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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03212456
• Other study ID #: NP 834/15
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 12, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2020
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 146
• Est. completion date: December 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Recurrence

Intervention

Drug:
• opioid-free group
We'll study if the opioid-free anesthesia can reduce the biochemical recurrence of prostate cancer.
• Opioid Group
This group will receive fentanyl in the induction of anesthesia.

Procedure:
• transversus abdominal plane block with ropivacaine
The opioid-free group will receive transversus abdominal plane block with ropivacaine 0,375% 20 ml each side
• transversus abdominal plane block with placebo
the non-opioid free group will receive transversus abdominal plane block with physiological solution 0,9% 20 ml each side

Locations

Country	Name	City	State
Brazil	Instituto do Cancer do Estado de Sao Paulo - Icesp	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

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