Continuous Serratus Anterior Blockade for Sternotomy Analgesia Following Cardiac Surgery: A Pilot Feasibility Study. (Cardiac-SAP)

NCT04648774 NA ACTIVE_NOT_RECRUITING

This is a pilot study to assess the feasibility of a full study. The purpose is to assess the analgesic effectiveness of the serratus anterior plane (SAP) block following cardiac surgery. Patients will be randomized to receive either Ropivacaine 0.2% or placebo via bilateral SAP block catheters for 72 hours postoperatively.

Details

Lead sponsor	Nova Scotia Health Authority
Phase	NA
Status	ACTIVE_NOT_RECRUITING
Enrolment	50
Start date	2021-07-22
Completion	2026-08

Conditions

• Postoperative Pain
• Opioid Use
• Quality of Life

Interventions

• Serratus anterior plane (SAP) block
• Normal saline placebo

Primary outcomes

• Recruitment rate — 1 month
  Number of patients recruited to the study
• Adherence rate — Until measurement of quality of recovery at 72 hours
  The number of patients with no protocol violations
• Primary outcome measurement rate (quality of recovery 15 index) — 72 hours
  The number of patients completing the quality of recovery 15 (QoR-15) index
• Combined major block-related adverse event rate — Until block catheter is removed at 72 hours
  The number of patients experiencing a major block-related adverse event including pneumothorax, local anesthetic systemic toxicity (LAST) or allergic reaction.

Countries

Canada