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Trial record 71 of 150 for:    Recruiting, Not yet recruiting, Available Studies | Prostatectomy

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

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ClinicalTrials.gov Identifier: NCT03212456
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Felipe Rangel, 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).


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: opioid-free group Drug: Opioid Group Procedure: transversus abdominal plane block with ropivacaine Procedure: transversus abdominal plane block with placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Post-operative Biochemical Recurrence in Patients Submitted to Radical Prostatectomy Under General Opioid-free Anesthesia Compared to Conventional General Anesthesia
Actual Study Start Date : January 12, 2017
Estimated Primary Completion Date : December 28, 2017
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Opioid-free
The patients of this group will receive opioid-free anesthesia
Drug: opioid-free group
We'll study if the opioid-free anesthesia can reduce the biochemical recurrence of prostate cancer.

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

Active Comparator: 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.
Drug: Opioid Group
This group will receive fentanyl in the induction of anesthesia.

Procedure: 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




Primary Outcome Measures :
  1. Biochemical recurrence of prostate cancer [ Time Frame: 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 :
  1. Neutrophil-to-lymphocyte ratio [ Time Frame: 24 hour postoperatively ]
    Compare the peutrophil-to-lymphocyte ratio preoperatively and with 24 hour postoperatively between the two groups to study about inflammation.

  2. visual analogue pain score in the post-anaesthesia care unit [ Time Frame: Up to 2 hours postoperatively ]
    Compare the pain scale between the two groups in the delivery of post-anaesthesia care unit

  3. Rescue Morphine [ Time Frame: Up to 2 hours postoperatively ]
    compare the total dosis needed for pain at delivery post-anaesthesia care unit

  4. Satisfaction with anesthesia technique [ Time Frame: 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

  5. adverse outcomes [ Time Frame: 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



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212456


Contacts
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Contact: Felipe P Rangel, MD +5521983011516 felipe_prangel@yahoo.com.br

Locations
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Brazil
Instituto do Cancer do Estado de Sao Paulo - Icesp Recruiting
Sao Paulo, SP, Brazil, 01246-903
Contact: Felipe P Rangel, MD    +5521983011516    felipe_prangel@yahoo.com.br   
Principal Investigator: Felipe P Rangel, MD         
Sub-Investigator: Claudia M Simoes, PhD         
Sub-Investigator: Maria Jose C Carmona, PhD         
Sub-Investigator: Jose Otavio C Auler Jr, PhD         
Sub-Investigator: Mauricio D Cordeiro, MD         
Sub-Investigator: William C Nahas, PhD         
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo

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Responsible Party: Felipe Rangel, MD, Anesthesiologist, principal investigator, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT03212456     History of Changes
Other Study ID Numbers: NP 834/15
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The following data will be available: which group the patient were randomized; BMI; PSA preoperatively, 6 months, 1 year, 1,5 year and 2 years; prostate volume; gleason scale; neutrophil-to-lymphocyte ratio preoperatively and postoperatively; bleeding; intraoperative hydration; amount of opioids in the intraoperative period; VAS pain scale in the PACU and morphine dosis in the PACU

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Felipe Rangel, Instituto do Cancer do Estado de São Paulo:
general anesthesia
cancer recurrence
opioids analgesics
neoplasm

Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes
Anesthetics
Ropivacaine
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local