Prostate CancerNCT03212456
Evaluation of Post-operative Biochemical Recurrence in Patients Submitted to Radical Prostatectomy Under General Opioid-free Anesthesia Compared to Conventional General Anesthesia
A study testing opioid-free group, Opioid Group and transversus abdominal plane block with ropivacaine in people with Prostate Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- opioid-free group, Opioid Group and transversus abdominal plane block with ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Jan 2017to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostate Cancer;
- Intermediate to high risk of recurrence by D'Amico criteria (Gleason scale > or = 7; PSA > or = 10)
Who cannot join
- Patient refuse;
- atrioventricular blockade;
- Coagulopathy;
- Other procedure at same time.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Cancer do Estado de Sao Paulo - Icesp
São Paulo, São Paulo, 01246-903
About this study
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.
Read more
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
- Being tested
- opioid-free group, Opioid Group, transversus abdominal plane block with ropivacaine, transversus abdominal plane block with placebo
- Keywords
- general anesthesia, cancer recurrence, opioids analgesics, neoplasm
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioid-free groupDrug
We'll study if the opioid-free anesthesia can reduce the biochemical recurrence of prostate cancer.
Opioid GroupDrug
This group will receive fentanyl in the induction of anesthesia.
transversus abdominal plane block with ropivacaineProcedure or surgery
The opioid-free group will receive transversus abdominal plane block with ropivacaine 0,375% 20 ml each side
transversus abdominal plane block with placeboProcedure or surgery
the non-opioid free group will receive transversus abdominal plane block with physiological solution 0,9% 20 ml each side
| Study group | Role | What they receive |
|---|---|---|
| Opioid-free | Experimental | The patients of this group will receive opioid-free anesthesia Receives: 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. Receives: Drug: Opioid Group; Procedure: transversus abdominal plane block with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years after the date of the surgery
Secondary outcomes (5)
Neutrophil-to-lymphocyte ratio
Compare the peutrophil-to-lymphocyte ratio preoperatively and with 24 hour postoperatively between the two groups to study about inflammation.
Measured: 24 hour postoperatively
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
Measured: Up to 2 hours postoperatively
Rescue Morphine
compare the total dosis needed for pain at delivery post-anaesthesia care unit
Measured: Up to 2 hours postoperatively
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
Measured: Up to 2 hours postoperatively
adverse outcomes
compare the postoperative adverse outcomes (such as nausea, pruritus, somnolence) between the two groups at delivery of post-anaesthesia care unit
Measured: Up to 2 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start12 Jan 2017
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Rangel, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212456
- Sponsor's protocol ID
- NP 834/15
- Status last verified
- Jul 2020
- First submitted
- 10 Apr 2017
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 33712224
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-operative Biochemical Recurrence in Patients Submitted to Radical Prostatectomy Under General Opioid-free Anesthesia Compared to Conventional General Anesthesia
- ClinicalTrials.gov ID
- NCT03212456
- Acronym / sponsor ID
- NP 834/15
- Conditions
- Prostate Cancer
- Keywords
- general anesthesia, cancer recurrence, opioids analgesics, neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 12 Jan 2017 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid-free | Experimental | Drug: opioid-free group, Procedure: transversus abdominal plane block with ropivacaineThe patients of this group will receive opioid-free anesthesia |
| Non opioid-free | Active comparator | Drug: Opioid Group, Procedure: transversus abdominal plane block with placeboThe 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Prostate Cancer;
- Intermediate to high risk of recurrence by D'Amico criteria (Gleason scale > or = 7; PSA > or = 10)
Key exclusion criteria (4 listed)
- Patient refuse;
- atrioventricular blockade;
- Coagulopathy;
- Other procedure at same time.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| opioid-free groupWe'll study if the opioid-free anesthesia can reduce the biochemical recurrence of prostate cancer. | Drug | Opioid-free |
| Opioid GroupThis group will receive fentanyl in the induction of anesthesia. | Drug | Non opioid-free |
| transversus abdominal plane block with ropivacaineThe opioid-free group will receive transversus abdominal plane block with ropivacaine 0,375% 20 ml each side | Procedure or surgery | Opioid-free |
| transversus abdominal plane block with placebothe non-opioid free group will receive transversus abdominal plane block with physiological solution 0,9% 20 ml each side | Procedure or surgery | Non opioid-free |
Primary outcome
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.
5 secondary outcomes
Neutrophil-to-lymphocyte ratio
Time frame: 24 hour postoperatively
visual analogue pain score in the post-anaesthesia care unit
Time frame: Up to 2 hours postoperatively
Rescue Morphine
Time frame: Up to 2 hours postoperatively
Satisfaction with anesthesia technique
Time frame: Up to 2 hours postoperatively
adverse outcomes
Time frame: Up to 2 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Derived from this study: PubMed 33712224Rangel 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing opioid-free group, Opioid Group and transversus abdominal plane block with ropivacaine in people with Prostate Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical recurrence of prostate cancer (time frame: Up to 2 years after the date of the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03212456, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.