Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy (QoR-SCPB)

Yale University

Status and phase: Enrolling; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: Placebo; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06002152

2000035991

No NIH funding (Other Identifier)

Details and patient eligibility

About

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

Full 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).

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

Bupivacaine

Experimental group

Description:

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.

Treatment:

Drug: Bupivacaine

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo