50 Participants Needed

SAP Block for Postoperative Pain

(Cardiac-SAP Trial)

JB
Overseen ByJonathan Bailey
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Nova Scotia Health Authority

What You Need to Know Before You Apply

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.

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.12345

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.13467

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.348910

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.
See 10 more

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?
2Treatment groups
Active Control
Placebo Group
Group I: Active serratus anterior plane (SAP) block with Ropivacaine 0.2%Active Control1 Intervention
Group II: Placebo serratus anterior plane (SAP) block with normal salinePlacebo Group1 Intervention

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

πŸ‡ΊπŸ‡Έ
Approved in United States as Normal Saline for:
πŸ‡¨πŸ‡¦
Approved in Canada as 0.9% Sodium Chloride Solution for:
πŸ‡ͺπŸ‡Ί
Approved in European Union as Saline Solution for:

Find a Clinic Near You

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

Citations

The effects of incisional bupivacaine on postoperative narcotic requirements, oxygen saturation and length of stay in the post-anesthesia care unit. [2019]
Moderate-to-severe pain after knee arthroscopy is relieved by intraarticular saline: a randomized controlled trial. [2022]
Bupivacaine bolus injection versus placebo for pain management following total knee arthroplasty. [2022]
Preoperative wound infiltration with bupivacaine reduces early and late opioid requirement after hysterectomy. [2019]
Continuous interscalene brachial plexus block for postoperative pain control at home: a randomized, double-blinded, placebo-controlled study. [2022]
Postoperative pain relief using intermittent injections of 0.5% ropivacaine through a catheter after laparoscopic cholecystectomy. [2022]
[Prospective study on the effect of various preparations of 1% mepivacaine solutions without preservatives]. [2015]
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]
The pharmacokinetics and efficacy of ropivacaine continuous wound instillation after spine fusion surgery. [2022]
10.United Statespubmed.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]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceΒ·Privacy PolicyΒ·CookiesΒ·Security