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- Klinische proef NCT05080985
Paravertebral Block Versus Erector Spinae Plane Block for Analgesia in Modified Radical Mastectomy
Paravertebral Block Versus Erector Spinae Plane Block for Analgesia and Opioid Consumption in Modified Radical Mastectomy; Randomized, Prospective, Double Blind
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
A total of 86 patients were randomized into TPVB (Group P) and ESPB (Group E) by using closed envelopes.
All patients in the operating room has same anesthetic management under standard monitoring modalities. Prior to regional technique, mild sedation was achieved with midazolam (1-2 mg) and fentanyl (50 mcg). Both blocks were performed under ultrasonography guidance from the level of T4 vertebra with a linear probe (5MHz; GE Healthcare, Wauwatosa, Wis, USA) using longitudinally out-of-plane technique by an anesthesiologist. A 22-gauge, 50 mm insulated stimulating needle was used.By using reference points of C7 and T7, spinous processes of thoracic vertebras were marked. 10% povidone iodine was used for skin antisepsis. USG probe was longitudinally placed at the level of T4. Staff anesthesiologist had to visualize of adjacent muscles, transverse process (TP) and pleura.
For ESPB; confirmation of the needle position was achieved with spread of 2 ml saline between the deep fascia of the erector spinae muscle and the TP. After negative aspiration 20 ml 0.375% bupivacaine was injected with appropriate distribution of LA.
For TPVB; the needle was advanced passing over superior costotransverse ligament and target space was confirmed by the downward displacement of pleura after the administration of 2 ml 0.9% NaCl. After negative aspiration, 20 ml 0.375 % bupivacaine was injected with appropriate distribution of local anesthetics.
Vascular puncture, haematoma, neuraxial injury and pneumothorax were defined as block complications and should be noted.
30 minutes after the block achieved, pinprick test was performed on both mid-axillary and midclavicular lines from T1 to T12 (0 there is sensation, 1 decreased sensation, 2 there is no sensation).
Anesthesia induction was unique for all patients with 0.03 mg kg-1 midazolam, 0.5 mcg kg-1 fentanyl, 2 mg kg-1 propofol and 0.6 mg kg-1 rocuronium. Maintenance was achieved with sevoflurane of 1 minimum alveolar concentration in a mixture of 40% O2 and 60% N2O. As a component of multimodal analgesia, paracetamol (1 gr) was applied to all patients before skin incision.
Hemodynamic data were recorded throughout surgery. An increase more than 20% from baseline in mean arterial pressure (MAP) was defined as inadequate analgesia and was treated with bolus fentanyl (50 mcg). Hypotension was described with a decrease more than 20% in MAP and treated with ephedrine bolus. Bradycardia was determined with a heart rate (HR) less than 50 beats min-1 and treated with atropine. At the end of surgery, the patients were extubated in operating room.
Postoperative analgesia was achieved with IV morphine via Patient Controlled Analgesia (PCA) for 24 hours (0.01 mg kg-1 h-1 basal infusion, 1 mg bolus, 20 minutes lock-out time).
Postoperative follow-up included hemodynamic variables as well as pain scores and morphine consumption. Adequate analgesia at rest (static) and at moving of the arm interpreted as 45-90 degree abduction (dynamic) was investigated with Numeric Rating Scale (NRS) at 30th minute and 1st, 4th, 6th, 12th, 24th hours postoperatively. When NRS was 4 and higher, tramadol should be administered as rescue analgesic. In case of insufficient pain control at 30th minute, dermatomal analgesia should be assessed for both mid-axillary and midclavicular lines from T1 to T8 by pinprick test (0 there is sensation, 1 decreased sensation, 2 there is no sensation). Morphine consumption was evaluated at same study times.
Complications were determined as sedation assessed by Ramsey scale, postoperative nausea- vomiting (PONV) assessed with the four-point categorical scale (0=no PONV, 1=mild nausea, 2=severe nausea or vomiting once, and 3=vomiting more than once). Severe vomiting should be treated in a multimodal way and excluded from the study (category 2,3).
Staff anesthesiologist responsible for operative course did not contribute in analgesia assessment, nor in other postoperative follow-up. Other investigators who were blinded to operative management, collected postoperative data.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Istanbul, Kalkoen, 34093
- Istanbul University, Istanbul Faculty of Medicine
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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:
- unilateral MRM
- ages 18-75 years
- American Society of Anesthesiologists (ASA) classification I-III
Exclusion Criteria:
- presence of contraindications for using regional anesthesia (not having patient approval, presence of bleeding-clotting disorders, infection at the injection site, local anesthetic allergy)
- chronic analgesic use
- diabetes mellitus
- body mass index of (BMI) > 35 kg/m2.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Group P : TPVB
Thoracic paravertebral block
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20 ml 0.375 % bupivacaine was injected between superior costotransverse ligament and pleura.
20 ml 0.375 % bupivacaine was injected
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Experimenteel: Group E : ESPB
Erector spinae plane block
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20 ml 0.375 % bupivacaine was injected
20 ml 0.375 % bupivacaine was injected between deep fascia of the erector spinae muscle and transverse process.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Morphine consumption
Tijdsspanne: postoperative 24 hours
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amount of postoperative 24 hours morphine consumption
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postoperative 24 hours
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Static and dynamic pain score assessed with Numeric Rating Scale (NRS).
Tijdsspanne: postoperative 24 hours
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Pain scores will be noted postoperative at 0, 30 minutes and 1,4,6,12,24 hours.
NRS=0 (minimum value, no pain).
NRS=10 (maximum value, worst pain imaginable).
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postoperative 24 hours
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intraoperative heart rate
Tijdsspanne: during surgery
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starting from induction to extubation (beat/min)
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during surgery
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intraoperative mean arterial pressure
Tijdsspanne: during surgery
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starting from induction to extubation (mmHg)
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during surgery
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nause and vomit
Tijdsspanne: postoperative 24 hours
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Assessed with Postoperative Nause and Vomit (PONV) Scale.
(0=no PONV, 1=mild nausea, 2=severe nausea or vomiting once, and 3=vomiting more than once)
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postoperative 24 hours
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number of blocked dermatome
Tijdsspanne: 30 minutes after block
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pinprick test in mid-axillar and mid-clavicular line
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30 minutes after block
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Nükhet Sivrikoz, Attending anesthesiologist
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2018-1608
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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Klinische onderzoeken op TPVB
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Ankara City Hospital BilkentWervingAcute pijn | Thoracotomie | Postoperatieve analgesie | Plaatselijke verdoving | Thoracaal paravertebraal blokKalkoen
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Kunming Medical UniversityVoltooid
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Koç UniversityVoltooidPostoperatieve pijnKalkoen
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Seoul National UniversitySMG-SNU Boramae Medical CenterVoltooidComplexe regionale pijnsyndromen | Neuropatische pijn | Fantoompijn in ledematen | Postherpetische neuralgie | Posttraumatische neuralgie | Chronische postoperatieve pijnKorea, republiek van
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Kafrelsheikh UniversityVoltooidAnalgesie | Erector Spinae vliegtuigblok | Quadratus Lumborum-blok | Paravertebraal blokEgypte
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Assiut UniversityNog niet aan het wervenChronische pijn | Borstamputatie; Lymfoedeem | Paravertebraal blok | BorstzenuwblokkadeEgypte
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Cui XuleiBeëindigdZenuwblokkade, nefrectomie, analgesieChina
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Amal Gouda Elsayed SafanMohamed Emad Basune; Wesam Eldin Sultan; Rabab Mohammed HabeebVoltooidPostoperatieve pijnEgypte
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West China HospitalVoltooidAnalgesie | Zenuw blok | Pectus ExcavatumChina