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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

Awards & highlights

QoR-SCPB Trial 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.Check my eligibility

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.See study design

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.

QoR-SCPB Trial 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.

QoR-SCPB Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Need for rescue analgesia prior to PACU discharge

Need for rescue antiemetics in PACU

Opioid consumption postoperatively

+4 more

QoR-SCPB 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

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,853 Previous Clinical Trials

2,738,401 Total Patients Enrolled

1 Trials studying Postoperative Pain

93 Patients Enrolled for Postoperative Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining opportunities to participate in this research endeavor?

"In accordance with clinicaltrials.gov, this research is presently accepting patient applications. This investigation was initially launched on November 27th 2023 and the most recent update occurred on November 30th of the same year."

Answered by AI

How many subjects have enrolled in the experiment thus far?

"Affirmative. According to clinicaltrials.gov, the medical trial initially posted on November 27th 2023 is still actively recruiting patients; its most recent update was made three days later. Currently,160 participants are sought from one healthcare centre."

Answered by AI

Has Bupivacaine been validated by the Food and Drug Administration?

"Our experts determined that Bupivacaine's safety rating was a 2, considering it is in the Phase 2 trial stage and there has been no evidence of efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy

2023. "Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06002152.