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 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.

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.

Is the cervical plexus block safe for humans?

Research on cervical plexus blocks, including bilateral superficial cervical plexus blocks, suggests they are generally safe for humans, with few side effects reported in studies involving thyroid and spine surgeries. ^{1 2 3 4 5}

How does the treatment of Bilateral Superficial Cervical Plexus Blocks and Local Wound Infiltration differ from other treatments for postoperative pain?

This treatment is unique because it combines a bilateral superficial cervical plexus block, which targets specific nerves in the neck to provide localized pain relief, with local wound infiltration, offering a dual approach to managing postoperative pain. Unlike some other treatments, it focuses on site-specific pain relief with minimal side effects, enhancing recovery quality. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Bilateral Superficial Cervical Plexus Blocks and Local Wound Infiltration for postoperative pain?

Research shows that bilateral superficial cervical plexus blocks, when used with general anesthesia, can help manage pain after thyroid surgery, although some studies found no significant reduction in pain medication needs. This suggests that while the treatment may not always reduce the need for additional pain relief, it could still offer some benefits in managing postoperative pain. ^{1 2 3 5 6}

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]

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]

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]

Citations

1. United States 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. [2015]

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Does bilateral superficial cervical plexus block decrease analgesic requirement after thyroid surgery? [2022]

4. England pubmed.ncbi.nlm.nih.gov

Comparison of analgesic efficacy between bilateral superficial and combined (superficial and deep) cervical plexus block administered before thyroid surgery. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Bilateral superficial cervical plexus block combined with general anesthesia administered in thyroid operations. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Superficial vs combined cervical plexus block for carotid endarterectomy: a prospective, randomized study. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Superficial and deep cervical plexus block: technical considerations. [2022]