None listed
Conditions
Brief summary
The postoperative pain treatment in robot assisted nephrectomy is generally based on the use of systemic analgesic drugs and opioids play a fundamental role. These drugs are characterized by various side effects. In order to optimize pain control, it is possible to combine general anesthesia with subarachnoid analgesia, a technique which allows a dramatic reduction of drug dose and consequently a reduction of side effects by the direct administration of the opioid in the central nervous system. Subarachnoid analgesia (SAA) has proved to be a safe technique, especially when performed at the lumbar level, and it is associated with serious complications only in rare cases. Another technique that effectively reduces intra and postoperative pain in total nephrectomy is represented by the combination of the Transversus Abdominis Plain Block (TAPB) and the Quadratus Lumborum Block (QLB); these approaches showed to be reliable as the ultrasound-guide allows to visualize all the structures involved in the procedure. Our aim is to compare the efficacy of SAA, TAPB associated to QLB, and intravenous analgesia in postoperative pain control in robot assisted total nephrectomy.
Interventions
Group TQ: After the tracheal intubation transversus abdominis plane block (TAP block) and Quadratus Lumborum Blocks type 1 and 2 will be performed by an anaesthesist of the study team with ultrasound guidance using an in-plane technique. In the subcostal and posterior TAP-Block + Quadratus Lumborum Block type 1 the posterior abdominal wall will be infiltrated once only with an anesthetic mixture of ropivacaine 75 mg, clonidine 30 mcg, dexamethasone 2 mg, in a total volume of 20 ml. In the Quadr
Group TQ: After the tracheal intubation transversus abdominis plane block (TAP block) and Quadratus Lumborum Blocks type 1 and 2 will be performed by an anaesthesist of the study team with ultrasound guidance using an in-plane technique. In the subcostal and posterior TAP-Block + Quadratus Lumborum Block type 1 the posterior abdominal wall will be infiltrated once only with an anesthetic mixture of ropivacaine 75 mg, clonidine 30 mcg, dexamethasone 2 mg, in a total volume of 20 ml. In the Quadratus Lumborum Block type 2, the anesthetic mixture is injected into the posterior segment of the Quadratus Lumborum muscle under ultrasound guidance. In the type 3 block, on the other hand, the needle is positioned between the Quadratus Lumborum muscle and the psoas muscle fascia at the level of L4 transverse process. For each block (performed at the side of intervention) an anesthetic mixture of ropivacaine 50 mg clonidine 15 mcg, dexamethasone 2 mg, in a total volume of 15 ml per block will be injected. GROUP S: Before general anesthesia, a subarachnoid analgesia will be performed by an anaesthesist of the study team using a 27 G Whitacre needle, in L1-L2 or L2-L3 intervertebral spaces, using:10 mg of ropivacaine, 0,4 µg/kg (ideal weight) of Clonidine 150µg/ml, 2 µg/kg (ideal weight) of morphine 100µg/ml, 0,02 µg/kg (ideal weight) of sufentanil 5 µg/ml in a total volume of 5 ml of saline. The following parameters will be evaluated right after the recovery from general anesthesia (T0) and at 3, 6, 12, 24,and 48 hours (T3, T6, T12, T24, T48, respectively) from the end of the intervention: static and dynamic NRS, bladder spasms evaluated with a 5 points Likert scale, opioids side effects (nausea, vomiting, dizziness, sedation, itching). We will also record the time between the end of the surgery and the request for the first analgesic additional dose, the number of additional analgesic doses in the first postoperative 48 hours, the possible occurrence of side effects related to the performed procedures, the time between the recovery of gut motility and patient's ability to autonomously walk; we will also evaluate the length of hospital stay and the degree of patient's satisfaction measured with a 5 point Likert scale. STUDY DURATION TIME: 6 months.
Sponsors
Pasquale Buonanno
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Age > 18 years ASA I-III Body Mass Index between 18.5 and 35 kg/m2
Exclusion criteria
Severe respiratory or cardiovascular deficits Neuromuscular Deficit (such as Muscular Dystrophies, Myasthenia Gravis, Guillain-Barrè Syndrome, Amyotrophic lateral sclerosis) Renal failure (creatinine clearance <30mL/min/1,73m2) Hepatic Failure (Child-Pugh score B and C) Psychiatric disorders Allergy or hypersensitivity to drugs used in our protocol Absolute contraindication to subarachnoid anesthesia (patient refuse, congenital or acquired coagulopathy, surgical site infection, clinically relevant valvular diseases, increased intracranial pressure, severe hypovolemia, sepsis). Psychotropic drugs ongoing therapy Chronic therapy with opioids Concomitant participation to other scientific studies Incapability to understand risks connected to the study or to provide informed consent
Outcome results
None listed