TAP Block for Open Radical Prostatectomy.
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. |
- Postoperative morphine consumption [ Time Frame: at 24 hour after surgery ] [ Designated as safety issue: No ]
- 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:
|
|
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 |
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| Canada, Quebec | |
| McGill University Health Centre, Montreal General Hospital | |
| Montreal, Quebec, Canada, H3G1A4 | |
| 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 May 22, 2013