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Fentanyl Versus Tramadol as Co-administrator to Bupivacaine
Fentanyl Versus Tramadol as Co-administrator to Bupivacaine in Ultrasound-guided Supraclavicular Brachial Plexus Blockade: Pons and Cons
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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)
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Aswan, Egypte, 81511
- Aswan University Hospital
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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:
- 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
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: 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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Actieve vergelijker: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Duur van sensorische blokkade in uren
Tijdsspanne: 24 uur
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Het is de tijd vanaf het begin van de sensorische blokkade tot het moment van herstel van het gevoel op de plaats van de operatie
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24 uur
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Duur motorblok in uren
Tijdsspanne: 24 uur
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Het is de tijd vanaf het begin van de motorische blokkade tot het herstel van de globale mobiliteit in de hand en de pols.
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24 uur
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Onset time of sensory block in minutes
Tijdsspanne: 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)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Postoperatieve eerste analgetische aanvraagtijd in uren
Tijdsspanne: 24 uur
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werd genomen vanaf het moment van volledige sensorische blokkade tot het verzoek om analgesie te redden wanneer VAS > 4 cm.
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24 uur
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Gemiddelde bloeddruk in mmHg
Tijdsspanne: 24 uur
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werd gemeten voor het blok (0 min) en om 5, 10, 15, 30 min daarna 1, 2, 3, 6, 12,18 en 24 uur na het blok
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24 uur
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hartslag in slagen/minuut
Tijdsspanne: 24 uur
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werd gemeten voor de blokkade (0 min) en om 5, 10, 15, 30 min en daarna 1, 2, 3, 6, 12,18 en 24 uur na de blokkade.
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24 uur
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perifere zuurstofverzadiging
Tijdsspanne: 24 uur
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werd gemeten voor de blokkade (0 min) en om 5, 10, 15, 30 min en daarna 1, 2, 3, 6, 12,18 en 24 uur na de blokkade.
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24 uur
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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).
Tijdsspanne: 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
Tijdsspanne: 24 hours
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was given when VAS ≥ 4 cm
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24 hours
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: huda fahmy, ph D, Aswan University
Studie record data
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Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 337/2/19
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Klinische onderzoeken op ultrasound-guided supraclavicular brachial plexus blockade
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Bozyaka Training and Research HospitalVoltooidComplicaties | Brachiaal Plexus Blok | Ademhalingscomplicatie | Zenuw blok | Verlamming van de nervus phrenicus | Diafragma Sellae meningeoomKalkoen