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NCT Number: NCT04495504

Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery

The sternotomy site is the most painful site after cardiac surgery. Local infiltration of ropivacaine through the multihole catheters in the bilaterosternal position (BLS) after sternotomy significantly reduces pain at rest and during mobilization, reduces opioids consumption, decreases postoperative complications, improves patient comfort and satisfaction and reduced hospital costs. In this study our hypothesis is to test the efficacity of local anesthetic administration via the catheters in the BLS position placed before the surgical incision.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Clermont-Ferrand - Service de Chirurgie Cardio-Vasculaire

Clermont-Ferrand, Puy De Dôme, 63000, France

About this study

Goal of the study: Evaluation of the effectiveness of BLS technique on a composite endpoint (pain at rest, pain during patient mobilization and opioid consumption).

Open trial, therapeutic, prospective, monocentric. One group of patients who will benefits from the placement of two multihole catheters in BLS position:

  • The ropivacaine group (40 patients): placement by the surgeon of two catheters in BLS position before the surgical incision. Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter followed by a continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.
  • The control group (80 patients) from the two previous studies who underwent standard analgesia with PCA morphine.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who undergo scheduled cardiac surgery with sternotomy: aortic or mitral valve replacement, biological or mechanical, coronary bypass surgery
  • Age under 85 years
  • Patients who have given their consent according to the methods described in Title II of the book of the first Public Health Code
  • Possession of Social Security insurance.

Exclusion criteria

  • Emergency surgery
  • Approach by thoracotomy
  • Heart transplant
  • Aortic dissection
  • Redo surgery.
  • Pregnant women
  • Refusal of the protocol
  • Protected minors or adults
  • Pre-existing psychiatric pathology including known states of opioid addiction
  • Long-term opioid medication
  • Physical or intellectual inability to use a PCA
  • Severe heart failure (ejection fraction less than 40% or PAH > 50 mmHg)
  • Preoperative cardiogenic shock
  • Severe preoperative chronic or acute renal failure with a creatinine clearance of less than 30 mL / min according to Cockroft's formula
  • Known hypersensitivity to local anesthetics or to any component of the catheter
  • Known allergy or hypersensitivity to any of the study drugs or analgesia protocol (ropivacaine, paracetamol, opiates).

Treatment and study plan

Ropivacaine

Drug

Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter Continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.

Primary outcomes

  1. Pain evaluation

    Time frame: Day 2 postoperatively.

    The technique is considered as a fail if : pain rest > 3.5 /10 (0 = no pain; 10 maximum pain) or pain during mobilization > 3.5/10 (0 = no pain; 10 maximum pain)

  2. Opioid consumption

    Time frame: Day 2 postoperatively.

    The technique is considered as a fail if morphine consumption > 35 mg

Secondary outcomes

  1. ICU length of stay

    Time frame: Up to 6 months

    Days of ICU and hospital stay

  2. Hospital length of stay

    Time frame: Up to 6 months

    Days of ICU and hospital stay

  3. Patient satisfaction

    Time frame: Day 2 postoperatively.

    Patient satisfaction evaluation from the patient based on a simple Likert scale:

    0 = very bad; 1 = bad; 2 = medium; 3 = good; 4 = excellent.

  4. Postoperative nausea and vomiting

    Time frame: Day 1 and 2 postoperatively.

    assessed by the Wengritzky intensity scale (if total score > 50, the nausea and vomiting are clincally significant)

  5. Respiratory complications

    Time frame: Up to 6 months

    Occurrence of postoperative respiratory complications

  6. Cardiac complications

    Time frame: Up to 6 months

    Occurrence of postoperative cardiac complications

  7. Neurological complications

    Time frame: Up to 6 months

    Occurrence of postoperative neurological complications

  8. Renal,complications

    Time frame: Up to 6 months

    Occurrence of postoperative renal complications

  9. Infectious complications

    Time frame: Up to 6 months

    Occurrence of postoperative infectious complications

  10. Chronic pain evaluation

    Time frame: Assessed at the 6th postoperative month

    Chronic pain assessed at the 6th postoperative month by DN4 (Neuropathic Pain Diagnostic 4) score

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

The Effect of Continuous Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery

Acronym: Pre-BLS-Sterno

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 3, 2020
Registry last updated
Dec 5, 2022

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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