AzTrials
AzTrials

Postoperative PainPhase 2QoR-SCPBNCT06002152

Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy

A Phase 2 study testing Bupivacaine in people with Postoperative Pain, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postoperative Pain
What is being tested?
Bupivacaine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
164 participants
Where
1 siteUnited States
Study dates
27 Nov 2023to 3 Feb 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale School of Medicine

    New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy: A Randomized Controlled Trial

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:

Read more
  • 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
Read the 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).

Being tested
Bupivacaine, Placebo
Keywords
Superficial Cervical Plexus Block, Quality of Recovery, Postoperative Pain, Thyroidectomy
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BupivacaineDrug

    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.

  • PlaceboDrug

    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.

Study groups in NCT06002152
Study groupRoleWhat they receive
BupivacaineExperimentalParticipants 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.
Receives: Drug: Bupivacaine
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Recovery-40 (QoR-40) Questionnaire Score on Postoperative Day (POD) 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.

    Measured: Postoperative Day 1

Secondary outcomes (7)

  1. Opioid Consumption Postoperatively

    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.

    Measured: Postoperative Day 1

  2. Number of Participants With Need for Rescue Analgesia Prior to PACU Discharge

    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

    Measured: From start of PACU stay through PACU discharge, approximately 4 hours

  3. Presence of Nausea and/or Vomiting in the PACU

    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.

    Measured: From start of PACU stay through PACU discharge, approximately 4 hours

  4. Need for Rescue Antiemetics in PACU

    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.

    Measured: From start of PACU stay through PACU discharge, approximately 4 hours

  5. Median PACU Length of Stay

    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.

    Measured: From start of PACU stay through PACU discharge, approximately 4 hours

  6. Number of Participants With Reported Side Effects

    Participants will self-report any side effects that they experienced post-operatively from the start of their PACU stay and through POD 1.

    Measured: Postoperative Day 1

  7. Number of Participants With Any Other Modes of Analgesia, if Any Through POD 1

    Participants will self-report any other modes of analgesia used post-operatively from the start of PACU stay and through POD 1.

    Measured: Postoperative Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start27 Nov 2023
  3. Primary completion3 Feb 2026
  4. Study completion3 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06002152
Sponsor's protocol ID
2000035991
Other IDs
No NIH funding
Acronym
QoR-SCPB
Status last verified
Jul 2026
First submitted
14 Aug 2023
Last updated
13 Aug 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jegarl AM, Martin M, Cormier NR, Tanella A, Schafer D, Zhao X, Dawlagala N, Yonn-Brown T, Girod A, Lin HM, Ramirez AG, Gibson CE, Ogilvie JB, Hyman JB. Superficial Cervical Plexus Block and Quality of Recovery after Thyroidectomy: A Randomized Clinical Trial. Anesthesiology. 2026 Jun 10. doi: 10.1097/ALN.0000000000006200. Online ahead of print.

    PubMed 42268604

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bupivacaine in people with Postoperative Pain, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Recovery-40 (QoR-40) Questionnaire Score on Postoperative Day (POD) 1 (time frame: Postoperative Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06002152, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in