TAP Block for Open Radical Prostatectomy.

NCT ID: NCT01157546

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2013-03-31

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.

Conditions

Opioid Consumption; Incidence of Nausea and Vomiting; Postoperative Pain; Assessment of Recovery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Normal saline via TAP catheters

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

Lidocaine via TAP catheters

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

0.9% normal saline; NSS; Xylocaine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Gabriele Baldini, MD, MSc, Assistant Professor

MD, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Franco Carli, Professor

Role: PRINCIPAL_INVESTIGATOR

McGill University Healt Centre, Department of Anesthesia

Locations

McGill University Health Centre, Montreal General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

GEN-10-012

Identifier Type: -

Identifier Source: org_study_id