Bupivacaine for Postoperative Pain

(QoR-SCPB Trial)

Overseen By Anita M Jegarl, BS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Disqualifiers: Non-English, Repeat thyroid, Neck dissection, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether using bupivacaine, a local anesthetic, during thyroid surgery improves recovery by reducing pain. Participants will receive either a bupivacaine block or a saline placebo while under anesthesia, and researchers will compare the effects on recovery. The trial seeks individuals scheduled for thyroid surgery who can use a smartphone or computer to complete surveys. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that a superficial cervical plexus block with bupivacaine is likely to be safe?

Research has shown that bupivacaine is generally well-tolerated for managing post-surgical pain. In various studies, patients receiving bupivacaine did not experience more side effects than those receiving other treatments. For example, one study found that patients using bupivacaine managed their pain effectively without an increase in negative side effects. Bupivacaine is already widely used for post-surgical pain relief, indicating its safety.

While some studies have shown mixed results regarding its pain control efficacy, they do not report major safety concerns. This suggests that bupivacaine is safe to use, even if its effectiveness can vary depending on the type and length of surgery. Always discuss any concerns with a healthcare provider before joining a trial. ^{1 2 3 4}

Why are researchers excited about this trial's treatment?

Researchers are excited about Bupivacaine for postoperative pain because it offers a targeted approach for pain relief directly at the surgical site. Unlike standard oral pain medications, which affect the whole body, Bupivacaine is administered locally through a bilateral block, potentially reducing the need for systemic painkillers and minimizing side effects. It also works by blocking nerve signals in the area where it’s applied, providing more effective and focused pain control compared to traditional methods.

What evidence suggests that a superficial cervical plexus block with bupivacaine is effective for improving recovery after thyroid surgery?

Research shows that a specific numbing technique using bupivacaine can significantly reduce pain after thyroid surgery. In this trial, one group of participants will receive bupivacaine, which studies have found to help manage postoperative pain. This may result in less pain and a reduced need for pain medications afterward. However, some studies suggest its effectiveness may vary with the duration of the surgery. Overall, evidence supports that bupivacaine can improve recovery by reducing pain. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled for thyroid surgery, can access a smartphone or computer with internet, and are willing to follow the study's procedures. They must be classified as ASA Physical Status I-III, indicating they have mild to moderate systemic disease but not incapacitating.

Inclusion Criteria

I am scheduled for surgery on my thyroid.

You are willing to abide by all study requirements and able to participate for the entirety of the research.

My overall health is good to moderately impaired.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Assessment

Participants fill out an initial preoperative survey and are randomized to receive a superficial cervical plexus block with bupivacaine or saline placebo under anesthesia before surgery

1 day

1 visit (in-person)

Surgery and Immediate Postoperative Care

Participants undergo thyroid surgery and receive either bupivacaine or saline placebo. Postoperative care includes monitoring in the PACU with assessments for rescue antiemetics, analgesia, and opioid consumption

1 day

1 visit (in-person)

Postoperative Day 1 Assessment

Participants complete the Quality of Recovery-40 (QoR-40) questionnaire to assess recovery quality on the first postoperative day

1 day

1 visit (virtual)

Follow-up

Participants are monitored for any side effects and report on the quantity of analgesia used through postoperative day 1

2 days

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine
• Placebo
• Superficial Cervical Plexus Block

Trial Overview

The study tests if a superficial cervical plexus block using bupivacaine improves recovery quality after thyroidectomy compared to a placebo (saline). Participants will receive one of these treatments randomly before surgery and complete surveys preoperatively and on the first day post-surgery.

How Is the Trial Designed?

Group I: Bupivacaine Experimental Treatment 1 Intervention

Participants randomized to this arm will receive 10ml of 0.25% bupivacaine on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.

Group II: Placebo Placebo Group 1 Intervention

Participants randomized to this arm will receive 10ml of saline on each side of the bilateral block. This will be done after induction of general anesthesia and prior to start of surgery.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Published Research Related to This Trial

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]

In a study of 40 patients undergoing carotid endarterectomy, both superficial and combined cervical plexus blocks provided similar operative conditions, as indicated by the amount of supplemental lidocaine used during surgery.

Patient satisfaction was high for both techniques, and while the superficial block group experienced a longer median time to first analgesia, the differences in pain management outcomes were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of superficial versus combined (superficial and deep) cervical plexus block for carotid endarterectomy: a prospective, randomized study. Pandit, JJ., Bree, S., Dillon, P., et al.[2019]

In a double-blind randomized controlled trial involving 30 adult patients undergoing modified radical mastoidectomy, ultrasound-guided superficial cervical plexus block (SCPB) significantly reduced pain levels, as measured by the visual analogue scale (VAS), compared to those who did not receive the block.

Patients who received the SCPB also consumed less postoperative diclofenac for pain relief and reported no adverse effects, indicating that this method is both effective and safe for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of analgesic efficacy of superficial cervical plexus block in patients undergoing modified radical mastoidectomy: A randomised controlled trial. Deepika, V., Ahuja, V., Thapa, D., et al.[2022]

In a study of 240 patients undergoing neurosurgery, the use of a superficial cervical plexus block (SCPB) significantly reduced the incidence of postoperative cervicocephalic pain from 54% to 27%.

Patients who received SCPB not only experienced less pain but also reported milder pain intensity, indicating that SCPB is an effective preventive measure for this type of pain after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventive superficial cervical plexus block for postoperative cervicocephalic pain in neurosurgery. Niijima, K., Malis, LI.[2019]

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]

The study investigates the effectiveness of bilateral superficial cervical plexus block (SCPB) in improving postoperative recovery for 136 patients undergoing anterior cervical spine surgery, focusing on pain management and recovery quality.

By comparing SCPB with a placebo in a blinded, randomized trial, the research aims to provide clear evidence on whether SCPB significantly reduces opioid use, hospital stay length, and postoperative complications like nausea and pain intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral cervical plexus block for anterior cervical spine surgery: study protocol for a randomised placebo-controlled trial. Mulcahy, MJ., Elalingam, T., Jang, K., et al.[2022]

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 (BSCPB) significantly reduced the need for postoperative analgesics, as evidenced by lower tramadol consumption and fewer patients requiring rescue analgesics compared to the control group in a study of 60 patients undergoing thyroid surgery.

The use of BSCPB did not affect hemodynamic stability, indicating it is a safe and effective method to enhance pain management after thyroid surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Bilateral Superficial Cervical Plexus Block on Postoperative Analgesic Consumption in Patients Undergoing Thyroid Surgery. Ozgun, M., Hosten, T., Solak, M.[2022]

The superficial cervical plexus block (SCPB) is an effective regional anesthetic technique for surgeries in the submandibular area, neck, and ear lobe, providing valuable pain management for various conditions.

A case study demonstrated the successful use of SCPB in a patient undergoing surgery for a non-union of a mandibular fracture, highlighting its safety and efficacy without complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superficial Cervical Plexus Block in Selective Cases of Oral and Maxillofacial Surgery as an Alternative to General Anesthesia: A Case Presentation. Saripalli, RRK., Kasaraneni, S., Yadavilli, SS., et al.[2022]

Adding epinephrine (EPI) to bupivacaine (BUP) for superficial cervical plexus blockade (SCPB) significantly lowers plasma BUP concentrations, especially when using a lower concentration of BUP (0.25%).

The addition of EPI does not lead to increased heart rate or cardiac arrhythmias, indicating that it is a safe adjunct in this procedure without adverse cardiac effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma bupivacaine concentrations and effects of epinephrine after superficial cervical plexus blockade in patients undergoing carotid endarterectomy. Harwood, TN., Butterworth, JF., Colonna, DM., et al.[2019]

The study found that superficial cervical plexus block (SCPB) significantly reduced the need for intraoperative fentanyl and postoperative paracetamol in patients undergoing head and neck surgeries, indicating its effectiveness in providing analgesia.

Patients receiving SCPB experienced a longer duration of analgesia (approximately 1191 minutes) compared to those who only received systemic analgesia (about 122 minutes), with no significant complications reported, highlighting its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Analgesic Efficacy of Superficial Cervical Plexus Block for Head and Neck Surgeries: A Comparative Randomized Control Study. Patel, H., Shah, N., Syed, A., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7002882/

Effect of bupivacaine on postoperative pain and analgesics ...

Bupivacaine did not decrease pain and analgesics use. When surgery exceeded 40 minutes, bupivacaine use might be associated with less pain and less analgesics ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4970774/

Local bupivacaine for postoperative pain management in ...

Bilateral superficial cervical plexus block with bupivacaine has been shown to significantly reduce pain intensity in the postoperative period after thyroid ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06531603

Postoperative Analgesic Effectiveness of Bupivacaine With ...

Postoperative Analgesic Effectiveness of Bupivacaine With and Without Dexmedetomidine in Patients With Abdominal Surgery. ClinicalTrials.gov ID NCT06531603.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2949962325000105

Comparing intraoperative administration of long-acting ...

This study compared postoperative pain outcomes with LB versus MCs such as ropivacaine-epinephrine-clonidine-ketorolac, bupivacaine-epinephrine-dexamethasone, ...

5.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2777506

Standard vs Liposomal Bupivacaine for Postoperative Pain ...

Liposomal bupivacaine did not provide improved pain control and did not reduce adjunctive opioid use compared with conventional bupivacaine formulation over 3 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11094319/

The effect of bupivacaine on analgesia and safety in patients ...

Compared to the bupivacaine group, the bupivacaine-combined other drug group decreased the postoperative pain level at 6 h, 12 h, and 24 h while ...