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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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)
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Aswan, Egypten, 81511
- Aswan university hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Group B (bupivacaine group)
patients received 20 ml bupivacaine 0.5% plus normal saline (2ml)
|
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.
|
|
Aktiv komparator: Group F (fentanyl group)
patients received 20 ml bupivacaine 0.5% plus fentanyl (100µg-2 ml)
|
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.
|
|
Aktiv komparator: Group T (tramadol group)
patients received 20 ml bupivacaine 0.5% plus tramadol (100mg-2 ml)
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Varaktighet av sensorisk blockering i timmar
Tidsram: 24 timmar
|
Det är tiden från sensorisk blockering till tidpunkten för återställande av känseln på operationsstället
|
24 timmar
|
|
Motorblockets varaktighet i timmar
Tidsram: 24 timmar
|
Det är tiden från motorblockering till återställandet av global rörlighet i handen och handleden.
|
24 timmar
|
|
Onset time of sensory block in minutes
Tidsram: 40 minutes
|
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).
|
40 minutes
|
|
onset time of motor blockade in minutes using the modified Bromage scale (Three-point scale)
Tidsram: 40 minutes
|
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.
|
40 minutes
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperativ första analgetikabegäran i timmar
Tidsram: 24 timmar
|
togs från tidpunkten för fullständig sensorisk blockering till begäran att rädda analgesi när VAS > 4 cm.
|
24 timmar
|
|
Genomsnittligt blodtryck i mmHg
Tidsram: 24 timmar
|
mättes före blocket (0 min) och vid 5, 10, 15, 30 minuter sedan 1, 2, 3, 6, 12, 18 och 24 timmar efter blocket
|
24 timmar
|
|
hjärtfrekvens i slag/minut
Tidsram: 24 timmar
|
mättes före blocket (0 min) och 5, 10, 15, 30 min sedan 1, 2, 3, 6, 12, 18 och 24 timmar efter blocket.
|
24 timmar
|
|
perifer syremättnad
Tidsram: 24 timmar
|
mättes före blocket (0 min) och 5, 10, 15, 30 min sedan 1, 2, 3, 6, 12, 18 och 24 timmar efter blocket.
|
24 timmar
|
|
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).
Tidsram: 24 hours
|
Patients were asked to rate their pain intensity at 1, 2, 4, 6, 12, 18, and 24 h after the block
|
24 hours
|
|
Rescue analgesia in the form of 0.05 mg/kg morphine sulfate intravenously
Tidsram: 24 hours
|
was given when VAS ≥ 4 cm
|
24 hours
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: huda fahmy, ph D, Aswan University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 337/2/19
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .