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- Klinische proef NCT04336046
Ultrasound Guided Bilateral Erector Spinae Block as Analgesia for Adolescent Idiopathic Scoliosis Correction
Studie Overzicht
Toestand
Gedetailleerde beschrijving
-Preoperative: Evaluation of patients will be carried out through proper history taking, clinical examination and routine laboratory investigation and patients will be trained to use the Numerical Rating Scale (NRS 0= no pain, 10= intolerable pain) used for evaluation of pain intensity.
The patient is allowed to fast for 8 hours for solids and 2h for clear fluid. Before the study, all patients will be interviewed and will be briefed on the wake-up test procedure. They will be informed that they will be asked to open their eyes, move their fingers (hold the anesthesiologist's hand), move their toes, and finally, to remember a given color.
-Intraoperative: On arrival to operating roome, a 20 G peripheral IV cannula will be inserted. Electrocardiogram (ECG), noninvasive mean arterial blood pressure (MAP) and peripheral oxygen saturation will be attached and baseline data will be monitored and documented. Sedation will be given intravenously in the form of midazolam 0.02 mg/kg and IV fliud according to calculation of deficit and maintaince calculation.
After preoxygenation, anesthesia with IV propofol 2 mg/ kg and fentanyl 2 µg/kg will be administered for analgesia and cisatracurium 0.5 mg/ kg will be given intravenously to facilitate endotracheal intubation.
Central venous catheter will be inserted and attached for monitoring of CVP. Also, enotropy will be connected on the patientꞌs forehead and maintained between 40-60.
40 patients will be equally divided to two equal groups (20 patients for each group) Group 1: will receive sham bilateral ultrasounded guided erector spinae block using 1 mg /kg normal saline in a total volume of 20 ml for each side after induction of anaesthesia in prone position after induction of anaesthesia in prone position.
Group 2: will receive real bilateral ultrasounded guided erector spinae block by bupivacaine at 1 mg /kg in a total volume of 20 ml for each side after induction of anaesthesia in prone position.
Maintaince of anaesthesia will be 50 : 50 % O2 to air and sevoflurane 2% and cisatracurium incremental every 30 min at dose of 0.1 mg/kg. I.V analgesia in form of incremental fentanyl 1 ug /kg when entropy increases more than 60 during surgery and 30 min before the wake-up test.
Wake up test: Before continuation of anesthesia, patients will be given a color to remember. After finishing the wake-up test, anesthesia will be induced using 3 mg/kg propofol and 0.1 mg/kg cisatracurium, whereas anesthesia will be maintained as described previously.
At the end of surgery, inhalational anesthetic agent will be turned off, residual neuromuscular block will be reversed with neostigmine 0.05 mg/kg and atropine 0.01 mg/kg then patients will be extubated and will be transferred to post anesthesia care unit (PACU).
Postoperative multimodal analgesia: will received paracetamol 10 mg/kg every 6 hours and intravenous diclofenac 1.5 mg/kg every 8 hours regularly.
All observations will be carried out by a single investigator, who is blinded to the study groups.
-In all groups, the following will be measured: -
- Demographic data.
- Total doses of postoperative morphine consumption.
- Time of the first dose of rescue analgesia (morphine at dose of 0.1 mg/kg).
- Number of patients received rescue analgesia.
- Numerical Rating Scale (NRS) for pain that ranged from (0 = no pain) to (10 = intolerable pain). If score is >3 will need analgesia in the form of morphine 0.1 mg/kg will be given till NRS decreases to ≤3. NRS will be assessed and recorded on arrival to the Recovery Unit, 2, 4, 8, 12, 18, 24 h after the operation, by an anesthesiologist, who is blinded to the study groups.
- Total doses intraoperative consumption of fentanyl.
- Wake-up profile: On the surgeons' request for the intraoperative wake-up test, administration of sevoflurane will be stopped. (the quality of wake-up, return of spontaneous breathing, ability to open eyes on command, and ability to move hands and feet) and postoperative amnesia. Patients will be asked repeatedly during the wake-up test, at least every 15 s, to open their eyes and to move their hands and feet. The time elapsed from the interruption of anesthesia to the start of spontaneous breathing (T1), from the return of spontaneous breathing to eye opening on command (T2), and from eye opening to movement of hands and feet (T3) will be recorded in seconds using a stopwatch. The quality of the wake-up test will be evaluated on a three-point rank scale (8).
- First time of postoperative mobilization.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Tanta, Egypte
- Werving
- tarek Abdel Lattif
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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:
- patients with idiopathic adolescent scoliosis undergoing surgical correction.
Exclusion Criteria:
- Bleeding disorders (coagulopathy).
- Mental dysfunction.
- History of allergy to local anesthetics.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Sham-vergelijker: control group
will receive sham bilateral ultrasounded guided erector spinae block using 1 mg /kg normal saline in a total volume of 20 ml for each side after induction of anaesthesia in prone position after induction of anaesthesia in prone position.
|
will receive sham bilateral ultrasounded guided erector spinae block using 1 mg /kg normal saline in a total volume of 20 ml for each side after induction of anaesthesia in prone position after induction of anaesthesia in prone position.
using 1 mg /kg normal saline
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Experimenteel: erector spinae block
will receive real bilateral ultrasounded guided erector spinae block by bupivacaine at 1 mg /kg in a total volume of 20 ml for each side after induction of anaesthesia in prone position
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bupivacaïne
will receive real bilateral ultrasounded guided erector spinae block by bupivacaine at 1 mg /kg in a total volume of 20 ml for each side after induction of anaesthesia in prone position
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
postoperative morphine consumption
Tijdsspanne: within 24 hours postoperative
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postoperative morphine consumption
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within 24 hours postoperative
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
intraoperatieve consumptie van fentanyl
Tijdsspanne: intraoperatief
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intraoperatieve consumptie van fentanyl
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intraoperatief
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time to first analgesic request
Tijdsspanne: within 24 hours postoperative
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time to first analgesic request
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within 24 hours postoperative
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
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
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- bilateral erector spinae block
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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Klinische onderzoeken op Bupivacaine
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