Clinical trial NCT06002152: Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy
Official title: Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Postoperative Pain
Keywords: Superficial Cervical Plexus Block
Quality of Recovery
Postoperative Pain
Thyroidectomy
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Quality of Recovery-40 (QoR-40) questionnaire score on postoperative day (POD) 1
timeFrame: Up to 2 days
Secondary outcomes:
measure: Opioid consumption postoperatively
timeFrame: Up to 2 days
measure: Need for rescue analgesia prior to PACU discharge
timeFrame: approximately 4 hours
measure: Presence of nausea and/or vomiting in the PACU
timeFrame: approximately 4 hours
measure: Need for rescue antiemetics in PACU
timeFrame: approximately 4 hours
measure: PACU length of stay
timeFrame: approximately 4 hours
measure: Presence of patient reported side effects
timeFrame: up to 2 days
measure: Patient reported quantity of other modes of analgesia, if any through POD 1
timeFrame: up to 2 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
References: