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
  Purpose

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).


Condition Intervention Phase
Opioid Consumption
Incidence of Nausea and Vomiting
Postoperative Pain
Assessment of Recovery
Procedure: Normal saline via TAP catheters
Procedure: Lidocaine via TAP catheters
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Continuous Transversus Abdominis Plane (TAP) Block for Open Radical Prostatectomy. A Double Blind Randomized Study.

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Postoperative morphine consumption [ Time Frame: at 24 hour after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 42
Study Start Date: August 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01157546

Locations
Canada, Quebec
McGill University Health Centre, Montreal General Hospital
Montreal, Quebec, Canada, H3G1A4
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Franco Carli, Professor McGill University Healt Centre, Department of Anesthesia
  More Information

No publications provided

Responsible Party: Gabriele Baldini, Assistant Professor, MD, Assistant Professor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01157546     History of Changes
Other Study ID Numbers: GEN-10-012
Study First Received: June 30, 2010
Last Updated: March 18, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Pain, Postoperative
Vomiting
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014