Cervical Plexus Blocks for Postoperative Pain

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Davis

Trial Summary

What is the purpose of this trial?

This is a single center, prospective, double-blinded randomized controlled trial comparing the efficacy of bilateral superficial cervical plexus blocks (BSCPB) with local wound infiltration vs placebo with local wound infiltration in reducing thyroid surgery postoperative pain. Primary outcomes assessed are post operative pain, quality of life/recovery, post operative nausea/vomiting and opioid use.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

Over 18 years-old

You have the capacity to provide informed consent.

You are scheduled to have either a hemi- or total thyroidectomy procedure.

Exclusion Criteria

You have had surgery on your neck before.

You recently had surgery to remove lymph nodes in your neck.

Have coagulation disorders

Treatment Details

Interventions

• Bilateral Superficial Cervical Plexus Blocks and Local Wound Infiltration (Procedure)
• Placebo Injection and Local Wound Infiltration (Procedure)

Trial Overview 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.

Participant Groups

Group I: Bilateral superficial cervical plexus blocks + local wound infiltration Experimental Treatment 1 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 infiltration Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Rakesh Dixit

University of California, Davis

Chief Executive Officer since 2024

PhD in Biochemistry and Molecular Biology from the University of California, Davis

Suresh Mahabhashyam

University of California, Davis

Chief Medical Officer since 2020

MD from Bangalore Medical College