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TAP Block for Open Radical Prostatectomy.

Primary Purpose

Opioid Consumption, Incidence of Nausea and Vomiting, Postoperative Pain

Status
Terminated
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Normal saline via TAP catheters
Lidocaine via TAP catheters
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Consumption

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • McGill University Health Centre, Montreal General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

TAP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Postoperative morphine consumption

Secondary Outcome Measures

Incidence of nausea and vomiting
VRS for pain at rest, during ambulation and coughing
Assessment of recovery
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

Full Information

First Posted
June 30, 2010
Last Updated
March 16, 2015
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01157546
Brief Title
TAP Block for Open Radical Prostatectomy.
Official Title
Continuous Transversus Abdominis Plane (TAP) Block for Open Radical Prostatectomy. A Double Blind Randomized Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment rate. In our center, open radical prostatectomies have been almost completely replaced by robotic prostatectomies.
Study Start Date
August 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Consumption, Incidence of Nausea and Vomiting, Postoperative Pain, Assessment of Recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
TAP
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Normal saline via TAP catheters
Other Intervention Name(s)
0.9% normal saline, NSS
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lidocaine via TAP catheters
Other Intervention Name(s)
Xylocaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative morphine consumption
Time Frame
at 24 hour after surgery
Secondary Outcome Measure Information:
Title
Incidence of nausea and vomiting
Time Frame
at 2, 12, 24 and 48 hour after surgery
Title
VRS for pain at rest, during ambulation and coughing
Time Frame
at 2, 12, 24 and 48 hour after surgery
Title
Assessment of recovery
Description
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.
Time Frame
at 24 hours after the surgery and every 24 hours until patients are discharged.
Title
Postoperative morphine consumption
Time Frame
at 2, 12 and 48 hours after surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco Carli, Professor
Organizational Affiliation
McGill University Healt Centre, Department of Anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Centre, Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada

12. IPD Sharing Statement

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TAP Block for Open Radical Prostatectomy.

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