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Erector Spinae Catheter for Open Heart Surgery

NCT03901612 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2023-08-21

No results posted yet for this study

Summary

Fast track to Extubation after cardiothoracic surgery is becoming more common after a number of reports showing it is safe and effective. However, It has introduced new challenges to pain control. Intubated patients require larger doses of opioids and benzodiazepines for comfort. In patients who are awake and spontaneously breathing, pain and agitation cannot be treated with lower doses.

Some centers still administer continuous infusions of opioid and benzodiazepines to extubated patients. These infusions may not be necessary and may even be harmful.

The recent pilot study (In press in Journal of cardio thoracic vascular anesthesia ) in our Vinmec hospitals performing open heart surgeries of peri-operative regional analgesia by Continuous Bilateral Erector Spinae Plane Blocks in adult showed that the pain relief was efficient and the requirement for opioids was zero in post-operative period.

It confirmed that the impact of regional anesthesia techniques on main procedure-specific postoperative outcomes is very important in opioids decreased use in the context of fast-track programs that are fully suggested after cardiac surgery.

In April 2017 we introduced the technique of ESP block for open heart surgeries in Adults and in pediatric. At the beginning we performed single shot block and the patients still needed during around 30 to 40 hours small doses of opioids to release their pain according to the evaluation by Comfort-B,FLACC VAS Scales. Since we are performing continuous peri-operative regional analgesia by Bilateral ESP catheters the requirement for additional opioids to release the pain is zero based on our practice of 480 ESP catheters for open heart surgeries.

We would like to compare the 2 analgesic techniques and analyze the post operative opioid consumption, the quality of recovery and the quality of life after the surgery.

Conditions

  • Post Operative Analgesia

Interventions

DRUG

Ropivacaine 0.2%

Continuous post operative regional analgesia

DRUG

saline 09%

Continuous post operative regional analgesia

Sponsors & Collaborators

  • Vinmec Healthcare System

    lead OTHER

Principal Investigators

  • sebastien bertin, md · VinMec HS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-05
Primary Completion
2023-08-14
Completion
2023-08-14

Countries

  • Vietnam

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 NCT03901612 on ClinicalTrials.gov