ProstatectomyNCT03884335
Radical Laparoscopic Prostatectomy. Enhanced Recovery After Surgery (ERAS) Program
A study testing laparoscopic radical prostatectomy in people with Prostatectomy, run by Consorci Sanitari Integral.
Trial summary
Current trends are based on the implementation of enhanced recovery programs (ERP) for most surgical procedures. The transversus abdominis plane (TAP) block has been demonstrated as an effective analgesic alternative in abdominal surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostatectomy
- What is being tested?
- laparoscopic radical prostatectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 18 Jul 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing laparoscopic radical prostatectomy
Who cannot join
- anaesthesia ASA score ≥IV;
- body mass index (BMI) ≥30 Kg/m2;
- history of local anaesthesic (LA) allergies, -
- chronic opioid use,
- coagulation alterations (including heparin treatment)
- peripheral neuropathy;
- reconversion to open surgery;
- patient's refusal of consent
About this study
Official title: Comparison Between Epidural Technique and Mid-axillary Ultrasound-guided TAP Block for Postoperative Analgesia of Laparoscopic Radical Prostatectomy. Impact on Early Discharge
Current trends are based on the implementation of enhanced recovery programs (ERP) for most surgical procedures. The transversus abdominis plane (TAP) block has been demonstrated as an effective analgesic alternative in abdominal surgeries. The goal of this study was to compare analgesic efficacy of the TAP block against epidural technique in patients who underwent laparoscopic radical prostatectomy (LRP) surgery in an ERP setting. This study was performed between October 2016 and May 2018
Read the detailed description
After approval from Institutional Review Board (approval number 16/42) and compliance with the Declaration of Helsinki; and complying with the information checklist of Consolidated Standards of Reporting trials (CONSORT), informed consent was obtained from all those patients who underwent LRP between October 2016 and May 2018.
Exclusion criteria were: age below 18 years old; American Society of Anaesthesiologists (ASA) score ≥IV; body mass index (BMI) ≥30 Kg/m-2; history of local anaesthetic (LA) allergies; chronic opioid use, coagulopathy; peripheral neuropathy; reconversion to open surgery; or patient's refusal of consent.
Patients were randomized to either TAP or epidural group according to sequential recruitment criteria performed at the pre-operative visit. At this point, age, anaesthesia ASA score and BMI was also recorded.
Management of patients undergoing LRP - intraoperatively All patients underwent combined anaesthesia: either general anaesthesia + epidural; or general anaesthesia + TAP block (TAP group). Patients were premedicated with intravenous midazolam 0.05 mg/Kg-1. In the epidural group, a catheter was placed at L1-L2 level, and tested, prior to induction. Induction was performed intravenously with fentanyl (1.5 mcg/Kg-1), propofol (1.5-2 mg/Kg-1), and rocuronium (0.6 mg/Kg-1). Orotracheal intubation was performed. Prior to skin incision 8 mL of 0.25% levo-bupivacaine were administered epidurally, and a continuous perfusion of 0.125% levo-bupivacaine at 5 mL was started. In the TAP group, a bilateral, ultrasound-guided mid-axillary TAP block was performed immediately after induction (the same as epidural group) but prior to surgery. The high-frequency lineal probe (Sonosite MicroMAXXTM) was placed midway between the costal margin and iliac crest, and transversus abdominis muscle (TAM) located behind the rectus abdominis and below the internal oblique muscle (IOM). 20 mL of LA (bupivacaine 0.375%) was administered via a 22-gauge Quincke spinal needle inserted in-plane on each side of the abdomen. A block was considered successful whenever interfascial local anaesthetic spread was evident under ultrasound vision.
A laparoscopic radical prostatectomy was performed. Intraoperative anaesthetic maintenance was performed with propofol target-controlled infusion (TCI) for bispectral index between 40 and 60. Net zero fluid therapy was maintained, as well as normothermia, normotension and optimal intraoperative analgesia following ERP criteria. After surgery, patients were awoken from general anaesthesia and transferred to the post-anaesthesia care unit (PACU) for a 6-hour follow-up prior to transfer to conventional ward.
The following data was recorded during the intraoperative period: hemodynamic and respiratory parameters, complications related to analgesic technique (vascular puncture, peritoneal or intestinal puncture in the TAP block, number of attempts, impossibility to perform technique), surgery-related complications (bleeding, intestinal, bladder or diaphragmatic perforation), and length of surgery.
Management of patients undergoing LRP - PACU. In the PACU, the patient was kept under observation for 6 hours for pain and bleeding control, as well as hemodynamic and respiratory management. Besides epidural or TAP blockade, standard analgesia was maintained with paracetamol 1g/8h/iv alternate with metamizole 2 g/8h/iv, as well as 2 mg bolus of morphine, if required. If pain was unmanageable, in the epidural group the first option was administration of 8 mL of 0.125% levo-bupivacaine, secondly catheter was re-positioned, and if these options failed, catheter was removed and a morphine infusion was begun. In the TAP group, if rescue morphine bolus (of up to 10mg) was not enough, TAP-block was repeated. If after 20 minutes the patient showed no improvement, morphine infusion was begun. In these cases (both epidural and TAP groups), data was considered as analgesic technique failure.
The following data was recorded during the PACU period: pain as evaluated by the visual analogue scale (VAS) upon rest (VASr) and movement -cough- (VASm) at 1, 2, 3, 4, and 6 hours; mg of morphine administered; failure of analgesic technique (need of morphine PCA); surgical complications; analgesic technique complications (motor blockade, paraesthesias, accidental catheter disconnection); hydric tolerance; postoperative nausea or vomiting (PONV); and time to bowel movement (first flatus after surgery).
Management of patients undergoing LRP - Hospital Ward. After PACU, patients were transferred to conventional hospital ward. During this period, they were followed-up by the hospital's acute pain team, formed by an anaesthesiologist and a specialized nurse.
The following data was registered during this period: VASr and VASm at 12, 18, 24, 36, and 48 hours; time to sitting position and perambulation; PONV; complications of surgical and anaesthetic technique (including infection at this point); mg of morphine administered; failure of analgesic technique (need of morphine PCA); and length of in-hospital stay.
- Conditions
- Prostatectomy
- Being tested
- laparoscopic radical prostatectomy
- Keywords
- Epidural analgesia, Transversus abdominis plane blockade, Laparoscopic prostatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic radical prostatectomyProcedure or surgery
The surgery was carried out by laparoscopy. Intraoperative anesthetic maintenance was performed with TCI of propofol infusion for bispectral index between 40 and 60, restrictive administration of fluids or goal-directed parenteral fluid administration, normothermia, normotension and optimal intraoperative analgesia were maintained following the criteria of ERP. Afterwards, patients were awoken from general anaesthesia and transferred to the post-anaesthesia care unit (PACU) for a 6-hour follow-up prior to transfer to conventional ward.
| Study group | Role | What they receive |
|---|---|---|
| epidural group | Active comparator | An epidural catheter was placed at L1-L2 level, and tested, prior to induction. Induction was performed intravenously with fentanyl (1.5mcg•Kg-1), propofol (1.5-2 mg•Kg-1), and rocuronium (0.6 mg•Kg-1). Orotracheal intubation was performed. Prior to skin incision 8 mL of 0.25% levo-bupivacaine were administered epidurally, and a continuous perfusion of 0.125% levo-bupivacaine at 5 mL was started. Receives: Procedure: laparoscopic radical prostatectomy |
| TAP group | Experimental | Bilateral Transversus abdominis plane blockade (TAP) was performed following induction of anaesthesia ( the same of epidural group) and prior to skin incision, the high-frequency lineal probe (Sonosite MicroMAXXTM) was placed midway between the costal margin and iliac crest, and transversus abdominis muscle located behind the rectus abdominis and below the IOM. 20 mL of LA (bupivacaine 0.375%) was administered via a 22 gauge Quincke spinal needle inserted in-plane on each side of the abdomen. A successful block was recorded if the plane was seen to expand with fluid under ultrasound vision. Receives: Procedure: laparoscopic radical prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of postoperative pain over time
Pain was evaluated by the visual analogue scale (VAS) upon rest (VASr) and movement -cough- (VASm) at postanesthesia care unit and in the hospital ward. VAS ranges from 0 (no pain) to 10 (maximum pain).
Measured: Pain was assessed at 1 hour, 2 hours, 3 hours, 4 hours, and 6 hours, and then 12 hours,18 hours, 24 hours, 36 hours and 48 hours
Secondary outcomes (3)
Need for postoperative analgesic medication
milligrams of morphine administered
Measured: up to 6 hours after surgery
Postoperative recovery
time to bowel movement (first flatus after surgery)
Measured: up to 24 hours postoperatively
Evolution till hospital discharge
time to sitting position and perambulation
Measured: up to 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Oct 2016
- Primary completion1 May 2018
- Study completion18 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstatectomyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari Integral
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884335
- Sponsor's protocol ID
- 16/42
- Status last verified
- Mar 2019
- First submitted
- 12 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Epidural Technique and Mid-axillary Ultrasound-guided TAP Block for Postoperative Analgesia of Laparoscopic Radical Prostatectomy. Impact on Early Discharge
- ClinicalTrials.gov ID
- NCT03884335
- Acronym / sponsor ID
- 16/42
- Conditions
- Prostatectomy
- Keywords
- Epidural analgesia, Transversus abdominis plane blockade, Laparoscopic prostatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Consorci Sanitari IntegralUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 21 Mar 2019 (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.
Current trends are based on the implementation of enhanced recovery programs (ERP) for most surgical procedures. The transversus abdominis plane (TAP) block has been demonstrated as an effective analgesic alternative in abdominal surgeries. The goal of this study was to compare analgesic efficacy of the TAP block against epidural technique in patients who underwent laparoscopic radical prostatectomy (LRP) surgery in an ERP setting. This study was performed between October 2016 and May 2018
Detailed description
After approval from Institutional Review Board (approval number 16/42) and compliance with the Declaration of Helsinki; and complying with the information checklist of Consolidated Standards of Reporting trials (CONSORT), informed consent was obtained from all those patients who underwent LRP between October 2016 and May 2018.
Exclusion criteria were: age below 18 years old; American Society of Anaesthesiologists (ASA) score ≥IV; body mass index (BMI) ≥30 Kg/m-2; history of local anaesthetic (LA) allergies; chronic opioid use, coagulopathy; peripheral neuropathy; reconversion to open surgery; or patient's refusal of consent.
Patients were randomized to either TAP or epidural group according to sequential recruitment criteria performed at the pre-operative visit. At this point, age, anaesthesia ASA score and BMI was also recorded.
Management of patients undergoing LRP - intraoperatively All patients underwent combined anaesthesia: either general anaesthesia + epidural; or general anaesthesia + TAP block (TAP group). Patients were premedicated with intravenous midazolam 0.05 mg/Kg-1. In the epidural group, a catheter was placed at L1-L2 level, and tested, prior to induction. Induction was performed intravenously with fentanyl (1.5 mcg/Kg-1), propofol (1.5-2 mg/Kg-1), and rocuronium (0.6 mg/Kg-1). Orotracheal intubation was performed. Prior to skin incision 8 mL of 0.25% levo-bupivacaine were administered epidurally, and a continuous perfusion of 0.125% levo-bupivacaine at 5 mL was started. In the TAP group, a bilateral, ultrasound-guided mid-axillary TAP block was performed immediately after induction (the same as epidural group) but prior to surgery. The high-frequency lineal probe (Sonosite MicroMAXXTM) was placed midway between the costal margin and iliac crest, and transversus abdominis muscle (TAM) located behind the rectus abdominis and below the internal oblique muscle (IOM). 20 mL of LA (bupivacaine 0.375%) was administered via a 22-gauge Quincke spinal needle inserted in-plane on each side of the abdomen. A block was considered successful whenever interfascial local anaesthetic spread was evident under ultrasound vision.
A laparoscopic radical prostatectomy was performed. Intraoperative anaesthetic maintenance was performed with propofol target-controlled infusion (TCI) for bispectral index between 40 and 60. Net zero fluid therapy was maintained, as well as normothermia, normotension and optimal intraoperative analgesia following ERP criteria. After surgery, patients were awoken from general anaesthesia and transferred to the post-anaesthesia care unit (PACU) for a 6-hour follow-up prior to transfer to conventional ward.
The following data was recorded during the intraoperative period: hemodynamic and respiratory parameters, complications related to analgesic technique (vascular puncture, peritoneal or intestinal puncture in the TAP block, number of attempts, impossibility to perform technique), surgery-related complications (bleeding, intestinal, bladder or diaphragmatic perforation), and length of surgery.
Management of patients undergoing LRP - PACU. In the PACU, the patient was kept under observation for 6 hours for pain and bleeding control, as well as hemodynamic and respiratory management. Besides epidural or TAP blockade, standard analgesia was maintained with paracetamol 1g/8h/iv alternate with metamizole 2 g/8h/iv, as well as 2 mg bolus of morphine, if required. If pain was unmanageable, in the epidural group the first option was administration of 8 mL of 0.125% levo-bupivacaine, secondly catheter was re-positioned, and if these options failed, catheter was removed and a morphine infusion was begun. In the TAP group, if rescue morphine bolus (of up to 10mg) was not enough, TAP-block was repeated. If after 20 minutes the patient showed no improvement, morphine infusion was begun. In these cases (both epidural and TAP groups), data was considered as analgesic technique failure.
The following data was recorded during the PACU period: pain as evaluated by the visual analogue scale (VAS) upon rest (VASr) and movement -cough- (VASm) at 1, 2, 3, 4, and 6 hours; mg of morphine administered; failure of analgesic technique (need of morphine PCA); surgical complications; analgesic technique complications (motor blockade, paraesthesias, accidental catheter disconnection); hydric tolerance; postoperative nausea or vomiting (PONV); and time to bowel movement (first flatus after surgery).
Management of patients undergoing LRP - Hospital Ward. After PACU, patients were transferred to conventional hospital ward. During this period, they were followed-up by the hospital's acute pain team, formed by an anaesthesiologist and a specialized nurse.
The following data was registered during this period: VASr and VASm at 12, 18, 24, 36, and 48 hours; time to sitting position and perambulation; PONV; complications of surgical and anaesthetic technique (including infection at this point); mg of morphine administered; failure of analgesic technique (need of morphine PCA); and length of in-hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epidural group | Active comparator | Procedure: laparoscopic radical prostatectomyAn epidural catheter was placed at L1-L2 level, and tested, prior to induction. Induction was performed intravenously with fentanyl (1.5mcg•Kg-1), propofol (1.5-2 mg•Kg-1), and rocuronium (0.6 mg•Kg-1). Orotracheal intubation was performed. Prior to skin incision 8 mL of 0.25% levo-bupivacaine were administered epidurally, and a continuous perfusion of 0.125% levo-bupivacaine at 5 mL was started. |
| TAP group | Experimental | Procedure: laparoscopic radical prostatectomyBilateral Transversus abdominis plane blockade (TAP) was performed following induction of anaesthesia ( the same of epidural group) and prior to skin incision, the high-frequency lineal probe (Sonosite MicroMAXXTM) was placed midway between the costal margin and iliac crest, and transversus abdominis muscle located behind the rectus abdominis and below the IOM. 20 mL of LA (bupivacaine 0.375%) was administered via a 22 gauge Quincke spinal needle inserted in-plane on each side of the abdomen. A successful block was recorded if the plane was seen to expand with fluid under ultrasound vision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing laparoscopic radical prostatectomy
Key exclusion criteria (8 listed)
- anaesthesia ASA score ≥IV;
- body mass index (BMI) ≥30 Kg/m2;
- history of local anaesthesic (LA) allergies, -
- chronic opioid use,
- coagulation alterations (including heparin treatment)
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 |
|---|---|---|
| laparoscopic radical prostatectomyThe surgery was carried out by laparoscopy. Intraoperative anesthetic maintenance was performed with TCI of propofol infusion for bispectral index between 40 and 60, restrictive administration of fluids or goal-directed parenteral fluid administration, normothermia, normotension and optimal intraoperative analgesia were maintained following the criteria of ERP. Afterwards, patients were awoken from general anaesthesia and transferred to the post-anaesthesia care unit (PACU) for a 6-hour follow-up prior to transfer to conventional ward. | Procedure or surgery | TAP group, epidural group |
Primary outcome
Evolution of postoperative pain over time
Time frame: Pain was assessed at 1 hour, 2 hours, 3 hours, 4 hours, and 6 hours, and then 12 hours,18 hours, 24 hours, 36 hours and 48 hours
Pain was evaluated by the visual analogue scale (VAS) upon rest (VASr) and movement -cough- (VASm) at postanesthesia care unit and in the hospital ward. VAS ranges from 0 (no pain) to 10 (maximum pain).
3 secondary outcomes
Need for postoperative analgesic medication
Time frame: up to 6 hours after surgery
Postoperative recovery
Time frame: up to 24 hours postoperatively
Evolution till hospital discharge
Time frame: up to 48 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic radical prostatectomy in people with Prostatectomy, run by Consorci Sanitari Integral.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evolution of postoperative pain over time (time frame: Pain was assessed at 1 hour, 2 hours, 3 hours, 4 hours, and 6 hours, and then 12 hours,18 hours, 24 hours, 36 hours and 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2019.