Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy

NCT ID: NCT06002152

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-27
• Study Completion Date: 2026-03-31

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).

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Bupivacaine

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jaime Hyman, MD

Role: CONTACT

jaime.hyman@yale.edu

203-785-2802

Anita M Jegarl, BS

Role: CONTACT

anita.jegarl@yale.edu

203-785-2802

Facility Contacts

Jaime Hyman, MD

Role: primary

jaime.hyman@yale.edu

Other Identifiers

No NIH funding

Identifier Type: OTHER

Identifier Source: secondary_id

2000035991

Identifier Type: -

Identifier Source: org_study_id