None listed
Conditions
Brief summary
Robotic surgery represents an important innovations of the last decades with several benefits compared to conventional open and laparoscopic surgical approaches. One of the most common procedure performed using robotic systems is robot-assisted radical prostatectomy (RARP) with pain and bladder spasm representing the most important sources of discomfort for the patients. Pain relief is generally achieved through the administration of intravenous analgesic drugs and opioids play a primary role. The aim of this study is to compare subarachnoid analgesia to conventional intravenous opioid analgesia and erector spinae plane (ESP) block in reducing postoperative pain and bladder spasm in patients undergoing RARP. We hypothesizes that subarachnoid analgesia could ensure a better pain control thus allowing a faster mobilization with subsequent reduction of thromboembolism, infections, hospital stay, and costs.
Interventions
Group SUB: Subarachnoid analgesia (administered once only immediately before the general anesthesia) using 10.5 mg ropivacaine 0.75%, 30 mcg clonidine150 mcg/mL, 2 mcg/Kg morphine 100 mcg/mL and 0.03 mcg/Kg sufentanil 5 mcg/mL with a sterile 27 G needle at the L1-L2 or L2-L3 interspace. Thirty minutes before the end of the surgery, patients will be treated with a single intravenous bolus only of 1g of paracetmol and 30mg of ketorolac and a continuous intravenous infusion of 45 mg/day ketorolac a
Group SUB: Subarachnoid analgesia (administered once only immediately before the general anesthesia) using 10.5 mg ropivacaine 0.75%, 30 mcg clonidine150 mcg/mL, 2 mcg/Kg morphine 100 mcg/mL and 0.03 mcg/Kg sufentanil 5 mcg/mL with a sterile 27 G needle at the L1-L2 or L2-L3 interspace. Thirty minutes before the end of the surgery, patients will be treated with a single intravenous bolus only of 1g of paracetmol and 30mg of ketorolac and a continuous intravenous infusion of 45 mg/day ketorolac and 1 mcg/Kg/day clonidine started immediately after the bolus of paracetamol and ketorolac and administered over the 48 hour postoperative period. We will monitor the adherence to the intervention through audit of medication charts. Group ESP: before the general anesthesia, patients will undergo bilateral ultrasound-guided in-plane erector spinae plane (ESP) block performed once only per side, placing the needle between the erector spinae muscle and the transverse process of the T10 or T11 vertebra and injecting, for each side, 30 mcg clonidine, 4 mg dexamethasone, 100 mg ropivacaine (total volume 20 ml). In these patients a single intravenous bolus only of 1g of paracetamol and 30mg of ketorolac was given 30 minutes before the end of the surgery and a continuous intravenous infusion with 45 mg/day ketorolac and 1 mcg/Kg/day clonidine, starting immediately after the bolus of paracetamol and ketorolac, was administered over the 48 hour postoperative period. We will monitor the adherence to the intervention through audit of medication charts.
Sponsors
Pasquale Buonanno
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age greater than or equal to 18 years; American Society of Anesthesiologists (ASA) physical status I-III; Body Mass Index (BMI) < 35 kg/m2; diagnosis of prostate cancer.
Exclusion criteria
Severe respiratory and cardiovascular deficits; neuromuscular deficits (such as S. Guillain-Barrè, SLA, myasthenia gravis, muscular dystrophy); Renal Failure (Creatinine Clearance < 60 mL/min/1,73m2); Liver Failure (Child-Pugh Score B and C); allergy to study medication; contra-indications to spinal anesthesia (such as severe valvular hearth disease, increased intracranial pressure, coagulation disorders, sepsis, patient refusal)
Outcome results
None listed