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Radical Laparoscopic Prostatectomy. Enhanced Recovery After Surgery (ERAS) Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884335
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Consorci Sanitari Integral

Brief 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. 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

Condition or disease Intervention/treatment Phase
Prostatectomy Procedure: laparoscopic radical prostatectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Epidural Technique and Mid-axillary Ultrasound-guided TAP Block for Postoperative Analgesia of Laparoscopic Radical Prostatectomy. Impact on Early Discharge
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : July 18, 2018

Arm Intervention/treatment
Active Comparator: epidural group
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.
Procedure: laparoscopic radical prostatectomy
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.

Experimental: TAP group
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.
Procedure: laparoscopic radical prostatectomy
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Need for postoperative analgesic medication [ Time Frame: up to 6 hours after surgery ]
    milligrams of morphine administered

  2. Postoperative recovery [ Time Frame: up to 24 hours postoperatively ]
    time to bowel movement (first flatus after surgery)

  3. Evolution till hospital discharge [ Time Frame: up to 48 hours postoperatively ]
    time to sitting position and perambulation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing laparoscopic radical prostatectomy

Exclusion Criteria:

  • 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
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Responsible Party: Consorci Sanitari Integral
ClinicalTrials.gov Identifier: NCT03884335    
Other Study ID Numbers: 16/42
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

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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 Consorci Sanitari Integral:
Epidural analgesia
Transversus abdominis plane blockade
Laparoscopic prostatectomy