Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy

Postoperative Pain Clinical Trial

— QoR-SCPB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06002152
• Other study ID #: 2000035991
• Secondary ID: No NIH funding
• Status: Recruiting
• Phase: Phase 2
• Start date: November 27, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Yale University
• Contact: Jaime Hyman, MD
• Phone: 203-785-2802
• Email: jaime.hyman[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 2 days
Secondary	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	approximately 4 hours
Secondary	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.	approximately 4 hours
Secondary	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.	approximately 4 hours
Secondary	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.	approximately 4 hours
Secondary	Presence of patient 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.	up to 2 days
Secondary	Patient reported quantity of 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.	up to 2 days