Bilateral Dual Transversus Abdominis Plane Block for Robotic Assisted Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of bilateral dual transversus abdominis plane block on postoperative pain after robotic assited laparoskopic surgery and measure the plasma-level of ropivacain after the bilateral dual transversus abdominis plane block.

Detailed Description
-----------------
After randomisation patients for robotic assisted laparoscopic surgery will receive bilateral dual transversus abdominis plane block containing either ropivacain or isotonic potassium chloride. The investigators will record pain-score, opioid-consumption and sensibility on the abdominal wall in the postoperative periode. Also a blood sample will be taken at 15, 30, 60, 120 and 240 minutes after the block in order to measure the plasma-level of ropivacain after bilateral dual transversus abdominis plane block. The investigators assume that there will be significant effect on postoperative pain and that the level of plasma-ropivacain will be acceptable.

Official Title
-----------------
A Randomised, Double-blind Study to Evaluate the Effect of Bilateral Dual Transversus Abdominis Plane Block on Postoperative Pain and Plasma Concentration of Ropivacaine After Robotic Assisted Laparoscopic Surgery

Conditions
-----------------
Pain Treatment, Robotic Assisted Laparoscopic Surgery, Bilateral Dual Transversus Abdominis Plane Block

Intervention / Treatment
-----------------
* Drug: Ropivacaine
* Drug: Isotonic potassium chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for robotic assisted laparoscopis surgery acceptance to participate Exclusion Criteria: allergies to local analgetics daily use of strong opioids

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ropivacain<br>Ropicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block | Drug: Ropivacaine<br>* Ropicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block<br>|
| Placebo Comparator: Isotonic potassium chloride<br>Isotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block. | Drug: Isotonic potassium chloride<br>* Isotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-score on numerical rating scale |  | 4 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Administration of opioids |  | The first 24 hours after surgery. | 
| Pain-score on numerical rating scale |  | 8 hours after surgery | 
| Pain-score on numerical rating scale |  | 24 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative pain, opioid consumption, termanalgesia, plasmaropivacain level