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TAP Block for Open Radical Prostatectomy.

16 mars 2015 uppdaterad av: Gabriele Baldini, MD, MSc, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre

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).

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

25

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Quebec
      • Montreal, Quebec, Kanada, H3G1A4
        • McGill University Health Centre, Montreal General Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: 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.
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.
Andra namn:
  • 0,9% normal koksaltlösning
  • NSS
Experimentell: 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.
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.
Andra namn:
  • Xylokain

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Postoperative morphine consumption
Tidsram: at 24 hour after surgery
at 24 hour after surgery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of nausea and vomiting
Tidsram: at 2, 12, 24 and 48 hour after surgery
at 2, 12, 24 and 48 hour after surgery
VRS for pain at rest, during ambulation and coughing
Tidsram: at 2, 12, 24 and 48 hour after surgery
at 2, 12, 24 and 48 hour after surgery
Assessment of recovery
Tidsram: at 24 hours after the surgery and every 24 hours until patients are discharged.
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.
at 24 hours after the surgery and every 24 hours until patients are discharged.
Postoperative morphine consumption
Tidsram: at 2, 12 and 48 hours after surgery
at 2, 12 and 48 hours after surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Franco Carli, Professor, McGill University Healt Centre, Department of Anesthesia

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2010

Primärt slutförande (Faktisk)

1 mars 2013

Avslutad studie (Faktisk)

1 mars 2013

Studieregistreringsdatum

Först inskickad

30 juni 2010

Först inskickad som uppfyllde QC-kriterierna

6 juli 2010

Första postat (Uppskatta)

7 juli 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

17 mars 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 mars 2015

Senast verifierad

1 mars 2015

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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