TAP Block for Open Radical Prostatectomy.

This study has suspended participant recruitment.
(Low recruitment rate. In our center, open radical prostatectomies have been almost completely replaced by robotic prostatectomies.)
Sponsor:
Information provided by (Responsible Party):
Gabriele Baldini, Assistant Professor, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01157546
First received: June 30, 2010
Last updated: March 18, 2013
Last verified: March 2013

June 30, 2010
March 18, 2013
August 2010
December 2013   (final data collection date for primary outcome measure)
Postoperative morphine consumption [ Time Frame: at 24 hour after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01157546 on ClinicalTrials.gov Archive Site
  • Incidence of nausea and vomiting [ Time Frame: at 2, 12, 24 and 48 hour after surgery ] [ Designated as safety issue: No ]
  • VRS for pain at rest, during ambulation and coughing [ Time Frame: at 2, 12, 24 and 48 hour after surgery ] [ Designated as safety issue: No ]
  • Assessment of recovery [ Time Frame: at 24 hours after the surgery and every 24 hours until patients are discharged. ] [ Designated as safety issue: No ]
    Assessment of recovery (two-minute walking test, Miles scale) and time out of bed (sitting or walking will be measured every day until hospital discharge.
  • Postoperative morphine consumption [ Time Frame: at 2, 12 and 48 hours after surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
TAP Block for Open Radical Prostatectomy.
Continuous Transversus Abdominis Plane (TAP) Block for Open Radical Prostatectomy. A Double Blind Randomized Study.

This is a prospective, double blind, randomized study is proposed in patients undergoing open radical prostatectomy: its objective is to establish whether continuous bilateral TAP blocks would provide adequate perioperative analgesia, decrease opioid consumption, reduce the incidence of opioid-related side effects, and facilitate surgical recovery (in terms of PACU and hospital discharge).

Open prostatectomy is a surgical procedure performed by urologists to excise the prostate. This is achieved by a 10-cm vertical incision starting below the umbilicus and reaching the pubic area. Patients are hospitalized for 3-4 days: one of the criteria for safe discharge includes Visual Analogue Scale (VAS) for pain below 3 at rest. For postoperative pain control, patients receive patient-controlled opioid analgesia (PCA) with morphine. The average amount of morphine used in the first 24 h varies between 30 and 50 mg. Although this technique is widely used, side effects (sedation, ileus, pruritus) are commonly encountered with opioid administration. Thus alternative analgesic techniques such as epidural analgesia and wound infiltration have been used with some success. However adverse events have also been reported with these techniques (lower limb motor block with epidural; infection wound infiltration).

In the last 10 years, a new technique, the transversus abdominis plane (TAP) block, which anesthetizes the thoracolumbar nerves (intercostal, subcostal and first lumbar nerves), has been described. The thoracolumbar nerves provide sensory innervation to the anterolateral abdominal wall. The traditional technique for TAP blocks is performed with a blunt needle in the Triangle of Petit. The latter is delineated caudally by the iliac crest, posteriorly by the latissimus muscle and anteriorly by the external oblique. Two distinct pops can be felt as the needle crosses the fascial extensions of the external oblique and the internal oblique muscle, respectively. Thus the second pop usually signifies that the needle tip has reached the TAP. Although the traditional technique has been used to provide postoperatively analgesia for bowel surgery, hysterectomy and Cesarian Section, the position of the Triangle of Petit varies greatly thus making it difficult to palpate in obese patients. In 2007, there was a study describing an ultrasound-guided technique for TAP blocks: these authors advocated using ultrasonography to locate the TAP along the mid-axillary line above the iliac crest. This ultrasound-guided technique has been subsequently used to provide postoperative analgesia for laparoscopic cholecystectomy, appendicectomy and Cesarian Section. This technique has been shown to spare opioids in the postoperative period therefore facilitating an accelerated discharge and superior pain relief.

In our institution, the TAP block, either as a single shot or as a continuous catheter infusion, is used for abdominal and urological surgery when epidural blockade is not feasible.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Opioid Consumption
  • Incidence of Nausea and Vomiting
  • Postoperative Pain
  • Assessment of Recovery
  • Procedure: Normal saline via TAP catheters
    A bolus of normal saline (20 mL per side) followed by a continuous infusion of normal saline (7 ml/h per side. The infusions will be started after the bolus doses and continued postoperatively for 48 hours.
    Other Names:
    • 0.9% normal saline
    • NSS
  • Procedure: Lidocaine via TAP catheters
    A bolus of lidocaine 1% with epinephrine 1:200 000 (20 mL per side) followed by a continuous infusion of ropivacaine 0.2% (7 mL/h per side). The infusions will be started after the bolus doses and continued postoperatively for 48 hours.
    Other Name: Xylocaine
  • Placebo Comparator: Control
    group A (control) will receive a bolus of normal saline (20 mL per side) followed by a continuous infusion of normal saline (7 ml/h per side) via both TAP catheters.The infusions will be started after the bolus doses and continued postoperatively for 48 hours.
    Intervention: Procedure: Normal saline via TAP catheters
  • Experimental: TAP
    group B (TAP) will receive a bolus of lidocaine 1% with epinephrine 1:200 000 (20 mL per side) followed by a continuous infusion of ropivacaine 0.2% (7 mL/h per side) via TAP catheters. The infusions will be started after the bolus doses and continued postoperatively for 48 hours.
    Intervention: Procedure: Lidocaine via TAP catheters
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
42
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age: 18 years and over
  • ASA class 1, 2
  • Elective open radical prostatectomy

Exclusion Criteria:

  • Any history or signs of cardiac, hepatic and renal failure. Patients with raised serum LFTs and serum creatinine outside normal range
  • Any chronic use of opioid analgesic
  • Morbid obesity (BMI>40)
  • History of allergic reactions to any of the study medications and the medications used for the trial
  • Pregnancy
  • Previous abdominal surgery
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01157546
GEN-10-012
Yes
Gabriele Baldini, Assistant Professor, McGill University Health Center
McGill University Health Center
Not Provided
Principal Investigator: Franco Carli, Professor McGill University Healt Centre, Department of Anesthesia
McGill University Health Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP