4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Trans Abdominal Plane Block (TAP Block) in Surgery of Stoma Reversal and Its Effect on Post Operative Recovery: a Prospective, Randomized, Muticenter Study (Tapas)

Trans Abdominal Plane Block (TAP Block) in Surgery of Stoma Reversal and Its Effect on Post Operative Recovery: a Prospective, Randomized, Muticenter Study (Tapas)

Study Description
Brief 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.

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


Condition or disease Intervention/treatment Phase
Surgery Stoma Ileostomy Procedure: Trans abdominal plane Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : April 1, 2021
Arms and Interventions
Arm Intervention/treatment
No Intervention: usual practice
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: TAP block
In addition of usual practice, patients receiving a TAP block at the beginning of the surgery
Procedure: Trans abdominal plane

Trans 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.

Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. NRS (Numeric rating scale) [ Time Frame: Day 1 : At the entrance of recovery room ]
    Numerating rating score variating from 0 to 10, done by nurses in operating room and in post operative surgical service

  2. NRS (Numeric rating scale) [ Time Frame: Day 1 ]
    Numerating rating score variating from 0 to 10, done by nurses in operating room and in post operative surgical service

  3. NRS (Numeric rating scale) [ Time Frame: Day 2 ]
    Numerating rating score variating from 0 to 10, done by nurses in operating room and in post operative surgical service

  4. Quo 40 score [ Time Frame: Day 15 ]
    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. Time spent in recovery room [ Time Frame: At the output of recovery room ie until 6 hours after intervention ]
    Assessment of time spent in recovery room (ie: entrance in recovery room until Aldrede score is >9) performed by nurses (Until 6 hours).


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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%)
  • Pregnancy
  • Breastfeeding
  • Local anesthesics (amide class) allergy
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Lise Laclautre 33 4 73 754 963 promo_interne_drci@chu-clermontferrand.fr

Locations
Layout table for location information
France
CHU Recruiting
Clermont-Ferrand, France
Contact: Marie Vignaud         
CHU Rennes Recruiting
Rennes, France, 35033
Contact: Hélène Beloeil       Helene.BELOEIL@chu-rennes.fr   
Principal Investigator: Hélène Beloeil         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Layout table for investigator information
Principal Investigator: Marie Vignaud CHU Clermont-Ferrand.fr
Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE June 17, 2019
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • NRS (Numeric rating scale) [ Time Frame: Day 1 : At the entrance of recovery room ]
    Numerating rating score variating from 0 to 10, done by nurses in operating room and in post operative surgical service
  • NRS (Numeric rating scale) [ Time Frame: Day 1 ]
    Numerating rating score variating from 0 to 10, done by nurses in operating room and in post operative surgical service
  • NRS (Numeric rating scale) [ Time Frame: Day 2 ]
    Numerating rating score variating from 0 to 10, done by nurses in operating room and in post operative surgical service
  • Quo 40 score [ Time Frame: Day 15 ]
    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.
  • Time spent in recovery room [ Time Frame: At the output of recovery room ie until 6 hours after intervention ]
    Assessment of time spent in recovery room (ie: entrance in recovery room until Aldrede score is >9) performed by nurses (Until 6 hours).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trans Abdominal Plane Block (TAP Block) in Surgery of Stoma Reversal and Its Effect on Post Operative Recovery: a Prospective, Randomized, Muticenter Study
Official Title  ICMJE Trans Abdominal Plane Block (TAP Block) in Surgery of Stoma Reversal and Its Effect on Post Operative Recovery: a Prospective, Randomized, Muticenter Study
Brief 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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Surgery
  • Stoma Ileostomy
Intervention  ICMJE Procedure: Trans abdominal plane

Trans 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.
Study Arms  ICMJE
  • No Intervention: usual practice
    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: TAP block
    In addition of usual practice, patients receiving a TAP block at the beginning of the surgery
    Intervention: Procedure: Trans abdominal plane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2021
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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%)
  • Pregnancy
  • Breastfeeding
  • Local anesthesics (amide class) allergy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lise Laclautre 33 4 73 754 963 promo_interne_drci@chu-clermontferrand.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03971513
Other Study ID Numbers  ICMJE RBHP 2019 VIGNAUD - Tapas
2019-001022-95 ( Other Identifier: ANSM )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor  ICMJE University Hospital, Clermont-Ferrand
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marie Vignaud CHU Clermont-Ferrand.fr
PRS Account University Hospital, Clermont-Ferrand
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院