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

NCT ID: NCT04959123

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-06
• Study Completion Date: 2024-11-06

Brief 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.

Conditions

Bowel Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ropivacaine

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

Group Type: ACTIVE_COMPARATOR

pharmacokinetic analysis

Intervention Type: OTHER

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)

Ropivacaine + Epinephrine

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).

Group Type: EXPERIMENTAL

pharmacokinetic analysis

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults (≥ 18 years) scheduled for laparoscopic colectomy
• Physical status score ( American Society of Anesthesiologists) ≤ 3
• Non-obese (Body Mass Index < 30)
• Affiliated with a social security plan
• Having signed an informed consent
• Normal preoperative electrocardiogram including, but not limited to, a non-extended QTc interval (< 0.45 s in men and < 0.47 s in women).

Exclusion Criteria

• Presence of a contraindication for local anesthesia (injection site infection, coagulopathy)
• Known allergy to local anesthetics
• Known renal or hepatic insufficiency
• Pregnant or breastfeeding women
• Medical or psychiatric condition that makes communication difficult
• Chronic use of drugs that interfere with CYP1A2 metabolism of ropivacaine such as fluvoxamine (a potent CYP1A2 inhibitor)
• Chronic use of opioids or other treatments for chronic pain
• Chronic use of anti-arrhythmic drug(s) or drugs that can prolong the QTc space such as haloperidol, amiodarone, sotalol, etc.
• Protected persons defined in the following articles of the public health code:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Romain ROZIER

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

CHU de nice - Anesthésie Réanimation

Nice, Alpes-Maritimes, France

Countries

France

References

Rozier R, Le Guennec Y, Capdevila X, Le Louarn E, Balbo J, Lavrut T, Baque P, Perus O, Destere A, Maurice-Szamburski A. Impact of epinephrine on ropivacaine pharmacokinetics in TAP blocks: a randomized controlled trial. Reg Anesth Pain Med. 2025 Mar 17:rapm-2025-106500. doi: 10.1136/rapm-2025-106500. Online ahead of print.

Reference Type: DERIVED

PMID: 40096993 (View on PubMed)

Other Identifiers

20-PP-28

Identifier Type: -

Identifier Source: org_study_id