- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01157546
TAP Block for Open Radical Prostatectomy.
Continuous Transversus Abdominis Plane (TAP) Block for Open Radical Prostatectomy. A Double Blind Randomized Study.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Quebec
-
Montreal, Quebec, Canada, H3G1A4
- McGill University Health Centre, Montreal General Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: 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.
Andre navne:
|
|
Eksperimentel: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Postoperative morphine consumption
Tidsramme: at 24 hour after surgery
|
at 24 hour after surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of nausea and vomiting
Tidsramme: 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
Tidsramme: at 2, 12, 24 and 48 hour after surgery
|
at 2, 12, 24 and 48 hour after surgery
|
|
|
Assessment of recovery
Tidsramme: 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
Tidsramme: at 2, 12 and 48 hours after surgery
|
at 2, 12 and 48 hours after surgery
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Franco Carli, Professor, McGill University Healt Centre, Department of Anesthesia
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Tegn og symptomer, fordøjelsessystemet
- Opkastning
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-arytmimidler
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Sensoriske systemagenter
- Bedøvelsesmidler
- Membrantransportmodulatorer
- Bedøvelsesmidler, lokale
- Spændingsstyret natriumkanalblokkere
- Natriumkanalblokkere
- Lidokain
Andre undersøgelses-id-numre
- GEN-10-012
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