Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Laparoscopic Hand-assisted Nephrectomy and Robot Assisted Partiel Nephrectomy

Study Overview
=================
Brief Summary
-----------------
Patients with kidney cancer often undergo hand-assisted laparoscopic nephrectomy or Robot assisted partiel nephrectomy. The investigators performed a one-year retrospective study. the sudy revealed that 67% of the patients needed substantial amounts of opioids for postoperative pain management (PPM) in recovery despite a multimodal analgesic regime. In a prospective pilot study including ten laparoscopic hand-assisted nephrectomy, with severe postoperative pain the investigators found that bilateral Ultrasound-guided (USG) transmuscular quadratus lumborum (TQL) block substantially reduced pain and opioid consumption. This study aims to evaluate the effect on PPM of a bilateral USG TQL block compared to placebo.

Official Title
-----------------
Improving Postoperative Pain Management With the Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Laparoscopic Hand-assisted Nephrectomy and Robot-assisted Partiel Nephrectomy: A Double Blind, Randomized, Placebo Controlled Trial

Conditions
-----------------
Postoperative Pain, Ultrasound Guided Transmuscular Quadratus Lumborum Block

Intervention / Treatment
-----------------
* Drug: Ropivacaine
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years Kidney cancer Have received thorough information, orally and in written Signed the Informed Consent form on participation in the trial Exclusion Criteria: Inability to cooperate Inability to speak and understand Danish both orally and written Allergy to local anaesthetics or opioids Daily intake of opioids Local infection at the site of injection or systemic infection Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration Known abuse of alcohol or medicine Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Double blind placebo Controlled Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TQL Ropivacaine(active)<br>Bilateral Single shot of ropivacaine 0.325% 30 mL. In total 60 mL of 0.325% ropivacaine | Drug: Ropivacaine<br>* Single shot of ropivacaine 0.325%<br>|
| Placebo Comparator: TQL saline (placebo)<br>Bilateral single shot of saline 0.9% 30 mL. in Total 60 mL of saline 0.9% | Drug: Saline<br>* Single shot of saline 0.9%<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid consumption | Opioid consumption postoperatively: data from Patient Controlled Analgesia(PCA) pump and patient medical record). | 12 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid consumption | Opioid consumption postoperatively (data from PCA pump and patient medical record). | 6 hours postoperatively | 
| opioid consumption | Opioid consumption postoperatively (data from PCA pump and patient medical record). | 18 hours postoperatively | 
| opioid consumption | Opioid consumption postoperatively (data from PCA pump and patient medical record). | 24 hours postoperatively | 
| NRS score | Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain postoperatively at rest and activity | 12 hours postoperatively | 
| NRS score at rest and activity | Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain | 6 hours postoperatively | 
| NRS score at rest and activity | Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain | 18 hours postoperatively | 
| NRS score at rest and activity | Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain | 24 hours postoperatively | 
| Opioid-related side effects | The degree of morphine-related side effects (PONV, itching, fatigue, etc.) | 6 hours postoperatively | 
| Opioid-related side effects | The degree of morphine-related side effects (PONV, itching, fatigue, etc.) | 12 hours postoperatively | 
| Opioid-related side effects | The degree of morphine-related side effects (PONV, itching, fatigue, etc.) | 18 hours postoperatively | 
| Opioid-related side effects | The degree of morphine-related side effects (PONV, itching, fatigue, etc.) | 24 hours postoperatively | 
| Patient satisfaction with application of the block. NRS | Numeric Rating Scale(NRS). Scores range from 0-10, 0=no pain-10=worst pain | Immediately after application of the block | 
| Ambulation | Time from operation to ambulation | within 24 hours postoperatively |