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 / Analgesic Effect of Bilateral Quadratus Lumborum Block in the End of Colorectal Laparosopic Surgery. (Coloqual)

Analgesic Effect of Bilateral Quadratus Lumborum Block in the End of Colorectal Laparosopic Surgery. (Coloqual)

Study Description
Brief Summary:

The primary purpose of COLOQUAL study is to demonstrate the superiority of analgesic effect of a bilateral quadratus lumborum block (QLB), performed at the end of laparoscopic colorectal surgery, compared to standard of care.

The investigators hypothesized that a bilateral quadratus lumborum block performed at the end of laparoscopic colorectal surgery would reduce the incidence of post operative pain, time spent in recovery room, improve patient's satisfaction, and reduce hospitalisation time


Condition or disease Intervention/treatment Phase
Post Operative Pain Laparoscopic Colorectal Surgery Procedure: Quadratus lumborum block Not Applicable

Detailed Description:

Visits:

  • The patient will arrive in the department the day before the surgical intervention (Day-1). During this preoperative visit (Day-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 (Day 0):

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 (Day 1):

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 intravenous lidocaine, acetaminophene, ketaminophene, and morphine if NRS (numerating rating scale) > 3 At the end of the surgery, patients in the experimental group will receive a bilateral ultrasound guided quadratus lumborum block with 15 ml of 3,75 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 : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 and morphine. 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 and morphine. Antimicrobial prophylaxis is performed according to recommendations. In this group, a bilateral quadratus lumborum block, using 20 ml of ropivacaine 3, 75 mg/ml is performed at the end of surgery, using ultrasound guidance.
Masking: Single (Participant)
Masking Description: During the assess period, the participant and the research staff involved in the data collection will be blinded to the randomization group
Primary Purpose: Prevention
Official Title: Analgesic Effect of Bilateral Quadratus Lumborum Block in the End of Colorectal Laparosopic Surgery: a Prospective Randomized Pilot Study
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : April 9, 2021
Estimated Study Completion Date : June 30, 2021
Arms and Interventions
Arm Intervention/treatment
No Intervention: 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 and morphine. Antimicrobial prophylaxis is performed according to recommendations
Experimental: QLB block

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 and morphine. Antimicrobial prophylaxis is performed according to recommendations.

In addition, patients receiving a bilateral QLB at the end of the surgery

Procedure: Quadratus lumborum block
  • Bilateral Quatratus lumborum 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). Laterally, these three are merging to from fascia transversalis. Under fascia transversalis, we can see quadratus lumborum muscle. Punction point in lateral, 1cm in the plan separating quadratus lumborum block and fascia transversalis
  • 20 ml of ropivacaïne 3.75mg/ml are injected after aspiration test. If in doubt, hydro localisation car be realised.

Outcome Measures
Primary Outcome Measures :
  1. Morphine Consumption in milligramme [ Time Frame: 8 AM (ante meridiem) the day after surgery ]
    Once the patient is transferred in post operative surgical service, assessment of the primary outcome will be done by the nurse in charge of the patient


Secondary Outcome Measures :
  1. NRS (Numeric rating scale) [ Time Frame: At the entrance of recovery room, at day 1 and Day 2 after surgery ]
    Numerating rating score evaluating pain and variating from 0 (No pain) to 10 (Maximum Pain), done by nurses in operating room and in post operative surgical service

  2. Post Operative recovery: QUO-R4O questionnaire [ Time Frame: At Day 1 and day 15 after surgery ]
    Quo 40 score is a postoperative recovery score above 200 points (40 is worst score and 200 the best score) validated by Myles et al in 2001.

  3. Time spent in recovery room (in minutes) [ 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


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 laparoscopic colorectal 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
  • Laparotomy conversion
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Lise Laclautre +33 4754 963 promo_interne_drci@chu-clermontferrand.fr

Locations
Layout table for location information
France
CHU Recruiting
Clermont-Ferrand, France, 63000
Contact: Marie Vignaud       mvignaud@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Layout table for investigator information
Principal Investigator: Marie Vignaud University Hospital, Clermont-Ferrand
Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE June 24, 2019
Estimated Primary Completion Date April 9, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2019)
Morphine Consumption in milligramme [ Time Frame: 8 AM (ante meridiem) the day after surgery ]
Once the patient is transferred in post operative surgical service, assessment of the primary outcome will be done by the nurse in charge of the patient
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2019)
  • NRS (Numeric rating scale) [ Time Frame: At the entrance of recovery room, at day 1 and Day 2 after surgery ]
    Numerating rating score evaluating pain and variating from 0 (No pain) to 10 (Maximum Pain), done by nurses in operating room and in post operative surgical service
  • Post Operative recovery: QUO-R4O questionnaire [ Time Frame: At Day 1 and day 15 after surgery ]
    Quo 40 score is a postoperative recovery score above 200 points (40 is worst score and 200 the best score) validated by Myles et al in 2001.
  • Time spent in recovery room (in minutes) [ 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
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 Analgesic Effect of Bilateral Quadratus Lumborum Block in the End of Colorectal Laparosopic Surgery.
Official Title  ICMJE Analgesic Effect of Bilateral Quadratus Lumborum Block in the End of Colorectal Laparosopic Surgery: a Prospective Randomized Pilot Study
Brief Summary

The primary purpose of COLOQUAL study is to demonstrate the superiority of analgesic effect of a bilateral quadratus lumborum block (QLB), performed at the end of laparoscopic colorectal surgery, compared to standard of care.

The investigators hypothesized that a bilateral quadratus lumborum block performed at the end of laparoscopic colorectal surgery would reduce the incidence of post operative pain, time spent in recovery room, improve patient's satisfaction, and reduce hospitalisation time

Detailed Description

Visits:

  • The patient will arrive in the department the day before the surgical intervention (Day-1). During this preoperative visit (Day-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 (Day 0):

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 (Day 1):

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 intravenous lidocaine, acetaminophene, ketaminophene, and morphine if NRS (numerating rating scale) > 3 At the end of the surgery, patients in the experimental group will receive a bilateral ultrasound guided quadratus lumborum block with 15 ml of 3,75 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:

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 and morphine. 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 and morphine. Antimicrobial prophylaxis is performed according to recommendations. In this group, a bilateral quadratus lumborum block, using 20 ml of ropivacaine 3, 75 mg/ml is performed at the end of surgery, using ultrasound guidance.
Masking: Single (Participant)
Masking Description:
During the assess period, the participant and the research staff involved in the data collection will be blinded to the randomization group
Primary Purpose: Prevention
Condition  ICMJE
  • Post Operative Pain
  • Laparoscopic Colorectal Surgery
Intervention  ICMJE Procedure: Quadratus lumborum block
  • Bilateral Quatratus lumborum 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). Laterally, these three are merging to from fascia transversalis. Under fascia transversalis, we can see quadratus lumborum muscle. Punction point in lateral, 1cm in the plan separating quadratus lumborum block and fascia transversalis
  • 20 ml of ropivacaïne 3.75mg/ml are injected after aspiration test. If in doubt, hydro localisation car be realised.
Study Arms  ICMJE
  • No Intervention: 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 and morphine. Antimicrobial prophylaxis is performed according to recommendations
  • Experimental: QLB block

    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 and morphine. Antimicrobial prophylaxis is performed according to recommendations.

    In addition, patients receiving a bilateral QLB at the end of the surgery

    Intervention: Procedure: Quadratus lumborum block
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 27, 2019)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date April 9, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age > 18 years old
  • Patients operated of a scheduled laparoscopic colorectal 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
  • Laparotomy conversion
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 4754 963 promo_interne_drci@chu-clermontferrand.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03966092
Other Study ID Numbers  ICMJE RBHP 2018 VIGNAUD_Coloqual
2019-000277-23 ( 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 University Hospital, Clermont-Ferrand
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