Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000277-23 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Visits:
The patient will arrive in the department the day before the surgical intervention (Day-1). During this preoperative visit (Day-1), the investigator
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual practice | No Intervention | 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 | |
| QLB block | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadratus lumborum block | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Consumption in milligramme | 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 | 8 AM (ante meridiem) the day after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| NRS (Numeric rating scale) | 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 | At the entrance of recovery room, at day 1 and Day 2 after surgery |
| Post Operative recovery: QUO-R4O questionnaire |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marie Vignaud | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU | Clermont-Ferrand | 63000 | France |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
Randomization in 2 groups
Not provided
Not provided
During the assess period, the participant and the research staff involved in the data collection will be blinded to the randomization group
|
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. |
| At Day 1 and day 15 after surgery |
| Time spent in recovery room (in minutes) | Assessment of time spent in recovery room (ie: entrance in recovery room until Aldrede score is >9) performed by nurses | At the output of recovery room ie until 6 hours after intervention |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |