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Tiny additive could cut risk in abdominal pain blocks

NCT ID NCT04959123

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether adding diluted epinephrine to the numbing drug ropivacaine during a TAP block (a pain block for abdominal surgery) lowers the peak amount of ropivacaine in the blood. Forty adults having laparoscopic colectomy received either ropivacaine alone or with epinephrine. The goal was to see if epinephrine reduces the risk of drug toxicity. Results may help make this common pain block safer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ropivacaine with or without epinephrine
What this could lead to
If adding epinephrine significantly lowers peak ropivacaine levels, it could lead to safer pain-blocking procedures for abdominal surgeries.
What could go wrong
This is a small, completed pharmacokinetic study (40 people) that only measures drug levels, not clinical outcomes. Results may not change practice or apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Started

Dec 2021

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CHU de nice - Anesthésie Réanimation

    Nice, Alpes-Maritimes, 06001, France

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