SurgeryTapasNCT03971513
Trans Abdominal Plane Block (TAP Block) in Surgery of Stoma Reversal and Its Effect on Post Operative Recovery: a Prospective, Randomized, Muticenter Study
A study testing Trans abdominal plane in people with Surgery and Stoma Ileostomy, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial summary
The primary purpose of TAPAS study is to demonstrate the superiority of analgesic effect of trans abdominal plane block (TAP block) performed at the beginning of stoma reversal, compared to standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Stoma Ileostomy
- What is being tested?
- Trans abdominal plane
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Jun 2019to 17 Apr 2023
- 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
- Age > 18 years old
- Patients operated of a scheduled stoma reversal surgery
- Patients having given consent in the mannen described in Article L1122-1-1 of the Public Health Code
- Patients affiliated with asocial security regimen or beneficiary of such a regimen
Who cannot join
- Renal insufficiency (ie glomerular filtration output < 35 ml/min)
- Patients with chronic inflammatory bowel disease
- Body mass index > 35 kg/m2
- Chronic pain with opiates
- Patients with cognitive troubles
- Coagulation disorders (platelets count < 80G/L, PT< 50%, V factor < 50%)
Show all 9Show fewer
- Pregnancy
- Breastfeeding
- Local anesthesics (amide class) allergy
Trial locations and contacts
2 sites in 1 country.
About this study
The primary purpose of TAPAS study is to demonstrate the superiority of analgesic effect of trans abdominal plane block (TAP block) performed at the beginning of stoma reversal, compared to standard of care.
The hypothesize is that a TAP block performed at the beginning of surgery of stoma reversal would improve patient's satisfaction (evaluated by Quo-r40 questionnaire), would reduce the incidence of post operative pain, time spent in recovery room, and reduce hospitalisation time
Read the detailed description
The patient will arrive in the department the day before the surgical intervention (D-1). During this preoperative visit (D-1), the investigator
- will preselect potentially eligible patients
- will offer to participate to this study
- will give the notice form to the patients
- will present the research: objectives, benefits and constraints for the patients
The intervention day (D0):
The investigator will collect the signed consent form after having ascertained the understanding of the notice form by the patient and checking the inclusion and non-inclusion criteria.
The randomization will be done via the eCRF module (allocation group and number) and the preoperative data registration in the eCRF.
Surgical Intervention (D1):
All patients will receive standard anaesthesia using sufentanyl, propopol, cisatracurium and sevoflurane. Prevention of nausea and vomiting is performing using Apfel score. Anti microbial prophylaxis is performed according recommendations.
All patients will receive post operative multimodal analgesia using, acetaminophene, ketaminophene (if no contra indication), nefopam, and morphine if NRS (numerating rating scale) > 3 At the end of the surgery, patients in the experimental group will receive a ultrasound guided trans abdominal plane block with 20 ml of 5 mg/mg of ropivacaine. Patients in the control group will not receive the block
- Conditions
- Surgery, Stoma Ileostomy
- Being tested
- Trans abdominal plane
- Keywords
- Prospective randomized pilot study, Trans abdominal plane block, Quo R 40 score, Post operative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans abdominal planeProcedure or surgery
Trans abdominal plane block is performed with ultra sound guidance.
- - The high frequency probe is placed right to the umbilicus, and slips laterally to the side to block. It allows showing the three belts of larges muscles of abdomen (External Oblicum, internal oblicum, and transversal of the abdomen).
- - When the needle is visualised in the plan separating the muscle internal oblicum and transversal of the abdomen, 20 ml of ropivacaïne 5mg/ml are injected after aspiration test. If in doubt, hydro localisation car be realised.
| Study group | Role | What they receive |
|---|---|---|
| usual practice | No intervention | Control group (usual practice): patients receiving a general anaesthesia with propofol, sufentanyl and cisatracurium for the induction, and sevoflurane, sufentanyl and cisatracurium for the maintenance. Patients receiving a multimodal intravenous analgesia, with acetaminophen, ketoprophen, nefopam and morphine. if necessary. Antimicrobial prophylaxis is performed according to recommendations |
| TAP block | Experimental | In addition of usual practice, patients receiving a TAP block at the beginning of the surgery Receives: Procedure: Trans abdominal plane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quo 40 score
Once the patient is transferred in post operative surgical service, assessment of the primary outcome will be done by the physician in charge of the patient. Quo 40 score is a postoperative recovery score above 200 points validated by Myles et al in 2001.
Measured: Day 1 (
Secondary outcomes (5)
NRS (Numeric rating scale)
Numerating rating score variating from 0 to 10, done by nurses in operating room and in post operative surgical service
Measured: Day 1 : At the entrance of recovery room
NRS (Numeric rating scale)
Numerating rating score variating from 0 to 10, done by nurses in operating room and in post operative surgical service
Measured: Day 1
NRS (Numeric rating scale)
Numerating rating score variating from 0 to 10, done by nurses in operating room and in post operative surgical service
Measured: Day 2
Quo 40 score
Once the patient is transferred in post operative surgical service, assessment of the primary outcome will be done by the physician in charge of the patient. Quo 40 score is a postoperative recovery score above 200 points validated by Myles et al in 2001.
Measured: Day 15
Time spent in recovery room
Assessment of time spent in recovery room (ie: entrance in recovery room until Aldrede score is >9) performed by nurses (Until 6 hours).
Measured: At the output of recovery room ie until 6 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start17 Jun 2019
- Primary completion17 Apr 2023
- Study completion17 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model description: Randomization in 2 groups * Control group (usual practice): patients receiving a general anaesthesia with propofol, sufentanyl and cisatracurium for the induction, and sevoflurane, sufentanyl and cisatracurium for the maintenance. Patients receiving a multimodal intravenous analgesia, with acetaminophen, ketoprophen, nefopam and morphine if necessary Antimicrobial prophylaxis is performed according to recommendations. * Experimental group: patients receiving a general anaesthesia with propofol, sufentanyl and cisatracurium for the induction, and sevoflurane, sufentanyl and cisatracurium for the maintenance. Patients receiving a multimodal intravenous analgesia, with acetaminophen, ketoprophen, nefopan and morphine if necessary Antimicrobial prophylaxis is performed according to recommendations. In this group, a trans abdominal plane block, using 20 ml of ropivacaine 5 mg/ml is performed at the beginning of surgery, using ultrasound guidance.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Vignaud, Principal investigator, CHU Clermont-Ferrand.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971513
- Sponsor's protocol ID
- RBHP 2019 VIGNAUD - Tapas
- Other IDs
- 2019-001022-95, 2019
- Acronym
- Tapas
- Status last verified
- Apr 2023
- First submitted
- 20 May 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans Abdominal Plane Block (TAP Block) in Surgery of Stoma Reversal and Its Effect on Post Operative Recovery: a Prospective, Randomized, Muticenter Study
- ClinicalTrials.gov ID
- NCT03971513
- Acronym / sponsor ID
- Tapas / RBHP 2019 VIGNAUD - Tapas
- Conditions
- Surgery, Stoma Ileostomy
- Keywords
- Prospective randomized pilot study, Trans abdominal plane block, Quo R 40 score, Post operative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 17 Apr 2023 (actual)
- First posted
- 3 Jun 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.
The primary purpose of TAPAS study is to demonstrate the superiority of analgesic effect of trans abdominal plane block (TAP block) performed at the beginning of stoma reversal, compared to standard of care.
The hypothesize is that a TAP block performed at the beginning of surgery of stoma reversal would improve patient's satisfaction (evaluated by Quo-r40 questionnaire), would reduce the incidence of post operative pain, time spent in recovery room, and reduce hospitalisation time
Detailed description
The patient will arrive in the department the day before the surgical intervention (D-1). During this preoperative visit (D-1), the investigator
- will preselect potentially eligible patients
- will offer to participate to this study
- will give the notice form to the patients
- will present the research: objectives, benefits and constraints for the patients
The intervention day (D0):
The investigator will collect the signed consent form after having ascertained the understanding of the notice form by the patient and checking the inclusion and non-inclusion criteria.
The randomization will be done via the eCRF module (allocation group and number) and the preoperative data registration in the eCRF.
Surgical Intervention (D1):
All patients will receive standard anaesthesia using sufentanyl, propopol, cisatracurium and sevoflurane. Prevention of nausea and vomiting is performing using Apfel score. Anti microbial prophylaxis is performed according recommendations.
All patients will receive post operative multimodal analgesia using, acetaminophene, ketaminophene (if no contra indication), nefopam, and morphine if NRS (numerating rating scale) > 3 At the end of the surgery, patients in the experimental group will receive a ultrasound guided trans abdominal plane block with 20 ml of 5 mg/mg of ropivacaine. Patients in the control group will not receive the block
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Model description: Randomization in 2 groups * Control group (usual practice): patients receiving a general anaesthesia with propofol, sufentanyl and cisatracurium for the induction, and sevoflurane, sufentanyl and cisatracurium for the maintenance. Patients receiving a multimodal intravenous analgesia, with acetaminophen, ketoprophen, nefopam and morphine if necessary Antimicrobial prophylaxis is performed according to recommendations. * Experimental group: patients receiving a general anaesthesia with propofol, sufentanyl and cisatracurium for the induction, and sevoflurane, sufentanyl and cisatracurium for the maintenance. Patients receiving a multimodal intravenous analgesia, with acetaminophen, ketoprophen, nefopan and morphine if necessary Antimicrobial prophylaxis is performed according to recommendations. In this group, a trans abdominal plane block, using 20 ml of ropivacaine 5 mg/ml is performed at the beginning of surgery, using ultrasound guidance.
| Arm | Type | Receives |
|---|---|---|
| usual practice | No intervention | –Control group (usual practice): patients receiving a general anaesthesia with propofol, sufentanyl and cisatracurium for the induction, and sevoflurane, sufentanyl and cisatracurium for the maintenance. Patients receiving a multimodal intravenous analgesia, with acetaminophen, ketoprophen, nefopam and morphine. if necessary. Antimicrobial prophylaxis is performed according to recommendations |
| TAP block | Experimental | Procedure: Trans abdominal planeIn addition of usual practice, patients receiving a TAP block at the beginning of the surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old
- Patients operated of a scheduled stoma reversal surgery
- Patients having given consent in the mannen described in Article L1122-1-1 of the Public Health Code
- Patients affiliated with asocial security regimen or beneficiary of such a regimen
Key exclusion criteria (9 listed)
- Renal insufficiency (ie glomerular filtration output < 35 ml/min)
- Patients with chronic inflammatory bowel disease
- Body mass index > 35 kg/m2
- Chronic pain with opiates
- Patients with cognitive troubles
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 |
|---|---|---|
| Trans abdominal planeTrans abdominal plane block is performed with ultra sound guidance. 1. - The high frequency probe is placed right to the umbilicus, and slips laterally to the side to block. It allows showing the three belts of larges muscles of abdomen (External Oblicum, internal oblicum, and transversal of the abdomen). 2. - When the needle is visualised in the plan separating the muscle internal oblicum and transversal of the abdomen, 20 ml of ropivacaïne 5mg/ml are injected after aspiration test. If in doubt, hydro localisation car be realised. | Procedure or surgery | TAP block |
Primary outcome
Quo 40 score
Time frame: Day 1 (
Once the patient is transferred in post operative surgical service, assessment of the primary outcome will be done by the physician in charge of the patient. Quo 40 score is a postoperative recovery score above 200 points validated by Myles et al in 2001.
5 secondary outcomes
NRS (Numeric rating scale)
Time frame: Day 1 : At the entrance of recovery room
NRS (Numeric rating scale)
Time frame: Day 1
NRS (Numeric rating scale)
Time frame: Day 2
Quo 40 score
Time frame: Day 15
Time spent in recovery room
Time frame: At the output of recovery room ie until 6 hours after intervention
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 18 Apr 2023.
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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.
Marie Vignaud principal investigator
CHU Clermont-Ferrand.fr
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans abdominal plane in people with Surgery and Stoma Ileostomy, run by University Hospital, Clermont-Ferrand at 2 sites 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 4 inclusion and 9 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Quo 40 score (time frame: Day 1 (). 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 18 Apr 2023.