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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a pain relief method using a local anesthetic injected near the chest muscles for heart surgery patients. It aims to reduce pain by numbing chest nerves, helping patients recover more comfortably.

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 data supports the effectiveness of the drug Ropivacaine 0.2% for postoperative pain management?

Research shows that Ropivacaine 0.2% significantly reduces pain compared to saline, as seen in a study where patients using Ropivacaine had much lower pain scores after shoulder surgery than those using saline. ^{1 2 3 4 5}

Is the SAP Block for Postoperative Pain treatment safe for humans?

The studies show that using saline solutions, like normal saline or 0.9% sodium chloride, is generally safe for humans, as no significant side effects were reported. Ropivacaine, when used in controlled amounts, also did not show harmful effects in the studies, indicating it is generally safe for human use. ^{1 3 6 7 8}

How does the SAP Block treatment with Ropivacaine 0.2% differ from other postoperative pain treatments?

The SAP Block treatment using Ropivacaine 0.2% is unique because it involves a continuous infusion of a local anesthetic directly into the surgical site, which can provide effective pain relief with potentially fewer side effects compared to systemic narcotics. This method allows for targeted pain management, reducing the need for additional pain medications and potentially shortening hospital stays. ^{1 3 6 9 10}

Eligibility Criteria

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

Adult (aged >18 years) patients at time of screening

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

References

1. England 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. [2019]

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

Moderate-to-severe pain after knee arthroscopy is relieved by intraarticular saline: a randomized controlled trial. [2022]

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

Bupivacaine bolus injection versus placebo for pain management following total knee arthroplasty. [2022]

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

Preoperative wound infiltration with bupivacaine reduces early and late opioid requirement after hysterectomy. [2019]

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

Continuous interscalene brachial plexus block for postoperative pain control at home: a randomized, double-blinded, placebo-controlled study. [2022]

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

Postoperative pain relief using intermittent injections of 0.5% ropivacaine through a catheter after laparoscopic cholecystectomy. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

[Prospective study on the effect of various preparations of 1% mepivacaine solutions without preservatives]. [2015]

8. England pubmed.ncbi.nlm.nih.gov

A prospective double-blind randomized controlled trial of the effect of topical bupivacaine on post-operative pain in bilateral nasal surgery with bilateral nasal packs inserted. [2013]

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

The pharmacokinetics and efficacy of ropivacaine continuous wound instillation after spine fusion surgery. [2022]

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

Comparison of Effects of Hemostatic Gelatin Sponge Impregnated with Ropivacaine versus Normal Saline Applied on the Transverse Process of the Operated Vertebrae on Postoperative Pain in Patients Undergoing Spinal Instrumentation Surgery: A Randomized Clinical Trial. [2020]