Evaluation of Post-operative Biochemical Recurrence in Patients Submitted to Radical Prostatectomy Under General Opioid-free Anesthesia Compared to Conventional General Anesthesia
NCT ID: NCT03212456
Last Updated: 2020-07-29
Study Results
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Basic Information
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UNKNOWN
NA
146 participants
INTERVENTIONAL
2017-01-12
2020-12-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Opioid-free
The patients of this group will receive opioid-free anesthesia
opioid-free group
We'll study if the opioid-free anesthesia can reduce the biochemical recurrence of prostate cancer.
transversus abdominal plane block with ropivacaine
The opioid-free group will receive transversus abdominal plane block with ropivacaine 0,375% 20 ml each side
Non opioid-free
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 Group
This group will receive fentanyl in the induction of anesthesia.
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* Intermediate to high risk of recurrence by D'Amico criteria (Gleason scale \> or = 7; PSA \> or = 10)
Exclusion Criteria
* atrioventricular blockade;
* Coagulopathy;
* Other procedure at same time.
40 Years
80 Years
MALE
No
Sponsors
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Instituto do Cancer do Estado de São Paulo
OTHER
Responsible Party
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Felipe Rangel
MD, Anesthesiologist, principal investigator
Locations
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Instituto do Cancer do Estado de Sao Paulo - Icesp
São Paulo, São Paulo, Brazil
Countries
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References
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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.
Other Identifiers
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NP 834/15
Identifier Type: -
Identifier Source: org_study_id
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