Skip to main content
OpenTrials
Completed

NCT Number: NCT05642416

Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT

The purpose of this prospective randomized controlled trial is to compare the effectiveness of two different delivery methods for postoperative pain management following cardiac surgery requiring median sternotomy: intermittent programmed LA bolus versus continuous LA infusion through ESP catheters. Effectiveness of analgesia will be assessed based on the subjects' NRS pain scores and opioid consumption. The primary outcome measure will be the patients' opioid consumption over the course of the 72 hours following surgery. Secondary outcomes measures that will be evaluated include NRS pain scores, intensive care unit (ICU) length of stay, and time to first dose of antiemetic in the postoperative period. It is hypothesized that the use of intermittent programmed LA boluses will provide better analgesia compared to continuous LA infusion through ESP catheters. The findings of this study will provide guidance regarding the optimal method of delivery for postoperative pain management in patients following cardiac surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Henry Ford Hospital

Detroit, Michigan, 48201, United States

About this study

The purpose of this prospective randomized controlled trial is to compare the effectiveness of two different delivery methods for postoperative pain management following cardiac surgery requiring median sternotomy: intermittent programmed LA bolus versus continuous LA infusion through ESP catheters. Effectiveness of analgesia will be assessed based on the subjects' NRS pain scores and opioid consumption. The primary outcome measure will be the patients' opioid consumption over the course of the 72 hours following surgery. Secondary outcomes measures that will be evaluated include NRS pain scores, intensive care unit (ICU) length of stay, and time to first dose of antiemetic in the postoperative period. It is hypothesized that the use of intermittent programmed LA boluses will provide better analgesia compared to continuous LA infusion through ESP catheters. The findings of this study will provide guidance regarding the optimal method of delivery for postoperative pain management in patients following cardiac surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-emergent elective cardiac surgery requiring median sternotomy for surgical exposure (i.e. CABG, aortic/mitral/tricuspid valve replacements) receiving ESP catheter preoperatively
  • Age 18-90

Exclusion criteria

  • Placement and/or existence of cardiac assist devices (LVAD, RVAD, Balloon Pump, Impella)
  • Neurocognitive dysfunction
  • Patients who expire before extubation
  • Non-English speaking
  • Daily opioid therapy prior to surgery
  • History of substance abuse
  • BMI > 45

Treatment and study plan

Continuous Infusion of ropivacaine

Drug

Continuous infusion of ropivacaine

Intermittent bolus of ropivacaine

Drug

Intermittent bolus of ropivacaine

Primary outcomes

  1. Opioid Consumption POD 1

    Time frame: 0-24 hours post-op

    Opioid consumption (MME) over the course of the first 24 hours following surgery

  2. Opioid Consumption POD 2

    Time frame: 24-48 hours post-op

    Opioid consumption (MME) over the course of the 48 hours following surgery

  3. Opioid Consumption POD 3

    Time frame: 48-72 hours post-op

    Opioid consumption (MME) over the course of the 48-72 hours following surgery

Secondary outcomes

  1. NRS Pain Score POD 1

    Time frame: 0-24 hrs post-op

    Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) in the first 24 hours post-op

  2. NRS Pain Score POD 2

    Time frame: 24-48 hrs post-op

    Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) on POD 2

  3. NRS Pain Score POD 3

    Time frame: 48-72 hrs post-op

    Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) during 48-72 hours post-op

  4. ICU Length of Stay

    Time frame: 7 days post-op

    Time from post-op to step-down from ICU

  5. Quality of Recovery 15 (QoR-15) Score POD 1

    Time frame: 0-24 hours post-op

    Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 1.

  6. Quality of Recovery 15 (QoR-15) Score POD 2

    Time frame: 24-48 hours post-op

    Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 2.

  7. Quality of Recovery 15 (QoR-15) Score POD 3

    Time frame: 48-72 hours post-op

    Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 3.

  8. Time to First Antiemetic

    Time frame: 0-200 hours post-op

    Time to first antiemetic post-op

  9. Time to First Bowel Movement

    Time frame: 0-72 hours post-op

    Time to first bowel movement post-op

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • Avanos Medical

Registry information

Official study title

Intermittent Bolus Versus Continuous Infusion Erector Spinae Catheters for Median Sternotomy Incisions: A Prospective Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 8, 2022
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.