an important component of pain control plans. Superficial cervical plexus blocks have been proven to decrease pain and reduce the need for opioid medications in thyroid surgery. However, previous studies were performed before it became common practice to administer a combination of acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and steroids for thyroid surgery which also help with pain. Whether the superficial cervical plexus block improves pain control and quality of recovery in this context is unknown. This study aims to determine whether the superficial cervical plexus block has an impact on quality of recovery as measured by a survey called the Quality of Recovery-40 (QoR-40).
Interventions
DRUGBupivacaine
After anesthesia induction and prior to the start of surgery, the superficial cervical plexus block will be performed according to standard protocol by an experienced blinded clinician. In this arm, participants will receive 10 milliliters of 0.25% bupivacaine on both sides of their neck for this block. This will be the only intervention administered for purposes of this study.
DRUGPlacebo
After anesthesia induction and prior to the start of surgery, the superficial cervical plexus block will be performed according to standard protocol by an experienced blinded clinician. In this arm, participants will receive 10 milliliters of saline on both sides of their neck for this block. This will be the only intervention administered for purposes of this study.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older * American Society of Anesthesiologists Physical Status classification I-III * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Scheduled for thyroid surgery * Access to smartphone device or computer with internet connection and has an email address
Exclusion criteria
* Non-English speaking * American Society of Anesthesiologists Physical Status classification \> III * Have an intolerance or contraindication to the medications involved in the study * Undergoing repeat thyroid surgery * Undergoing surgery with planned neck dissection * Plan for admission post-operatively * Positive pregnancy test on day of surgery (for participants with child-bearing potential) * Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery-40 (QoR-40) Questionnaire Score on Postoperative Day (POD) 1 | Postoperative Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption Postoperatively | Postoperative Day 1 | This 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. |
| Number of Participants With Need for Rescue Analgesia Prior to PACU Discharge | From start of PACU stay through PACU discharge, approximately 4 hours | This 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 |
| Presence of Nausea and/or Vomiting in the PACU | From start of PACU stay through PACU discharge, approximately 4 hours | 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. |
| Need for Rescue Antiemetics in PACU | From start of PACU stay through PACU discharge, approximately 4 hours | 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. |
| Median PACU Length of Stay | From start of PACU stay through PACU discharge, approximately 4 hours | This 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. |
| Number of Participants With Reported Side Effects | Postoperative Day 1 | Participants will self-report any side effects that they experienced post-operatively from the start of their PACU stay and through POD 1. |
| Number of Participants With Any Other Modes of Analgesia, if Any Through POD 1 | Postoperative Day 1 | Participants will self-report any other modes of analgesia used post-operatively from the start of PACU stay and through POD 1. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48 Years STANDARD_DEVIATION 16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race/Ethnicity, Customized Race Black/African-American | 13 Participants |
| Race/Ethnicity, Customized Race Other/Unkown | 10 Participants |
| Race/Ethnicity, Customized Race White | 123 Participants |
| Sex/Gender, Customized Female | 63 Participants |
| Sex/Gender, Customized Male | 44 Participants |
| Sex/Gender, Customized Non-binary | 1 Participants |
| Surgery Type Hemithyroidectomy | 36 Participants |
| Surgery Type Total Thyroidectomy | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 82 |
| other Total, other adverse events | 2 / 78 | 7 / 82 |
| serious Total, serious adverse events | 1 / 78 | 1 / 82 |
Outcome results
None listed