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

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

Sponsors

Lead Sponsor: Instituto do Cancer do Estado de São Paulo

Source 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).

Overall Status Active, not recruiting
Start Date January 12, 2017
Completion Date December 30, 2020
Primary Completion Date September 30, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Biochemical recurrence of prostate cancer Up to 2 years after the date of the surgery
Secondary Outcome
Measure Time Frame
Neutrophil-to-lymphocyte ratio 24 hour postoperatively
visual analogue pain score in the post-anaesthesia care unit Up to 2 hours postoperatively
Rescue Morphine Up to 2 hours postoperatively
Satisfaction with anesthesia technique Up to 2 hours postoperatively
adverse outcomes Up to 2 hours postoperatively
Enrollment 146
Condition
Intervention

Intervention Type: Drug

Intervention Name: opioid-free group

Description: We'll study if the opioid-free anesthesia can reduce the biochemical recurrence of prostate cancer.

Arm Group Label: Opioid-free

Intervention Type: Drug

Intervention Name: Opioid Group

Description: This group will receive fentanyl in the induction of anesthesia.

Arm Group Label: Non opioid-free

Intervention Type: Procedure

Intervention Name: transversus abdominal plane block with ropivacaine

Description: The opioid-free group will receive transversus abdominal plane block with ropivacaine 0,375% 20 ml each side

Arm Group Label: Opioid-free

Intervention Type: Procedure

Intervention Name: transversus abdominal plane block with placebo

Description: the non-opioid free group will receive transversus abdominal plane block with physiological solution 0,9% 20 ml each side

Arm Group Label: Non opioid-free

Eligibility

Criteria:

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.

Gender: Male

Minimum Age: 40 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Location
Facility: Instituto do Cancer do Estado de Sao Paulo - Icesp
Location Countries

Brazil

Verification Date

July 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Instituto do Cancer do Estado de São Paulo

Investigator Full Name: Felipe Rangel

Investigator Title: MD, Anesthesiologist, principal investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Opioid-free

Type: Experimental

Description: The patients of this group will receive opioid-free anesthesia

Label: Non opioid-free

Type: Active Comparator

Description: 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.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov