- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02197988
TAP Versus Thoracic Epidural in Major Abdominal Resections
Efficacy and Safety of Transversus Abdominis Plane Blocks Versus Thoracic Epidural Anesthesia in Patients Undergoing Major Abdominal Resections: A Prospective, Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The purpose of this study is to compare the clinical profiles of two currently acceptable analgesia techniques in terms of incidence of hypotension with subsequent fluid administration and pain control by evaluation of both objective and subjective data. The investigators will also compare any additional hospital costs associated with side effect management related to either analgesia method.
This study is a prospective, randomized, open-label trial. Patients who agree to participate and satisfy the inclusion/exclusion criteria will be randomized at the time of enrollment into one of two groups (thoracic epidural or TAP block) using a randomization tool created for the study.
Patients will undergo their scheduled surgery and receive the analgesic method to which they have been randomized. Both methods (thoracic epidural or TAP block) are performed routinely at Spectrum Health and are considered routine care.
Data collected will include medical history and demographics from the patient's medical record. Intraoperative data will include length of surgery, estimated surgical blood loss, complications, blood pressure and medication requirements. Postoperative data will include episodes of hypotension (defined as a systolic BP < 90), fluid requirement in first 24 hours and first 72 hours, pain scores, narcotic usage, return to bowel function (as defined by flatus), time to tolerating a soft or regular diet, and complications. Data will also be collected via a survey each study patient will complete for study purposes only.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Michigan
-
Grand Rapids, Michigan, États-Unis, 49503
- Spectrum Health
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- All patients male or female >18 years old who are scheduled to undergo a major abdominal surgery. Abdominal procedures include, but are not limited to: pancreaticoduodenectomies, distal pancreatectomies, bowel resection, liver resection, esophagectomies, heated intraperitoneal chemotherapy, retroperitoneal excisions and large genitourinary procedures
- Patients determined by their surgeon as medically able to receive a thoracic epidural or a TAP block interchangeably after consideration of both procedures
- Patient agrees to participate in this study and provides informed consent
Exclusion criteria:
- Surgical cases combined with thoracic surgeries
- Surgical cases where the abdominal operation is performed laparoscopically
- Patients that have allergies to lidocaine, bupivacaine, levobupivacaine or hydromorphone
- Patients that are on anticoagulation or antiplatelet medications at time of surgery other than aspirin
- Surgical cases that typically do not require a regional block in addition to general anesthesia (e.g., cutaneous operations)
- Adults unable to provide informed consent
- Children
- Pregnant women
- Prisoners
- Non-English speaking subjects
- Any other medical condition including mental illness or substance abuse deemed by the investigator to be likely to interfere with a subject's ability to provide informed consent, cooperate and take part in this research study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Transversus Abdominis Plane Block
Transversus Abdominis Plane Block Exparel 1.33% (20ml Volume)
|
Transversus Abdominis Plane Block
Autres noms:
|
Comparateur actif: Thoracic Epidural Anesthesia
Thoracic Epidural Anesthesia 0.125% bupivicaine with 2 mcg/ml Fentanyl
|
Thoracic Epidural Anesthesia
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Hypotension
Délai: First 24-72 hours postoperatively
|
The incidence of systolic blood pressure less than 90 mmHg and fluid requirements
|
First 24-72 hours postoperatively
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Patient satisfaction relative to pain control and amount of additional narcotic usage
Délai: Post operative day two during hospitalization
|
A short patient survey during the postoperative period which will collect information on pain management.
|
Post operative day two during hospitalization
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Cost Evaluation
Délai: Postoperative hospitalization an expected average of 6 months
|
Evaluate costs incurred relative to adverse side effect management and pain management related to either the TAP block or thoracic epidural.
|
Postoperative hospitalization an expected average of 6 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mathew Chung, MD, Spectrum Health Hospitals
Publications et liens utiles
Publications générales
- 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.
- Johns N, O'Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. 2012 Oct;14(10):e635-42. doi: 10.1111/j.1463-1318.2012.03104.x.
- Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.
- Taylor R Jr, Pergolizzi JV, Sinclair A, Raffa RB, Aldington D, Plavin S, Apfel CC. Transversus abdominis block: clinical uses, side effects, and future perspectives. Pain Pract. 2013 Apr;13(4):332-44. doi: 10.1111/j.1533-2500.2012.00595.x. Epub 2013 Feb 13.
- Holte K, Foss NB, Svensen C, Lund C, Madsen JL, Kehlet H. Epidural anesthesia, hypotension, and changes in intravascular volume. Anesthesiology. 2004 Feb;100(2):281-6. doi: 10.1097/00000542-200402000-00016.
- Borglum J, Jensen K, Christensen AF, Hoegberg LC, Johansen SS, Lonnqvist PA, Jansen T. Distribution patterns, dermatomal anesthesia, and ropivacaine serum concentrations after bilateral dual transversus abdominis plane block. Reg Anesth Pain Med. 2012 May-Jun;37(3):294-301. doi: 10.1097/AAP.0b013e31824c20a9.
- Abdallah FW, Chan VW, Brull R. Transversus abdominis plane block: a systematic review. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):193-209. doi: 10.1097/AAP.0b013e3182429531.
- Young MJ, Gorlin AW, Modest VE, Quraishi SA. Clinical implications of the transversus abdominis plane block in adults. Anesthesiol Res Pract. 2012;2012:731645. doi: 10.1155/2012/731645. Epub 2012 Jan 19.
- Niraj G, Kelkar A, Jeyapalan I, Graff-Baker P, Williams O, Darbar A, Maheshwaran A, Powell R. Comparison of analgesic efficacy of subcostal transversus abdominis plane blocks with epidural analgesia following upper abdominal surgery. Anaesthesia. 2011 Jun;66(6):465-71. doi: 10.1111/j.1365-2044.2011.06700.x. Epub 2011 Apr 4.
- Torup H, Mitchell AU, Breindahl T, Hansen EG, Rosenberg J, Moller AM. Potentially toxic concentrations in blood of total ropivacaine after bilateral transversus abdominis plane blocks; a pharmacokinetic study. Eur J Anaesthesiol. 2012 May;29(5):235-8. doi: 10.1097/EJA.0b013e328350b0d5.
- Conaghan P, Maxwell-Armstrong C, Bedforth N, Gornall C, Baxendale B, Hong LL, Carty HM, Acheson AG. Efficacy of transversus abdominis plane blocks in laparoscopic colorectal resections. Surg Endosc. 2010 Oct;24(10):2480-4. doi: 10.1007/s00464-010-0989-y. Epub 2010 Apr 8.
- Hilton AK, Pellegrino VA, Scheinkestel CD. Avoiding common problems associated with intravenous fluid therapy. Med J Aust. 2008 Nov 3;189(9):509-13. doi: 10.5694/j.1326-5377.2008.tb02147.x.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Tumeurs par site
- Tumeurs
- Tumeurs abdominales
- Effets physiologiques des médicaments
- Dépresseurs du système nerveux central
- Agents du système nerveux périphérique
- Analgésiques
- Agents du système sensoriel
- Anesthésiques intraveineux
- Anesthésiques, général
- Anesthésiques
- Analgésiques, Opioïdes
- Stupéfiants
- Adjuvants, Anesthésie
- Anesthésiques locaux
- Fentanyl
- Bupivacaïne
Autres numéros d'identification d'étude
- 2013-218
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