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Cervical Plexus Blocks for Postoperative Pain

N/A
Recruiting
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks +/- 3 days postoperatively (at their follow up video visit)
Awards & highlights

Summary

This trial compares two methods of reducing pain after thyroid surgery: BSCPB and placebo with local wound infiltration. Outcomes assessed are pain, quality of life, nausea/vomiting and opioid use.

Who is the study for?
This trial is for adults over 18 who can consent and are having thyroid surgery (hemi- or total thyroidectomy). It's not for those with previous neck surgeries, coagulation disorders, kidney issues, pregnancy, bupivacaine allergy, chronic pain conditions, recent steroid or opioid use, substernal goiters, or an inability to take NSAIDs.Check my eligibility
What is being tested?
The study tests if bilateral superficial cervical plexus blocks (BSCPB) with local wound infiltration reduce postoperative pain better than placebo with local wound infiltration in thyroid surgery. It measures pain relief quality of life recovery nausea vomiting and opioid consumption.See study design
What are the potential side effects?
Possible side effects may include discomfort at the injection site reactions to bupivacaine such as numbness tingling dizziness allergic responses and potential complications from block placement like bleeding or nerve injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks +/- 3 days postoperatively (at their follow up video visit)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks +/- 3 days postoperatively (at their follow up video visit) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of nausea and/or vomiting post operatively
does the addition of bilateral superficial cervical plexus blocks with local wound infiltration decrease postoperative pain after thyroid surgery
does the addition of bilateral superficial cervical plexus blocks with local wound infiltration increase patient quality of life/recovery after thyroid surgery
Secondary outcome measures
dysphagia (difficulty swallowing)
hoarseness

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bilateral superficial cervical plexus blocks + local wound infiltrationExperimental Treatment1 Intervention
the bilateral superficial cervical plexus block will be performed with 10mL of 0.25% Bupivacaine injected bilaterally (total 20mL) at Erb's point in the lateral neck, which is located at the mid-point between the mastoid process and the posterior border of the clavicular head of the sternocleidomastoid muscle. The injection is just below the lateral border of the sternocleidomastoid muscle, which produces surface level anesthesia of the neck, targeting superficial nerves of the cervical plexus. Then 10mL of 0.25% Bupivacaine will be injected at the planned neck incision (local wound infiltration) on the anterior neck. These will be done intra-operative and only once
Group II: placebo + local wound infiltrationPlacebo Group1 Intervention
10mL of 0.25% bupivacaine injected at the planned neck incision (local wound infiltration), with 10mL of normal saline injected at bilateral Erb's point (total 20mL) (placebo at site of BSCPB). These will be done intra-operative and only once.

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Who is running the clinical trial?

University of California, DavisLead Sponsor
919 Previous Clinical Trials
4,720,818 Total Patients Enrolled

Media Library

Postoperative Pain Research Study Groups: Bilateral superficial cervical plexus blocks + local wound infiltration, placebo + local wound infiltration
Bilateral Superficial Cervical Plexus Blocks and Local Wound Infiltration 2023 Treatment Timeline for Medical Study. Trial Name: NCT05805423 — N/A
~12 spots leftby Nov 2024
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