Fentanyl Versus Tramadol as Co-administrator to Bupivacaine
12. december 2020 opdateret af: huda fahmy, Aswan University Hospital
Fentanyl Versus Tramadol as Co-administrator to Bupivacaine in Ultrasound-guided Supraclavicular Brachial Plexus Blockade: Pons and Cons
Supraclavicular brachial plexus approach is an alternative technique to general anesthesia resulting in a fast onset of a reliable blockage of the brachial plexus.
The use of ultrasound for the performance of supraclavicular block has become the gold standard since it enables the clinician to deposit the local anesthetic close to the nerves in real-time that improves the success rate with a safety margin.
Adjuvants are added to local anesthetic in Supraclavicular Brachial Plexus Blockade to improve the quality of nerve blocks and the duration of analgesia.
It should be noted that no adjuvant has been approved by the Food and Drug Administration (FDA) for the prolongation of peripheral nerve blocks
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
There are multiple controversies among the previous studies for the use of different opioids as adjuvants for brachial plexus blockade to improve various block characteristics. Moreover, limited studies estimate the pons and cons of tramadol versus fentanyl as co-administrator to bupivacaine in Ultrasound-guided Supraclavicular Brachial Plexus Blockade.
In our study, we aim to assess the utility of fentanyl versus tramadol as co-administrator to bupivacaine in ultrasound-guided supraclavicular brachial plexus blockade in upper limb surgeries in a prospective randomized controlled fashion. The primary outcome is to compare between the efficacy of tramadol versus fentanyl as adjuvants on the onset and duration of sensory and motor block and the secondary outcome is to compare between the efficacy of tramadol versus fentanyl as adjuvants on postoperative analgesia, time of the request to rescue analgesia, postoperative analgesic consumption, and complications.
The patients were aged between 18 and 60, both gender, and the American Society of Anesthesiologists (ASA) physical status I/II. However, patients who had bleeding disorders got opioid analgesics or monoamine oxidase inhibitors before surgery, had a history of seizures, respiratory or cardiac diseases, local infections at the site where needle for the block is to be inserted, pregnant woman and in whom the block effect was partial and required supplementary anesthesia were excluded from the study.
Patients were randomly allocated into three groups for ultrasound-guided supraclavicular brachial plexus block. Randomization was established using the computer-generated closed envelopes method.
Group B (bupivacaine group): patients received 20 ml bupivacaine 0.5% plus 2 ml normal saline Group F (fentanyl group): patients received 20 ml bupivacaine 0.5% plus fentanyl (1µg/kg-2 ml) Group T (tramadol group): patients received 20 ml bupivacaine 0.5% plus tramadol (1mg/kg-2 ml)
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
66
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Aswan, Egypten, 81511
- Aswan University Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I/II. scheduled for forearm or hand surgery
Exclusion Criteria:
- bleeding disorders
- patients who got opioid analgesics or monoamine oxidase inhibitors before surgery,
- history of seizures, respiratory or cardiac diseases
- local infections at the site where the needle for the block is to be inserted
- a pregnant woman
- the block effect was partial and required supplementary anesthesia
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Group B (bupivacaine group)
patients received 20 ml bupivacaine 0.5% plus normal saline (2ml)
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Ultrasound-guided supraclavicular brachial plexus block was done using an ultrasound machine (Philips; Model: OTD020, AcBel Polytech Inc., Taiwan) with a 5-10 MHz linear probe.
The brachial plexus and its relation to the surrounding structures were viewed while the patient was supine and the head turned 45° to the contralateral side.
In the supraclavicular fossa, the probe was placed in the coronal plane to visualize the subclavian artery and the brachial plexus in a transverse sectional view.
After skin sterilization and local anesthetic administration, an insulated needle was then introduced lateral to the ultrasound probe and parallel to the long axis of the probe.
Once the needle penetrated the brachial plexus cluster, the local anesthetic mixture was injected incrementally after negative aspiration for blood or air just next to the artery, then the needle was repositioned to inject on the upper pole of the artery.
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Aktiv komparator: Group F (fentanyl group)
patients received 20 ml bupivacaine 0.5% plus fentanyl (100µg-2 ml)
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Ultrasound-guided supraclavicular brachial plexus block was done using an ultrasound machine (Philips; Model: OTD020, AcBel Polytech Inc., Taiwan) with a 5-10 MHz linear probe.
The brachial plexus and its relation to the surrounding structures were viewed while the patient was supine and the head turned 45° to the contralateral side.
In the supraclavicular fossa, the probe was placed in the coronal plane to visualize the subclavian artery and the brachial plexus in a transverse sectional view.
After skin sterilization and local anesthetic administration, an insulated needle was then introduced lateral to the ultrasound probe and parallel to the long axis of the probe.
Once the needle penetrated the brachial plexus cluster, the local anesthetic mixture was injected incrementally after negative aspiration for blood or air just next to the artery, then the needle was repositioned to inject on the upper pole of the artery.
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Aktiv komparator: Group T (tramadol group)
patients received 20 ml bupivacaine 0.5% plus tramadol (100mg-2 ml)
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Ultrasound-guided supraclavicular brachial plexus block was done using an ultrasound machine (Philips; Model: OTD020, AcBel Polytech Inc., Taiwan) with a 5-10 MHz linear probe.
The brachial plexus and its relation to the surrounding structures were viewed while the patient was supine and the head turned 45° to the contralateral side.
In the supraclavicular fossa, the probe was placed in the coronal plane to visualize the subclavian artery and the brachial plexus in a transverse sectional view.
After skin sterilization and local anesthetic administration, an insulated needle was then introduced lateral to the ultrasound probe and parallel to the long axis of the probe.
Once the needle penetrated the brachial plexus cluster, the local anesthetic mixture was injected incrementally after negative aspiration for blood or air just next to the artery, then the needle was repositioned to inject on the upper pole of the artery.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Varighed af sensorisk blokering i timer
Tidsramme: 24 timer
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Det er tiden fra sensorisk blokering begynder til tidspunktet for genoprettelse af følelsen på operationsstedet
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24 timer
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Varighed af motorblokering i timer
Tidsramme: 24 timer
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Det er tiden fra motorisk blokering begynder til genoprettelsen af global mobilitet i hånden og håndleddet.
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24 timer
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Onset time of sensory block in minutes
Tidsramme: 40 minutes
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After the injection of the solution, every patient was checked for the onset of sensory blockade using goose soaked with iced normal saline by the following scale (three-point scale): Grade 0= perceived as normal sensation, Grade 1 = loss of cold sensation (analgesia), Grade 2= loss of sensation of touch (anesthesia).
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40 minutes
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onset time of motor blockade in minutes using the modified Bromage scale (Three-point scale)
Tidsramme: 40 minutes
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the modified Bromage scale (Three-point scale): Grade 0: Normal motor function, Grade 1: Decreased motor strength with the ability to move the fingers only, Grade 2: Complete motor block with an inability to move the fingers.
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40 minutes
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperativ første analgetikaanmodningstid i timer
Tidsramme: 24 timer
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blev taget fra tidspunktet for fuldstændig sensorisk blokering til anmodningen om at redde analgesi, når VAS > 4 cm.
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24 timer
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Gennemsnitligt blodtryk i mmHg
Tidsramme: 24 timer
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blev målt før blokeringen (0 min) og 5, 10, 15, 30 minutter derefter 1, 2, 3, 6, 12, 18 og 24 timer efter blokeringen
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24 timer
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puls i slag/minut
Tidsramme: 24 timer
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blev målt før blokeringen (0 min) og 5, 10, 15, 30 minutter derefter 1, 2, 3, 6, 12, 18 og 24 timer efter blokeringen.
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24 timer
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perifer iltmætning
Tidsramme: 24 timer
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blev målt før blokeringen (0 min) og 5, 10, 15, 30 minutter derefter 1, 2, 3, 6, 12, 18 og 24 timer efter blokeringen.
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24 timer
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Visual analog scale (VAS): the VAS consisted of a straight, vertical 10-cm line; the bottom point represented "no pain" = (0 cm) and the top "the worst pain you ever have" = (10 cm).
Tidsramme: 24 hours
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Patients were asked to rate their pain intensity at 1, 2, 4, 6, 12, 18, and 24 h after the block
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24 hours
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Rescue analgesia in the form of 0.05 mg/kg morphine sulfate intravenously
Tidsramme: 24 hours
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was given when VAS ≥ 4 cm
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24 hours
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: huda fahmy, ph D, Aswan University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. februar 2019
Primær færdiggørelse (Faktiske)
31. august 2020
Studieafslutning (Faktiske)
30. september 2020
Datoer for studieregistrering
Først indsendt
1. december 2020
Først indsendt, der opfyldte QC-kriterier
7. december 2020
Først opslået (Faktiske)
14. december 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. december 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. december 2020
Sidst verificeret
1. december 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 337/2/19
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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