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Bupivacaine for Postoperative Pain (QoR-SCPB Trial)

Phase 2

Recruiting

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for thyroid surgery

Aged 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 4 hours

Summary

This trial will compare bupivacaine to a saline placebo to see if there is an improvement in quality of recovery after thyroid surgery.

Who is the study for?

This trial is for adults over 18 who are scheduled for thyroid surgery, can access a smartphone or computer with internet, and are willing to follow the study's procedures. They must be classified as ASA Physical Status I-III, indicating they have mild to moderate systemic disease but not incapacitating.

What is being tested?

The study tests if a superficial cervical plexus block using bupivacaine improves recovery quality after thyroidectomy compared to a placebo (saline). Participants will receive one of these treatments randomly before surgery and complete surveys preoperatively and on the first day post-surgery.

What are the potential side effects?

Bupivacaine may cause side effects such as numbness in the injection area, weakness, dizziness, nausea or vomiting. Serious side effects like allergic reactions or seizures are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery on my thyroid.

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I am 18 years old or older.

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My overall health is good to moderately impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 4 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 4 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality of Recovery-40 (QoR-40) questionnaire score on postoperative day (POD) 1

Secondary study objectives

Need for rescue analgesia prior to PACU discharge

Need for rescue antiemetics in PACU

Opioid consumption postoperatively

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BupivacaineExperimental Treatment1 Intervention

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 II: PlaceboPlacebo Group1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupivacaine

2013

Completed Phase 4

~1530

0 / 3Eligibility criteria met