Does the Common Practice of Adding Diluted Epinephrine in Tranverse

Status Active, not recruiting

Clinical Trial Summary

Locoregional anesthesia techniques are now widely recommended in perioperative multimodal analgesia protocols. The transverse abdominal plane block (TAP block), which consists of the injection of a local anesthetic in the vascular-nervous plane between the internal oblique muscle and the transverse abdominal muscle, has seen a significant increase in abdominal surgery with the advent of ultrasound guidance. Aimed at blocking the nerves destined to the antero-lateral abdominal wall, it has shown a benefit in several abdominopelvic surgeries with in particular a reduction of pain and a morphine sparing during the 24 postoperative hours as well as a shortening of the delay of resumption of the intestinal transit. Ropivacaine is the molecule of choice in transverse abdominal plane block because of its better safety profile among long-acting local anesthetics. Nevertheless, transverse abdominal plane block using ropivacaine has a risk of systemic toxicity, correlated to the peak systemic resorption of the local anesthetic, whose low incidence is probably underestimated in patients under general anesthesia. In this context, the addition of diluted adrenaline to the ropivacaine solution is a common practice in loco-regional anesthesia, including transverse abdominal plane block, to increase the duration of the peripheral block and reduce the peak plasma concentration of the local anesthetic. The objective of our study is to compare the pharmacokinetics of total and free ropivacaine administered in transverse abdominal plane block at the minimum effective dosage of 1 mg/kg without and with the addition of epinephrine at the concentration of 1:200000 (5 µg/mL) in patients scheduled for laparoscopic colectomy. The hypothesis is a significant reduction in the mean maximum concentration (Cmax) of total or free plasma ropivacaine in the adrenalized block transverse abdominal plane group. The practical applications in case of verification of the hypothesis are the provision of an argument to recommend the systematic adrenalization of the transverse abdominal plane block with ropivacaine in the interest of patient safety and the prospect of a downward reassessment of the minimum time to be respected between the administration of a transverse abdominal plane block with ropivacaine and that of another locoregional anesthesia.

Clinical Trial Description

n/a

Study Design

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Clinical Trial Details

NCT number	NCT04959123
Study type	Interventional
Source	Centre Hospitalier Universitaire de Nice
Contact
Status	Active, not recruiting
Phase	N/A
Start date	December 6, 2021
Completion date	January 6, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Does the Common Practice of Adding Diluted Epinephrine in Tranverse Abdominal Plan Block to Ropivacaine Significantly Decrease the Peak Systemic Resorption of Ropivacaine? — ROPIVADRE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms