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Continuous Serratus Anterior Blockade for Sternotomy

NCT04648774 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-08-23

No results posted yet for this study

Summary

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.

Conditions

  • Postoperative Pain
  • Opioid Use
  • Quality of Life

Interventions

PROCEDURE

Serratus anterior plane (SAP) block

With the patient in supine position, an ultrasound transducer will be used to find the 4th rib in the mid-axillary line. A 17g touhy needle will be introduced in-plane in an inferior to superior direction until its tip rests between the serratus anterior muscle and the 4th rib or the 3rd external intercostal muscle. A bolus of study drug 10ml (either ropivacaine 0.2% or normal saline) will be delivered though the needle. A 18g multiholed catheter will be inserted and secured to the patients' skin with adhesive dressings. A further 10ml of study drug will be administered through the catheter. The same procedure will be followed on the contralateral side. The study drug will be administered by programmed intermittent bolus (PIB) 10ml every 2 hours to each side in a staggered, alternating fashion. The PIB study drug will to be continued for 72 hours post-insertion.

PROCEDURE

Normal saline placebo

Patients in both groups will receive the standard of care analgesic medications in the cardiovascular intensive care unit and the ward.

Sponsors & Collaborators

  • Nova Scotia Health Authority

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-22
Primary Completion
2026-02-02
Completion
2026-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04648774 on ClinicalTrials.gov