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- Klinische proef NCT01144273
Transversus Abdominis Plane Block From Abdominal Approach
Transversus Abdominis Plane Block From Intraabdominal Approach in Patients Undergoing Total Abdominal Hysterectomy: a Randomized Controlled Trial
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Kowloon
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Kwun Tong, Kowloon, Hongkong
- Werving
- Department Of Anaesthesiology, Pain medicine and Operating Services. United Christian Hospital
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Contact:
- Wing Yee Lillian Choy, MBBS (HK)
- Telefoonnummer: 3513 4245
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Hoofdonderzoeker:
- Wing Yee Lillian Choy, MBBS (HK)
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Onderonderzoeker:
- Huey Sing Lim, FANZCA,FHKCA
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Onderonderzoeker:
- Man Shun Law, FHKCA,FHKAM
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- ASA physical status I-III
- Age 18 or above
- Scheduled to undergo TAH+/- salpingoophorectomy.
- Scheduled to receive general anaesthesia under standardized anaesthetic regime.
- Comprehends how to use intravenous patient controlled analgesia (IV PCA).
- Is willing to complete the postoperative assessment.
- Understands the nature and purpose of this study and the study procedures and has signed the informed consent form for this study to indicate this understanding.
Exclusion Criteria:
- Known allergy to drugs involved in this study
- Previously taking medications thought to result in opioid tolerance, or analgesics thought to interfere with subsequent opioid requirement.
- Undergoing any procedures in addition to TAH+/- salpingoophorectomy.
- With co-existing pathology resulting in persistent pain requiring analgesics.
- Wound incision extending to supra-umbilical level.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 0.5% Ropivacaine
group receiving TAP block (0.5% ropivacaine at TAP plane)
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This intraabdominal approach to TAP block is being used regularly by gynaecological surgeons in this hospital now. To be performed bilaterally before surgical wound closure by an experienced surgeon who initially undergo initial observation by investigator to ensure uniformity in technique. Local anaesthetic or placebo solution will be injected to TAP with blunt needle from within abdominal cavity under visual and tactile guidance at the triangle of Petit, after feeling one 'pop' through the transversus abdominis muscle to the TAP layer. After careful aspiration to exclude vascular puncture, 1.5mg/kg of 0.5% ropivacaine or 0.3ml/kg of 0.9% saline placebo will be injected to each side slowly while observing for signs of toxicity.
Andere namen:
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Placebo-vergelijker: normal saline
group receiving placebo (saline) at TAP plane
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This intraabdominal approach to TAP block is being used regularly by gynaecological surgeons in this hospital now. To be performed bilaterally before surgical wound closure by an experienced surgeon who initially undergo initial observation by investigator to ensure uniformity in technique. Local anaesthetic or placebo solution will be injected to TAP with blunt needle from within abdominal cavity under visual and tactile guidance at the triangle of Petit, after feeling one 'pop' through the transversus abdominis muscle to the TAP layer. After careful aspiration to exclude vascular puncture, 1.5mg/kg of 0.5% ropivacaine or 0.3ml/kg of 0.9% saline placebo will be injected to each side slowly while observing for signs of toxicity.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
postoperative 24hr morphine consumption
Tijdsspanne: 24 hours
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The primary objective of this study is to demonstrate the effectiveness of tranversus abdominis plane block using the intraabdominal approach in reducing postoperative 24 hours morphine consumption after total abdominal hysterectomy (TAH) where time 0 is taken as time of arrival at PACU.
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24 hours
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
morphine consumption on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after.
Tijdsspanne: 24hrs
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• Assess and compare the morphine consumption on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after.
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24hrs
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Degree on pain according to numerical pain score on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after during rest and movement (cough
Tijdsspanne: 24hrs
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24hrs
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incidence of nausea and vomiting
Tijdsspanne: 24hours postoperatively
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24hours postoperatively
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Wing Yee Lillian Choy, MBBS (HK), United Christian Hospital, Hospital Authority
Publicaties en nuttige links
Algemene publicaties
- McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
- Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
- Bonnet F, Berger J, Aveline C. Transversus abdominis plane block: what is its role in postoperative analgesia? Br J Anaesth. 2009 Oct;103(4):468-70. doi: 10.1093/bja/aep243. No abstract available.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- Protocol ver 1.1
- KC/KE-10-0021/FR-3 (Andere identificatie: Research Ethics committee (Kowloon Central/Kowloon East))
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Transversus Abdominis Plane Block From Abdominal Approach
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Istanbul Medeniyet UniversityWervingSubcostal Transversus Abdominis Plane BlockKalkoen
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Icahn School of Medicine at Mount SinaiVoltooidLaparoscopische sleeve gastrectomie | Subcostal Transversus Abdominis Plane BlockVerenigde Staten
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Al-Azhar UniversityWervingAcute pijn | Keizersnede | Bupivacaine | Ultrasound Guided Transversus Abdominis Plane Block | Chirurgisch transversus abdominis-vliegtuigblokEgypte
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Sisli Hamidiye Etfal Training and Research HospitalVoltooidPostoperatieve pijn | Galblaas ziekte | Subcostal Transversus Abdominis Plane BlockKalkoen
Klinische onderzoeken op Transversus abdominis plane block
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Bakirkoy Dr. Sadi Konuk Research and Training HospitalVoltooidPostoperatieve complicaties | Postoperatieve pijn | Analgesie | Regionale anesthesie morbiditeitKalkoen
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Ataturk UniversityVoltooid
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Tribhuvan University Teaching Hospital, Institute...Nog niet aan het werven
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Institut Jean-GodinotGeschorstPijn, postoperatiefFrankrijk
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Istanbul Saglik Bilimleri UniversityVoltooidPijn, postoperatief | Keizersnede | Erector Spinae vliegtuigblok | Transversus Abdominis-vlakblokKalkoen
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University of OuluAlgemeen Ziekenhuis Maria MiddelaresVoltooid
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Mackay Memorial HospitalWervingLaparoscopie | Anesthesie en analgesie | Autonoom zenuwstelsel | Zenuw blok | EEGTaiwan
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Fatih Sultan Mehmet Training and Research HospitalNog niet aan het wervenPostoperatieve pijn | Inguinale hernia | Transversus Abdominis-vlakblokKalkoen
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City Clinical Hospital No.1 named after N.I. PirogovPirogov Russian National Research Medical UniversityNog niet aan het wervenIncisiehernia van de middellijn van de buikRussische Federatie
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Khon Kaen UniversityWervingMorbide obesitas | Opioïde gebruik | Laparoscopische sleeve gastrectomie | Transversus Abdominis-vlakblok | Lokale wondinfiltratie | BupivacineThailand