Bupivacaine for Postoperative Pain

(QoR-SCPB Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Yale University

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

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn whether a superficial cervical plexus block improves quality of recovery after thyroid surgery. Investigators will compare a superficial cervical plexus block with bupivacaine compared to an identical procedure performed saline placebo to see if there is a difference in quality of recovery on the first postoperative day. The main question to answer is: • Does a superficial cervical plexus block with bupivacaine compared to placebo improve quality of recovery in patients having thyroid surgery. Participants will: * Fill out an initial preoperative survey * Be randomized to receive a superficial cervical plexus block with bupivacaine or saline placebo while under anesthesia before the surgery starts * Fill out a survey about recovery on the first day after surgery

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.

What data supports the effectiveness of this treatment for postoperative pain?

Research shows that using a superficial cervical plexus block (SCPB) with bupivacaine can improve pain relief after surgeries like thyroidectomy and anterior cervical discectomy, suggesting it may be effective for managing postoperative pain. ^{1 2 3 4 5}

Is bupivacaine safe for use in humans?

Bupivacaine, used in procedures like the superficial cervical plexus block, generally shows minimal side effects and is considered safe for managing postoperative pain, though it can cause changes in heart rate when combined with epinephrine. ^{1 5 6 7 8}

How does bupivacaine differ from other drugs for postoperative pain?

Bupivacaine is unique because it is often used in a superficial cervical plexus block, which is a type of regional anesthesia that targets nerves in the neck to reduce pain after surgeries like thyroidectomy. This method can provide effective pain relief with potentially fewer systemic side effects compared to general anesthesia or systemic pain medications. ^{1 2 9 10 11}

Research Team

Eligibility Criteria

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.

I am 18 years old or older.

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

Trial Timeline

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

Treatment Details

Interventions

• Bupivacaine (Other)
• Placebo (Other)
• Superficial Cervical Plexus Block (Procedure)

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.

Participant Groups

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+

Nancy J. Brown

Yale University

Chief Medical Officer since 2020

MD from Yale School of Medicine

Peter Salovey

Yale University

Chief Executive Officer since 2013

PhD in Psychology from Yale University

Findings from Research

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]

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]

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]

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 (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]

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]

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]

References

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

Evaluating the Analgesic Efficacy of Superficial Cervical Plexus Block for Head and Neck Surgeries: A Comparative Randomized Control Study. [2023]

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

Effect of superficial cervical plexus block on postoperative quality of recovery after anterior cervical discectomy and fusion: a randomized controlled trial. [2015]

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

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

5. India pubmed.ncbi.nlm.nih.gov

Evaluation of analgesic efficacy of superficial cervical plexus block in patients undergoing modified radical mastoidectomy: A randomised controlled trial. [2022]

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

Plasma bupivacaine concentrations and effects of epinephrine after superficial cervical plexus blockade in patients undergoing carotid endarterectomy. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Bilateral cervical plexus block for anterior cervical spine surgery: study protocol for a randomised placebo-controlled trial. [2022]

8. Japan pubmed.ncbi.nlm.nih.gov

Preventive superficial cervical plexus block for postoperative cervicocephalic pain in neurosurgery. [2019]

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

Effect of Bilateral Superficial Cervical Plexus Block on Postoperative Analgesic Consumption in Patients Undergoing Thyroid Surgery. [2022]

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

A comparison of superficial versus combined (superficial and deep) cervical plexus block for carotid endarterectomy: a prospective, randomized study. [2019]

11. United States 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. [2022]