AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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 groups in NCT03884335
Study groupRoleWhat they receive
epidural groupActive comparatorAn 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 groupExperimentalBilateral 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.

  1. 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)
  1. Need for postoperative analgesic medication

    milligrams of morphine administered

    Measured: up to 6 hours after surgery

  2. Postoperative recovery

    time to bowel movement (first flatus after surgery)

    Measured: up to 24 hours postoperatively

  3. 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.

  1. First posted21 Mar 2019
  2. Study start1 Oct 2016
  3. Primary completion1 May 2018
  4. Study completion18 Jul 2018

Resources

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)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in