Institut Mutualiste montsouris
Paris, 75014, France
NCT Number: NCT04546113
The purpose of this randomized double-blind study is to compare the analgesic efficacy of the bilateral Erector Spinae Plane (ESP) block versus the bilateral Thoracic Paravertebral block (TPVB), by ultrasound-guided single injection in patients who underwent sternotomy for cardiac surgery.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Paris, 75014, France
Cardiac surgery causes moderate to severe postoperative pain during the first 24 - 48 post-operative hours. This pain is greatly increased by mobilization (respiratory physiotherapy) and leads to the consumption of morphine.
Appropriate analgesia, along with a reduction in morphine consumption are important factors in reducing morbidity after cardiac surgery and allow better postoperative rehabilitation.
Recently, the concept of multimodal analgesia has become established, which corresponds to ensuring optimal analgesia through the use of non-morphine drugs associated with locoregional analgesia.
During cardiac surgery, Paravertebral block (TPVB) technique is the first line of reference in our establishment. Lately, a new approach of blocking the intercostal nerves called Erector Spinae Plane block (ESP) has been discovered. It is a technique that seems simpler and safer than TPVB.
Until now, the analgesic efficacy of the ESP block compared to TPVB after cardiac surgery by sternotomy has never been studied.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bilateral injection of 20 ml of Ropivacaine 3,75 mg/ml/side
Bilateral injection of 20 ml of Ropivacaine 3,75 mg/ml/side
Time frame: 6 hours from the end of the surgery
Pain assessment measured with Visual Analogue Scale (VAS) between 0 (no pain, best outcome) and 10 (worst possible pain, worst outcome) at mobility, (respiratory effort during peak flow meter measurement)
Time frame: During the surgery
Based on hemodynamic response to incision and sternotomy (increase in heart rate, measured in beats per minute (bpm)
Time frame: During the surgery
Based on variations in the ANI (Anti Nociceptive Index) value (scale from 0 (maximum of nociception) to 100 (complete analgesia))
Time frame: During the surgery
Based on hemodynamic response to incision and sternotomy (increase in blood pressure, measured in mmHg). Blood pressure numbers of less than 120/80 mm Hg are considered within the normal range.
Time frame: During the surgery
Intraoperative sufentanil consumption (at the discretion of physicians based on haemodynamic variations and ANI values). Measured in ng/ml.
Time frame: 3, 6, 12, 24, 48 hours from the end of the surgery
Pain assessment measured with Visual Analogue Scale between 0 (no pain, best outcome) and 10 (worst possible pain and and worst outcome) at mobility, (respiratory effort during peak flow meter measurement)
Time frame: 3, 6, 12, 24, 48 hours from the end of the surgery
Morphine PCA consumption, measured in mg/h.
Time frame: 3, 6, 12, 24, 48 hours from the end of the surgery
Incidence of post operative nausea, vomiting and sedation
Time frame: 48 hours from the end of the surgery
Pneumothorax, major hematoma, sympathetic block
Institut Mutualiste Montsouris
Other
Erector Spinae Plane Block Versus Paravertebral Block for Analgesic Outcomes After Cardiac Surgery (PEPS): a Prospective Randomized Comparative Study.
Acronym: PEPS
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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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