Bowel DiseaseROPIVADRENCT04959123
Does the Common Practice of Adding Diluted Epinephrine in Tranverse Abdominal Plan Block to Ropivacaine Significantly Decrease the Peak Systemic Resorption of Ropivacaine?
A study testing pharmacokinetic analysis in people with Bowel Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Disease
- What is being tested?
- pharmacokinetic analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 6 Dec 2021to 6 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 11Show fewer
- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- pharmacokinetic analysis
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacokinetic analysisOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Active comparator | 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 Receives: Other: pharmacokinetic analysis |
| Ropivacaine + Epinephrine | Experimental | 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). Receives: Other: pharmacokinetic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 240 minutes after transversus abdominis plane block
Secondary outcomes (3)
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-
Measured: 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.
Measured: 24 hours
Efficacy markers : morphine consumption
whether or not to use morphine during the 24 hours after surgery
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start6 Dec 2021
- Primary completion19 Nov 2023
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain ROZIER, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959123
- Sponsor's protocol ID
- 20-PP-28
- Acronym
- ROPIVADRE
- Status last verified
- Mar 2026
- First submitted
- 28 Jun 2021
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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. 2026 Aug 5;51(8):911-917. doi: 10.1136/rapm-2025-106500.
PubMed 40096993
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Common Practice of Adding Diluted Epinephrine in Tranverse Abdominal Plan Block to Ropivacaine Significantly Decrease the Peak Systemic Resorption of Ropivacaine?
- ClinicalTrials.gov ID
- NCT04959123
- Acronym / sponsor ID
- ROPIVADRE / 20-PP-28
- Conditions
- Bowel Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 19 Nov 2023 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Active comparator | Other: pharmacokinetic analysisPatients 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 |
| Ropivacaine + Epinephrine | Experimental | Other: pharmacokinetic analysisPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharmacokinetic analysisNon-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) | Other | Ropivacaine, Ropivacaine + Epinephrine |
Primary outcome
Difference in mean peak concentrations (Cmax) of total and free plasma ropivacaine after transversus abdominis plane block between both groups
Time frame: 240 minutes after transversus abdominis plane block
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).
3 secondary outcomes
Difference in mean Tmax of total and free plasma ropivacaine between the two groups
Time frame: 240 minutes after transversus abdominis plane block
Efficacy markers : pain visual analog scale
Time frame: 24 hours
Efficacy markers : morphine consumption
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Results publication: PubMed 40096993Rozier 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. 2026 Aug 5;51(8):911-917. doi: 10.1136/rapm-2025-106500.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain ROZIER principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmacokinetic analysis in people with Bowel Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean peak concentrations (Cmax) of total and free plasma ropivacaine after transversus abdominis plane block between both groups (time frame: 240 minutes after transversus abdominis plane block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04959123, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.