Pain, PostoperativeCHIRTAPNCT04108221
Study Comparing Two Methods of TransversusAbdominis Plane
A study testing laparoscopy or laparotomy withTransversusAbdominis Plane Block in people with Pain, Postoperative, run by Institut Jean-Godinot at 1 site in France.
Trial summary
Interventional, randomised, prospective, multicentric study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- laparoscopy or laparotomy withTransversusAbdominis Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2019to 31 Mar 2022
- 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
- Patient over 18 years old
- Patient undergoing laparoscopic or laparotomic abdominal surgery at the investigator hospital.
- Patient mastering the French language
- Patient who received informed information about the study and signed a consent
- Patient affiliated to a social security scheme.
Who cannot join
- Patients with chronic pain
- Patients with opioid dependence
- Patients allergic to local anesthetic
- Patient who has not signed the consent of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Study of Noninferiority Comparing a TransversusAbdominis Plane Block Surgical (c-TAP Block) to the Ultrasound-guided Abdominis Plane Block Transversus (Us-TAP Block) in Postoperative Analgesia After Laparoscopy or Laparotomy
Interventional, randomised, prospective, multicentric study
Read the detailed description
Interventional, randomised, prospective, multicentric and single blind study
Primary objective :
demonstrate the equivalence of c-TAP Block to us-TAP Block in postoperative analgesia
Secondary objective :
- Assess the effectiveness of c-TAP block on us-TAP Block in the obese and/or malnourished patient subgroup
- Compare the running time of the c-TAP Block to the us-TAP Block
- Assess the safety of the c-TAP Block gesture in terms of trauma to the intraperitoneal organs by the injection needle two groups:
- Arm A : c-TAP Block performed by the surgeon
- Arm B : us-TAP Block performed by the anesthesist under ultrasound control
Schedule :
- Inclusions start at: 16/09/2019
- End date of inclusions: 31/03/2022
- End date of follow-up: 01/04/2022
- Study report: 30/09/2022
- Conditions
- Pain, Postoperative
- Being tested
- laparoscopy or laparotomy withTransversusAbdominis Plane Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopy or laparotomy withTransversusAbdominis Plane BlockProcedure or surgery
The US-TAP is performed by the anesthetist under ultrasound control after the end of the procedure of laparoscopy or laparotomy. Under sterile conditions, the anesthetist identifies the oblique abdominal muscles externally, obliquely internally and transversely by ultrasound. A 20 ml needle of 0.5% ropivacaine is injected.
The surgical TAP (c-TAP) block is performed by the surgeon at the end of the procedure of laparoscopy or laparotomy.The needle and the product used are identical to those of the us-TAP block. The positioning of the needle is in the plane of the fascia between the internal oblique muscle and the transverse muscle, identified by a significant loss of resistance.
| Study group | Role | What they receive |
|---|---|---|
| Arm A : c-TAP Block performed by surgeon | Experimental | c-TAP Block Block performed by surgeon Receives: Procedure: laparoscopy or laparotomy withTransversusAbdominis Plane Block |
| Arm B : us-TAP Block performed by anesthetist | Active comparator | us-TAP Block by anesthetist Receives: Procedure: laparoscopy or laparotomy withTransversusAbdominis Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution pain intensity scores, assessed by the numerical pain scale (EN), postoperative and need for systemic analgesics (intravenously or by mouth) during the 24 hours following the end of the procedure
Evolution pain intensity scores, assessed by the numerical pain scale (EN 1 up to 10)
Measured: 24 hours
Secondary outcomes (3)
Failure rate in the obese and / or malnourished patient subgroup
The failure will be defined as follows: a pain evaluated at> 4/10 on EN that requires intravenous or systemic analgesia
Measured: 24 hours
Time in minutes of each of the TAP Block techniques
The time will be quantified with a stopwatch. For the c-TAP, the stopwatch will be started as soon as the injection equipment of the locoregional anesthesia is received. For the us-TAP block, the stopwatch will be started after the end of the surgical procedure and as soon as the anesthetist starts to wash his hands to proceed with the injection
Measured: 24 hours
Occurrence of trauma to the intra-abdominal organs caused by the injection needle
number of traumas that have occurred
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 posted30 Sep 2019
- Study start16 Sep 2019
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Why it stopped: Principal Investigator condition
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Model description
- two arms : arm A : c-TAP Block performed by surgeon arm B : us-TAP Block performed by anesthetist
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Jean-Godinot
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Christophe EYMARD, PI, Principal investigator, Institut GODINOT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108221
- Sponsor's protocol ID
- 2019-A01444-53
- Acronym
- CHIRTAP
- Status last verified
- Jun 2021
- First submitted
- 26 Sep 2019
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Study of Noninferiority Comparing a TransversusAbdominis Plane Block Surgical (c-TAP Block) to the Ultrasound-guided Abdominis Plane Block Transversus (Us-TAP Block) in Postoperative Analgesia After Laparoscopy or Laparotomy
- ClinicalTrials.gov ID
- NCT04108221
- Acronym / sponsor ID
- CHIRTAP / 2019-A01444-53
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Principal Investigator condition
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Institut Jean-GodinotUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 30 Sep 2019 (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.
Interventional, randomised, prospective, multicentric study
Detailed description
Interventional, randomised, prospective, multicentric and single blind study
Primary objective :
demonstrate the equivalence of c-TAP Block to us-TAP Block in postoperative analgesia
Secondary objective :
- Assess the effectiveness of c-TAP block on us-TAP Block in the obese and/or malnourished patient subgroup
- Compare the running time of the c-TAP Block to the us-TAP Block
- Assess the safety of the c-TAP Block gesture in terms of trauma to the intraperitoneal organs by the injection needle two groups:
- Arm A : c-TAP Block performed by the surgeon
- Arm B : us-TAP Block performed by the anesthesist under ultrasound control
Schedule :
- Inclusions start at: 16/09/2019
- End date of inclusions: 31/03/2022
- End date of follow-up: 01/04/2022
- Study report: 30/09/2022
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- two arms : arm A : c-TAP Block performed by surgeon arm B : us-TAP Block performed by anesthetist
| Arm | Type | Receives |
|---|---|---|
| Arm A : c-TAP Block performed by surgeon | Experimental | Procedure: laparoscopy or laparotomy withTransversusAbdominis Plane Blockc-TAP Block Block performed by surgeon |
| Arm B : us-TAP Block performed by anesthetist | Active comparator | Procedure: laparoscopy or laparotomy withTransversusAbdominis Plane Blockus-TAP Block by anesthetist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient over 18 years old
- Patient undergoing laparoscopic or laparotomic abdominal surgery at the investigator hospital.
- Patient mastering the French language
- Patient who received informed information about the study and signed a consent
- Patient affiliated to a social security scheme.
Key exclusion criteria (4 listed)
- Patients with chronic pain
- Patients with opioid dependence
- Patients allergic to local anesthetic
- Patient who has not signed the consent of the study.
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 |
|---|---|---|
| laparoscopy or laparotomy withTransversusAbdominis Plane BlockThe US-TAP is performed by the anesthetist under ultrasound control after the end of the procedure of laparoscopy or laparotomy. Under sterile conditions, the anesthetist identifies the oblique abdominal muscles externally, obliquely internally and transversely by ultrasound. A 20 ml needle of 0.5% ropivacaine is injected. The surgical TAP (c-TAP) block is performed by the surgeon at the end of the procedure of laparoscopy or laparotomy.The needle and the product used are identical to those of the us-TAP block. The positioning of the needle is in the plane of the fascia between the internal oblique muscle and the transverse muscle, identified by a significant loss of resistance. | Procedure or surgery | Arm A : c-TAP Block performed by surgeon, Arm B : us-TAP Block performed by anesthetist |
Primary outcome
Evolution pain intensity scores, assessed by the numerical pain scale (EN), postoperative and need for systemic analgesics (intravenously or by mouth) during the 24 hours following the end of the procedure
Time frame: 24 hours
Evolution pain intensity scores, assessed by the numerical pain scale (EN 1 up to 10)
3 secondary outcomes
Failure rate in the obese and / or malnourished patient subgroup
Time frame: 24 hours
Time in minutes of each of the TAP Block techniques
Time frame: 24 hours
Occurrence of trauma to the intra-abdominal organs caused by the injection needle
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
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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.
Jean Christophe EYMARD, PI principal investigator
Institut GODINOT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopy or laparotomy withTransversusAbdominis Plane Block in people with Pain, Postoperative, run by Institut Jean-Godinot 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 5 inclusion and 4 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: paused, as of the sponsor's last update on 7 Apr 2022. 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?
Results are not available in the source record.
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?
Evolution pain intensity scores, assessed by the numerical pain scale (EN), postoperative and need for systemic analgesics (intravenously or by mouth) during the 24 hours following the end of the procedure (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2022.