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

NCT03212456 | Unknown DMC

• 1 other identifier: NP 834/15
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer

Keywords

general anesthesia; cancer recurrence; opioids analgesics; neoplasm

Outcome Measures

Primary Outcomes (1)

• Biochemical recurrence of prostate cancer

  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.

  Up to 2 years after the date of the surgery

Secondary Outcomes (5)

• 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

Study Arms (2)

Opioid-free

EXPERIMENTAL

The patients of this group will receive opioid-free anesthesia

Drug: opioid-free group; Procedure: transversus abdominal plane block with ropivacaine

Non opioid-free

ACTIVE COMPARATOR

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.

Drug: Opioid Group; Procedure: transversus abdominal plane block with placebo

Interventions

opioid-free group DRUG

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

Opioid-free

Opioid Group DRUG

This group will receive fentanyl in the induction of anesthesia.

Non opioid-free

transversus abdominal plane block with ropivacaine PROCEDURE

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

Opioid-free

transversus abdominal plane block with placebo PROCEDURE

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

Non opioid-free

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Instituto do Cancer do Estado de Sao Paulo - Icesp

São Paulo, São Paulo, 01246-903, Brazil

Location

Related Publications (1)

• Rangel FP, Auler JOC Jr, Carmona MJC, Cordeiro MD, Nahas WC, Coelho RF, Simoes CM. Opioids and premature biochemical recurrence of prostate cancer: a randomised prospective clinical trial. Br J Anaesth. 2021 May;126(5):931-939. doi: 10.1016/j.bja.2021.01.031. Epub 2021 Mar 10.

  PMID: 33712224 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesiologist, principal investigator

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: July 11, 2017
• Study Start: January 12, 2017
• Primary Completion: September 30, 2020
• Study Completion: December 30, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)