SAP Block for Postoperative Pain

(Cardiac-SAP Trial)

Overseen By Jonathan Bailey

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Must not be taking: Opioids

Disqualifiers: Emergency surgery, ECMO, IABP, others

Compensation: Varies

Number of Visits: Unknown

Duration: 72 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a specific pain-relief method after heart surgery. Participants will receive either Ropivacaine, a numbing medication, or a placebo (Normal Saline Placebo) through a special block targeting pain near the chest area. The goal is to determine if this method manages pain better than standard care. The trial seeks adults who have undergone heart valve or artery surgery through the chest (sternum). As an unphased trial, participants can contribute to innovative research that may enhance post-surgical pain management.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on preoperative vasopressors or inotropes, you would not be eligible to participate.

What prior data suggests that the serratus anterior plane (SAP) block is safe for postoperative pain management?

Research has shown that ropivacaine is generally safe and effective for managing pain. One study compared two doses of ropivacaine and found it reduced pain after surgery. Ropivacaine is often chosen for its quick action and greater safety compared to similar drugs.

Another study found ropivacaine effective for nerve blocks, especially when combined with other medicines like dexmedetomidine. This combination is considered safe for patients. Additionally, research highlights ropivacaine's effectiveness in serratus anterior plane (SAP) blocks, which help manage pain after surgeries such as chest surgery.

Overall, these studies suggest that ropivacaine 0.2% is a safe option for pain relief, with few side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for postoperative pain involve systemic opioids or NSAIDs, which can have significant side effects and variable effectiveness. However, the serratus anterior plane (SAP) block using Ropivacaine 0.2% offers a targeted approach, delivering local anesthesia directly to the nerves in the chest wall area. This localized delivery can potentially reduce the need for systemic medications and their associated side effects, such as nausea, sedation, and dependency. Researchers are excited about this treatment because it may provide effective pain relief with fewer side effects, improving patient comfort and recovery after surgery.

What evidence suggests that the SAP block could be effective for postoperative pain?

Research has shown that Ropivacaine 0.2%, which participants in this trial may receive as part of the active serratus anterior plane (SAP) block, can effectively reduce post-surgical pain. In one study, patients who received SAP blocks with Ropivacaine experienced less pain shortly after treatment, and this relief persisted. Another study found Ropivacaine to be a reliable option for blocking nerve pain, managing pain without major side effects. Continuous use of Ropivacaine through small tubes for up to 72 hours has also demonstrated good results in controlling post-surgical pain. These findings suggest that Ropivacaine 0.2% could be beneficial for managing pain after heart surgery. Meanwhile, the placebo arm of this trial will use normal saline for comparison. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

Adults over 18 undergoing heart valve replacement/repair or bypass surgery via sternotomy can join. They must not be allergic to ropivacaine, have a BMI over 35, weigh less than 50 kg, use high-dose opioids, need emergency surgery, or have severe liver/kidney disease.

Inclusion Criteria

Undergoing valvular replacement/repair and/or coronary artery bypass grafting (CABG) via median sternotomy

Exclusion Criteria

An allergy to ropivacaine

You are scheduled to undergo circulatory arrest.

You have a body mass index (BMI) over 35.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Ropivacaine 0.2% or placebo via bilateral SAP block catheters for 72 hours postoperatively

72 hours

Continuous monitoring in cardiovascular intensive care unit

Follow-up

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

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Normal Saline Placebo
• Ropivacaine 0.2%

Trial Overview The trial is testing if the serratus anterior plane (SAP) block with Ropivacaine reduces pain after heart surgery compared to a saline placebo. Participants are randomly chosen to receive either the drug or placebo for three days post-surgery.

How Is the Trial Designed?

Group I: Active serratus anterior plane (SAP) block with Ropivacaine 0.2% Active Control 1 Intervention

Group II: Placebo serratus anterior plane (SAP) block with normal saline Placebo Group 1 Intervention

Normal Saline Placebo is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Normal Saline for:

• Fluid replacement
• Diluent for medications

Approved in Canada as 0.9% Sodium Chloride Solution for:

• Fluid replacement
• Diluent for medications

Approved in European Union as Saline Solution for:

• Fluid replacement
• Diluent for medications

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Jon Bailey

Lead Sponsor

Trials

2

Recruited

390+

Published Research Related to This Trial

In a study of 60 elective total knee arthroplasty patients, those who received a bupivacaine injection reported lower pain scores and used fewer narcotics in the first 24 hours post-surgery compared to the placebo group.

Although the bupivacaine group had a shorter discharge time from the postanesthesia care unit by 23 minutes, the differences in pain levels and narcotic consumption were not statistically significant when compared to the placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine bolus injection versus placebo for pain management following total knee arthroplasty. Browne, C., Copp, S., Reden, L., et al.[2022]

In a study of 38 patients undergoing spine stabilization surgery, continuous wound instillation of ropivacaine significantly reduced pain scores and the need for additional pain medication compared to standard IV morphine and ketorolac treatment.

The use of ropivacaine not only improved pain management but also resulted in less postoperative blood loss and a shorter hospital stay, with no observed toxic side effects, indicating its safety and efficacy for postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacokinetics and efficacy of ropivacaine continuous wound instillation after spine fusion surgery. Bianconi, M., Ferraro, L., Ricci, R., et al.[2022]

In a randomized trial with 41 patients undergoing elective hysterectomy, preoperative wound infiltration with bupivacaine 0.25% significantly reduced the total amount of postoperative buprenorphine needed compared to a placebo, indicating better pain management.

Patients receiving bupivacaine experienced a delay in the demand for additional analgesics, suggesting that bupivacaine effectively prolongs pain relief after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative wound infiltration with bupivacaine reduces early and late opioid requirement after hysterectomy. Hannibal, K., Galatius, H., Hansen, A., et al.[2019]

In a study of 20 patients undergoing abdominal surgery, infiltration of 0.25% bupivacaine significantly reduced postoperative pain scores and narcotic requirements compared to saline placebo, leading to better pain management in the post-anesthesia care unit (PACU).

Patients receiving bupivacaine also had improved oxygen saturation levels and were discharged from the PACU nearly an hour earlier, suggesting that using a long-acting local anesthetic can enhance recovery and potentially reduce pulmonary complications after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of incisional bupivacaine on postoperative narcotic requirements, oxygen saturation and length of stay in the post-anesthesia care unit. Partridge, BL., Stabile, BE.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12414255/

Comparison of 0.375% and 0.2% Ropivacaine for ... This study found no significant differences in postoperative pain, antiemetic requirements, or patient satisfaction between 0.375% and 0.2% ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39478458/

a randomized, double-blinded clinical trial Results: Finally, 74 patients were included in this study. Both groups exhibited significant pain reduction at one hour, with sustained pain ...

3. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-024-02769-2

a randomized, double-blinded clinical trial | BMC ... The findings of this study show that SAP block with dexmedetomidine is an effective and safe drug along with ropivacaine as a nerve-blocking agent in ...

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1438580/epub

Continuous serratus anterior plane block for postoperative ... ... 0.2% ropivacaine at 4 h intervals were utilized for postoperative pain management. The target for catheter placement was 72 h. FIGURE 1

5. apm.amegroups.org apm.amegroups.org/article/view/70150/html

Comparison of the effect of different volumes ropivacaine on ... Conclusions: The blocked dermatomes increased with increasing volume when 10, 20 and 30 mL ropivacaine was used for deep serratus anterior plane block. The ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10451145/

Comparative Efficacy of Serratus Anterior Plane Block ... SAPB was more effective than fentanyl in managing post-thoracotomy pain after MICS. Cortisol level was lower in the group that received SAPB.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149291824003291

Analgesic Effects and Pharmacokinetics of Ropivacaine at ... The use of 0.5% ropivacaine is recommended for SAPB to provide satisfactory perioperative analgesia. Abstract. Purpose. Investigate the analgesia effects and ...

8. cureus.com cureus.com/articles/357510-comparison-of-0375-and-02-ropivacaine-for-postoperative-analgesia-using-ultrasound-guided-pectoral-nerve-block-in-patients-undergoing-breast-cancer-surgery-a-randomized-controlled-study.pdf?email=

Comparison of 0.375% and 0.2% Ropivacaine for ... Ropivacaine, preferred for its safety and rapid onset than bupivacaine, is used in our study [17-19]. The primary objective was to compare the ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11666617/

Efficacy and safety of the serratus anterior plane block (SAP ... While this study highlights the efficacy of 30 ml of 0.23–0.33% ropivacaine for deep SAP block, further research is required to determine the effectiveness of ...