An interventional study of pharmacokinetic analysis in Bowel Disease, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Other
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.
963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 552 interventional studies indexed under Intestinal Diseases.
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Exclusion Criteria:
L. 1121-6: persons deprived of liberty by a judicial or administrative decision, persons hospitalized without consent and persons admitted to a health or social institution for purposes other than research; L. 1121-8: adults subject to a legal protection measure or unable to express their consent; L. 1122-1-2: persons in emergency situations who are unable to give prior consent.
- Patients participating in other research involving the human person.
Patients receive 0.5 mg/kg of actual weight of ropivacaine; the appropriate dose of ropivacaine is drawn from an ampoule of 0.5% ropivacaine, i.e., 5 mg/mL (example for a 75 kg individual: 7.5 mL in each syringe) In the "Ropivacaine only" group, there is no adrenaline, the syringe loaded with ropivacaine is supplemented to 20 mL with a 0.9% sodium chloride solution
Other: pharmacokinetic analysis
Patients receive 0.5 mg/kg of actual weight of ropivacaine; the appropriate dose of ropivacaine is drawn from an ampoule of 0.5% ropivacaine, i.e., 5 mg/mL (example for a 75 kg individual: 7.5 mLn each syringe) In the "ropivacaine + epinephrine" group, 0.1 mL of a 1 mg/mL ampoule of epinephrine is added to each syringe before making up to 20 mL (i.e., 100 µg of epinephrine for 20 mL of final solution, i.e., 5 µg/mL, i.e., 1 : 200000).
Other: pharmacokinetic analysis
Non-compartmental descriptive pharmacokinetic analysis (i.e. without the need for mathematical modelling), with determination of the pharmacokinetic parameters of interest either directly from the experimental points (Cmax, Tmax), or from simple mathematical equations (calculation of the area under the curve (AUC) by the trapezoidal method, calculation of the terminal slope of elimination)
Difference in mean peak concentrations (Cmax) of total and free plasma ropivacaine after transversus abdominis plane block between both groups
Difference between the mean peak concentrations (Cmax) of total and free plasma ropivacaine after transversus abdominis plane block 1 mg/kg of both transversus abdominis plane block-adrenaline+ and transversus abdominis plane block-adrenaline- groups (before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after transversus abdominis plane block).
Time frame: 240 minutes after transversus abdominis plane block
Difference in mean Tmax of total and free plasma ropivacaine between the two groups
Difference in mean Tmax (time to maximum concentration Cmax) of total and free plasma ropivacaine between the two groups transversus abdominis plane block-adrenaline+ and transversus abdominis plane block-adrenaline-
Time frame: 240 minutes after transversus abdominis plane block
Efficacy markers : pain visual analog scale
Collection of efficacy markers :pain visual analog scale. Score from 0 to 10. 0 being no pain and 10 being the maximum pain imaginable.
Time frame: 24 hours
Efficacy markers : morphine consumption
whether or not to use morphine during the 24 hours after surgery
Time frame: 24 hours
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice