Evaluation of Post-operative Biochemical Recurrence in Patients Submitted to Radical Prostatectomy Under General Opioid-free Anesthesia Compared to Conventional General Anesthesia

Not Applicable

• Conditions: Prostate Cancer
• Interventions: Drug: opioid-free group; Drug: Opioid Group; Procedure: transversus abdominal plane block with placebo; Procedure: transversus abdominal plane block with ropivacaine

• Registration Number: NCT03212456
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

Brief Summary

The use of opioids facilitates angiogenesis and has a proven action in the immune system, mainly in the reduction of natural killer cell activity, favoring the migration of neoplastic cells and inhibiting humoral and cellular immunity. These factors may contribute to recurrence and tumor metastasis.

Therefore, could opioid-free anesthesia help reduce tumor recurrence? This is a prospective randomized controlled clinical trial in which patients undergoing radical prostatectomy will be evaluated by conventional means, which have moderate and high D'Amico criteria for tumor recurrence.

In the operating room, patients will be monitored, receive peripheral venoclysis and then randomized into two groups: in group I, the anesthetic induction will be done with pre oxygenation with 100% O2, propofol, cisatracurium, lidocaine and fentanyl; In group II the induction will be done with the same doses of propofol, cisatracurium, lidocaine and placebo.

In both groups maintenance of general anesthesia will be with propofol 1% target infusion controlled with model of Marsh target-controlled infusion plasma between 2.0 and 3.0 mcg / ml, ketamine, lidocaine and dexmedetomidine.

Both groups will receive blockade of the transverse plane of the ultrasound guided ultrasound, group I with placebo (saline 0.9% 20 ml on each side) and group II with ropivacaine 0.375% 20 ml on each side. And the postoperative analgesia will be based on anti-inflammatory and opioid analgesics (pca of morphine) according to the analgesic pain scale of the patients.

In the postoperative period, patients will be followed up for 2 years with serial doses of prostate specific antigen (PSA) to diagnose tumor recurrence (2 PSA measures\> 0.2 ng / ml) and will be evaluated in relation to analgesia, need for analgesia of Rescue with morphine, satisfaction with the anesthetic technique, adverse effects (nausea and vomiting).

The primary objective is to evaluate tumor biochemical recurrence after radical prostatectomy in patients undergoing opioid anesthesia compared to patients anesthetized without opioids. The secondary objectives are to evaluate the quality of analgesia with the two techniques, patient satisfaction with perioperative period, quality of anesthetic recovery and adverse effects (nausea and vomiting, pruritus and drowsiness).

Thus, to answer the hypothesis raised, 146 patients will be needed (73 in each group).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-12
• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-07-06
• Study First Posted: 2017-07-11
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29
• Primary Completion: 2020-09-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 146

Inclusion Criteria

• Prostate Cancer;
• Intermediate to high risk of recurrence by D'Amico criteria (Gleason scale > or = 7; PSA > or = 10)

Exclusion Criteria

• Patient refuse;
• atrioventricular blockade;
• Coagulopathy;
• Other procedure at same time.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid-free	opioid-free group	The patients of this group will receive opioid-free anesthesia
Non opioid-free	transversus abdominal plane block with placebo	The patients in this group will receive the same induction and maintenance drugs of the experimental group but with fentanyl 3 - 5 mcg/kg on induction and during the procedure as needed.
Opioid-free	transversus abdominal plane block with ropivacaine	The patients of this group will receive opioid-free anesthesia
Non opioid-free	Opioid Group	The patients in this group will receive the same induction and maintenance drugs of the experimental group but with fentanyl 3 - 5 mcg/kg on induction and during the procedure as needed.

Primary Outcome Measures

Name	Time	Method
Biochemical recurrence of prostate cancer	Up to 2 years after the date of the surgery	It's going to be measured the prostate specific antigen in 4 times after the date of the surgery( 6 months, 1 year, 1 and a half year and 2 years after the surgery) to compare elevations between the two groups.

Secondary Outcome Measures

Name	Time	Method
Satisfaction with anesthesia technique	Up to 2 hours postoperatively	compare the satisfaction (a scale from 01 to 10) with anesthesia technique between the two groups at delivery of post-anaesthesia care unit
Neutrophil-to-lymphocyte ratio	24 hour postoperatively	Compare the peutrophil-to-lymphocyte ratio preoperatively and with 24 hour postoperatively between the two groups to study about inflammation.
adverse outcomes	Up to 2 hours postoperatively	compare the postoperative adverse outcomes (such as nausea, pruritus, somnolence) between the two groups at delivery of post-anaesthesia care unit
visual analogue pain score in the post-anaesthesia care unit	Up to 2 hours postoperatively	Compare the pain scale between the two groups in the delivery of post-anaesthesia care unit
Rescue Morphine	Up to 2 hours postoperatively	compare the total dosis needed for pain at delivery post-anaesthesia care unit

Trial Locations

Locations (1)

Instituto do Cancer do Estado de Sao Paulo - Icesp; 🇧🇷 Sao Paulo, SP, Brazil