Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy

NCT06002152 | Completed Phase 2 FDA Drug

• 2 other identifiers: 2000035991No NIH funding
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain

Keywords

Superficial Cervical Plexus Block; Quality of Recovery; Postoperative Pain; Thyroidectomy

Outcome Measures

Primary Outcomes (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.

  Up to 2 days

Secondary Outcomes (7)

• Opioid consumption postoperatively

  Up to 2 days

• Need for rescue analgesia prior to PACU discharge

  approximately 4 hours

• Presence of nausea and/or vomiting in the PACU

  approximately 4 hours

• Need for rescue antiemetics in PACU

  approximately 4 hours

• PACU length of stay

  approximately 4 hours

Study Arms (2)

Bupivacaine

EXPERIMENTAL

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.

Drug: Bupivacaine

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Bupivacaine DRUG

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.

Bupivacaine

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: November 27, 2023
• Primary Completion: February 3, 2026
• Study Completion: February 3, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)