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Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT

Sponsor
Henry Ford Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT05642416
Collaborator
Avanos Medical (Other)
240
Enrollment
1
Location
2
Arms
14.5
Anticipated Duration (Months)
16.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Continuous Infusion of ropivacaine
  • Drug: Intermittent bolus of ropivacaine
 Phase 4

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients will be randomized to one of two treatment groups (one with continuous infusion of drug and the other with bolus via ESP catheter)Patients will be randomized to one of two treatment groups (one with continuous infusion of drug and the other with bolus via ESP catheter)
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
The only people who will know the treatment arm that has been assigned to the participant are the research coordinator who randomized them and the regional anesthesia team. The patient, nursing team, and research coordinator performing outcomes assessments will all be blinded to the treatment group.
Primary Purpose:
Treatment
Official Title:
Intermittent Bolus Versus Continuous Infusion Erector Spinae Catheters for Median Sternotomy Incisions: A Prospective Randomized Controlled Trial
Actual Study Start Date :
Oct 15, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Continuous Infusion

Will receive a continuous infusion of pain medication (0.2% ropivacaine at a rate of 10mL per hour- 5mL per side per hour) via erector spinae plane (ESP) catheter for their postoperative pain following median sternotomy incision.

Drug: Continuous Infusion of ropivacaine
Continuous infusion of ropivacaine
Experimental: Intermittent Bolus

Will receive intermittent boluses of pain medication (30mL bolus of 0.2% ropivacaine every three hours) via erector spinae plane (ESP) catheter for their postoperative pain following median sternotomy incision.

Drug: Intermittent bolus of ropivacaine
Intermittent bolus of ropivacaine

Outcome Measures

Primary Outcome Measures

  1. Opioid consumption [72 hours post-op]

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

Secondary Outcome Measures

  1. NRS Pain Scores (10) [72 post-op]

    Numeric rating scale for pain (rated 0=no pain through 10= worst imaginable pain)

  2. ICU length of stay [72 hours post-op]

    Time from post-op to step-down from ICU

  3. Quality of Recovery 15 (QoR-15) score [72 hours post-op]

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

  4. Time to first antiemetic [72 hours post-op]

    Time to first antiemetic

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Henry Ford Hospital Detroit Michigan United States 48201

Sponsors and Collaborators

  • Henry Ford Health System
  • Avanos Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Patrick Forrest, Staff Anesthesiologist, Division Head of Regional Anesthesia, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT05642416
Other Study ID Numbers:
  • 15737
First Posted:
Dec 8, 2022
Last Update Posted:
Dec 8, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Pain, Postoperative
Ropivacaine

Study Results

No Results Posted as of Dec 8, 2022