NCT03884335

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

1.6 years

First QC Date

March 12, 2019

Last Update Submit

March 22, 2019

Conditions

Prostatectomy

Keywords

Epidural analgesiaTransversus abdominis plane blockadeLaparoscopic prostatectomy

Outcome Measures

Primary Outcomes (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).

    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

    up to 6 hours after surgery

  • Postoperative recovery

    up to 24 hours postoperatively

  • Evolution till hospital discharge

    up to 48 hours postoperatively

Study Arms (2)

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.

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.

Procedure: laparoscopic radical prostatectomy

Interventions

laparoscopic radical prostatectomyPROCEDURE

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.

TAP groupepidural group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing laparoscopic radical prostatectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 21, 2019

Study Start

October 1, 2016

Primary Completion

May 1, 2018

Study Completion

July 18, 2018

Last Updated

March 26, 2019

Record last verified: 2019-03