Quadratus lumborum 3 block (QLB3) for laparoscopic colorectal surgery: A double blind, prospective randomized placebo-controlled trial.
Phase 1
- Conditions
- postoperative painTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2019-002304-40-BE
- Lead Sponsor
- niversity Hospitals Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
-18-75 years of age
-BMI = 35
-Patient is able to give informed consent
-Patient understands the use of morphine PCIA
-Patient is scheduled for elective laparoscopic colorectal surgery
-ASA I-III
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85
Exclusion Criteria
-Refusal to participate in the trial
-Inability to operate a PCIA system
-Chronic opioid use
-Patient has moderate to severe kidney failure (GFR < 44 mL/min)
-Patient has acute or chronic liver insufficiency as defined by:
?Bilirubine (µmol/l) = 34
?Albumine (g/l) = 35
INR<=1.7
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: not applecable;Main Objective: The goal of this study is to improve pain management, minimize the need for postoperative opioids and to facilitate postoperative recovery after laparoscopic colorectal surgery. Our hypothesis is that a bilateral single shot QLB 3 block with 30mL ropivacaine 0,375% on each side is associated with a reduction in postoperative morphine consumption as compared to normal saline 0,9%. Superiority of the QLB 3 block will be defined as a 30% reduction in the cumulative 24-hour morphine consumption post-surgery.;Primary end point(s): cumulative 24-hour morphine consumption;Timepoint(s) of evaluation of this end point: 24 hours after start PCIA pump
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Pain intensity as assessed with the numerical rating score for pain<br> Extent of motor block<br> extent of sensory block<br> incidence of adverse events during treatment<br> ;<br> Timepoint(s) of evaluation of this end point: NRS Pain: every 15 min after arrival in the PACU until +120 min, 2h, 3h, 4h and 24h postoperative<br> Extent of motor and sensory block 1h, 2h, 3h and 4h after arrival in the PACU<br> Patient satisfaction score 24h post surgery.<br> Incidence of adverse events: continuously until 24h post operative<br>