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Completed

NCT Number: NCT03482973

Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery

The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.

Specific Aim 1: To determine whether or not a PIFB with bupivacaine can reduce postoperative pain after cardiac surgery. This will be assessed through:

(Aim 1A) opioid consumption in the first 48 hours postoperatively (Aim 1B) patient self-reported pain scores during their hospital stay

Specific Aim 2: To estimate the effect size in order to obtain information that can be used to power future research on the use of regional modalities of analgesia for cardiac surgeries.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients 18 years of age or older
  • Undergoing cardiac surgery with sternotomy, limited to CABG, CABG+valve surgeries and isolated valve surgeries.

Exclusion criteria

  • Current participation in another interventional study
  • Preoperative LVEF < 30%
  • Use of mechanical circulatory support
  • Emergent procedures
  • Aortic surgeries, transplants ventricular assist device insertions, bentall, or grafts
  • Minimally invasive cardiac procedures or those with thoracotomy approach
  • Patients receiving other modalities of regional anesthesia like intrathecal morphine
  • Chronic opioid use for chronic pain conditions with tolerance (total daily dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year)
  • Current use of TCA, gabapentin, or pregabalin
  • Hypersensitivity to bupivacaine
  • Women who are pregnant or breastfeeding
  • Non English speaking

Treatment and study plan

Bupivacaine Group

Drug

20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).

Placebo

Other

20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).

Primary outcomes

  1. Opioid Consumption

    Time frame: 48 hours

    Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME).

Secondary outcomes

  1. Pain Scores

    Time frame: At 6-8 hourly intervals every day until discharge or 4 days

    Patient reported pain scores on a scale from 0-10 until discharge for the index admission. Where the minimum score is 0 and, the maximum score is 10. A score of 0 means no pain and the higher the score, the greater the pain intensity, with a score of 10 means worse imaginable pain. Pain scores recorded at 6-8 hourly intervals every day until discharge or 4 days, computed as an average pain score.

  2. ICU Length of Stay

    Time frame: Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days

    Total duration of stay in ICU for the index admission

  3. Hospital Length of Stay

    Time frame: Measured in days admitted in the hospital, an average of 5 days

    Their stay in the hospital for the index admission

  4. Number of Participants With Complications

    Time frame: 7 days post-op on an average

    This includes infection, hematoma, local anesthetic systemic toxicity directly related to the block or the drug used in the block

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2018
Registry last updated
Aug 3, 2020

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.

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