Cervical Plexus Blocks for Postoperative Pain

Overseen By Claire E Graves, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Anticoagulants, Opioids, NSAIDs, others

Disqualifiers: Previous neck surgery, Coagulation disorders, Pregnancy, others

Compensation: Varies

Number of Visits: 3

Duration: Day of surgery

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a bilateral superficial cervical plexus block can reduce pain after thyroid surgery. It compares this nerve block combined with standard pain management techniques to standard pain management alone. The primary focus is on reducing pain, improving recovery and quality of life, and lessening the need for opioids after surgery. The trial seeks participants planning to undergo thyroid surgery who have not had previous neck surgery or chronic pain issues. As an unphased trial, it offers participants the chance to contribute to important research that could enhance post-surgical care for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used opioids or pain medications in the two weeks before surgery.

What prior data suggests that bilateral superficial cervical plexus blocks are safe for postoperative pain management?

Research has shown that the Bilateral Superficial Cervical Plexus Block (BSCPB) is generally safe and well-tolerated. Studies have found that it effectively reduces post-surgical pain and decreases the need for additional pain medication, as well as reducing nausea and vomiting. These studies highlight BSCPB as a reliable method for managing pain after certain surgeries. No serious safety issues were reported, making it a promising option for those seeking pain relief after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using bilateral superficial cervical plexus blocks for postoperative pain management because this approach specifically targets the superficial nerves of the cervical plexus, offering potentially enhanced pain relief. Unlike standard treatments that may rely solely on systemic medications, this technique involves a local anesthetic, Bupivacaine, administered directly at Erb's point and the neck incision site, which could result in more focused and effective pain control. Additionally, this method could minimize the need for systemic opioids, reducing associated side effects and improving patient recovery.

What evidence suggests that this trial's treatments could be effective for reducing postoperative pain after thyroid surgery?

In this trial, participants will receive either bilateral superficial cervical plexus blocks (BSCPB) with local wound infiltration or a placebo injection with local wound infiltration. Research has shown that BSCPB can greatly reduce pain after thyroid surgery. Most studies find that this treatment significantly lessens pain and discomfort. It also reduces the need for extra pain medication, such as opioids, and helps prevent nausea and vomiting after surgery. The procedure involves injecting a local anesthetic to numb specific neck nerves, easing post-operative pain. Overall, BSCPB offers a promising method for managing pain following thyroid surgery. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment

Enrollment period until 74 participants are acquired

Varies until 74 participants are enrolled

Treatment

Participants undergo thyroid surgery with either bilateral superficial cervical plexus blocks or placebo

Day of surgery

1 visit (in-person)

Immediate Postoperative Monitoring

Participants are observed for at least 4 hours in the post anesthesia care unit for postoperative complications and pain control

4-5 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain and quality of recovery assessments

2 weeks

1 video visit, 1 phone call

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

A superficial cervical plexus block (SCPB) significantly improved the quality of recovery in patients undergoing elective anterior cervical discectomy and fusion (ACDF), as indicated by higher QoR-40 scores at 24 hours post-surgery.

Despite the benefits in recovery quality, the SCPB did not reduce postoperative opioid consumption or affect discharge times compared to patients who did not receive the block.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of superficial cervical plexus block on postoperative quality of recovery after anterior cervical discectomy and fusion: a randomized controlled trial. Mariappan, R., Mehta, J., Massicotte, E., et al.[2015]

Bilateral superficial cervical plexus block significantly reduces the amount of general anesthesia needed during thyroid surgery, with patients receiving bupivacaine or levobupivacaine requiring less desflurane compared to those receiving saline.

Patients who received bupivacaine or levobupivacaine experienced significantly lower postoperative pain and required analgesics less frequently, leading to shorter hospital stays and improved recovery in the first 24 hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral superficial cervical plexus block combined with general anesthesia administered in thyroid operations. Shih, ML., Duh, QY., Hsieh, CB., et al.[2022]

In a study of 111 patients undergoing total thyroidectomy, bilateral superficial cervical plexus block with 0.75% ropivacaine, whether administered before or after surgery, did not improve postoperative pain management compared to no block.

There were no significant differences in morphine requirements, pain intensity scores, or overall opioid consumption among the groups, indicating that this method of analgesia may not be effective for enhancing pain relief in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The bilateral superficial cervical plexus block with 0.75% ropivacaine administered before or after surgery does not prevent postoperative pain after total thyroidectomy. Herbland, A., Cantini, O., Reynier, P., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5828561/

Effectiveness of Bilateral Superficial Cervical Plexus Block as ...

Most trials showed significant reduction in pain intensity and severity of pain in patients for whom bilateral superficial cervical plexus block (BSCPB) was ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0007091217354764

Analgesic efficacy of bilateral superficial cervical plexus ...

BSCPB with ropivacaine or ropivaciane and clonidine was effective in reducing analgesic requirements after thyroid surgery.

3.

link.springer.com

link.springer.com/article/10.1007/s44254-023-00012-8

Effect of bilateral superficial cervical plexus block on ...

The use of BSCPB alleviates of postoperative pain, opioid requirement, and reduces incidence of postoperative nausea and vomiting in patients ...

4.

bmcresnotes.biomedcentral.com

bmcresnotes.biomedcentral.com/articles/10.1186/s13104-020-4907-7

The analgesic efficacy of bilateral superficial cervical plexus ...

Bilateral superficial cervical plexus block reduces postoperative nausea and vomiting and early postoperative pain after thyroidectomy. J ...

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digitalscholar.lsuhsc.edu

digitalscholar.lsuhsc.edu/cgi/viewcontent.cgi?article=4993&context=som_facpubs

Superficial Cervical Plexus Block for Postoperative Pain ...

Clinical evidence shows the block is effective in reducing acute postoperative pain after occipital craniotomy and diminishes opioid ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12371962/

Superficial Cervical Plexus Block for Postoperative Pain ...

Overall, current data support the SCPB as a dependable, well-tolerated, and clinically practical approach for managing post-craniotomy pain in ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12466003/

Effect of Bilateral Superficial Cervical Plexus Block on ...

The pooled analysis showed that BSCPB significantly reduced postoperative pain (p<0.05). The most significant reduction in pain was observed in the 6–24 hours ...