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Bilateral superficial cervical plexus blocks + local wound infiltration 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

Study 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks +/- 3 days postoperatively (at their follow up video visit)

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

914 Previous Clinical Trials

4,720,726 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

Frequently Asked Questions

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

How many people is the upper limit of participants for this research project?

"Affirmative. Clinical trials.gov highlights that this medical investigation, which was first published on April 13th 2023, is actively seeking participants. About 74 people are needed from 1 participating centre for the trial to be successful."

Answered by AI

Are there any available opportunities to participate in this trial at the moment?

"According to clinicaltrials.gov, this investigation is still open for enrolment. This trial was posted on April 13th 2023 and its details have been revised as recently as April 5th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ENDOblock: Bilateral Superficial Cervical Blocks With Local Wound Infiltration in Thyroid Surgery

2023. "ENDOblock: Bilateral Superficial Cervical Blocks With Local Wound Infiltration in Thyroid Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05805423.