- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03265886
The Influence of Warm Bupivacaine on Supraclavicular Plexus Block Characteristics
The Influence of Bupivacaine Temperature on Supraclavicular Plexus Block Characteristics
Despite PH adjustment of local anesthetic solution improves the quality of the block in all respects with special advantage of early onset of sensory and motor block, adequate level of analgesia, and prolongation of duration of block, the effect of warmed bupivacaine should have the same effect which have not been evaluated on supraclavicular plexus block for upper limb surgery.
The warmed bupivacaine used in supraclavicular plexus block may reduce sensory and motor block onset and prolong the duration of analgesia when compared to bupivacaine at operating room temperature.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
DK
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Mansourah, DK, Egypten, 050
- mansoura university, faculty of medicine
-
-
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 physical class I or II
Exclusion Criteria:
- Patient refusal.
- Pregnancy
- Neuromuscular diseases (as myopathies, myasthenia gravies…)
- Hematological diseases
- Bleeding disorders
- Coagulation abnormality.
- Psychiatric diseases.
- Local skin infection
- Sepsis at site of the block.
- Known intolerance to the study drugs.
- Body Mass Index > 40 Kg/m2.
- Bilateral upper limb injury to be performed at the same procedure.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Warm bupivacaine at (37°c)
Warmed bupivacaine at body temperature will be administered
|
Bupivacaine 0.5%, 30 mL, warmed to 37◦C for 20 minutes.
The empty syringes and needles, in their packaging, will be held at the same temperature before initiating the block.
|
Aktiv komparator: Bupivacaine at operating room temperature (23°c)
Bupivacaine at temperature of 23°C will be administered
|
Bupivacaine 0.5%, 30 ml held in crash shelf of the operating room temperature at 23◦C.
The empty syringes and needles will be held in the same temperature before use.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Time to onset of sensory block
Tidsram: for 30 min following injection
|
defined as the time interval between the end of local anesthetic injection and the loss of sensation to pinprick (sensory score = 1)
|
for 30 min following injection
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Time to onset of motor block
Tidsram: For 3 hours after the injection of local anesthetic
|
defined as time interval between the end of local anesthetic injection and (motor score = 1) in the distributions of all 4 peripheral nerves.
|
For 3 hours after the injection of local anesthetic
|
Heart rate
Tidsram: For 3 hours after the injection of local anesthetic
|
For 3 hours after the injection of local anesthetic
|
|
Blood pressure
Tidsram: For 3 hours after the injection of local anesthetic
|
For 3 hours after the injection of local anesthetic
|
|
oxygen saturation in the peripheral blood
Tidsram: For 3 hours after the injection of local anesthetic
|
For 3 hours after the injection of local anesthetic
|
|
Duration of sensory block
Tidsram: For 24 hours after the injection of local anesthetic
|
defined as the interval between end of injection and complete end of sensory block (score=2)
|
For 24 hours after the injection of local anesthetic
|
Duration of motor block
Tidsram: For 24 hours after the injection of local anesthetic
|
defined as the interval between end of injection and complete recovery of normal motor function (score=0), respectively.
|
For 24 hours after the injection of local anesthetic
|
The severity of postoperative pain
Tidsram: For 24 hours after the injection of local anesthetic
|
will be measured and recorded by using a 100-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 100 indicates the worst possible pain.
|
For 24 hours after the injection of local anesthetic
|
Time for first analgesic request
Tidsram: For 24 hours after the injection of local anesthetic
|
Time to the first receiving of rescue analgesic from the time of blockade
|
For 24 hours after the injection of local anesthetic
|
Total analgesics received
Tidsram: for 24 hrs after the injection of local anesthetic
|
Cumulative use of rescue analgesics after performing the blockade
|
for 24 hrs after the injection of local anesthetic
|
Satisfaction Score
Tidsram: for 48 hrs after the injection of local anesthetic
|
Using score including 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor
|
for 48 hrs after the injection of local anesthetic
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Mohamed Y Makharita, MD, Professor of Anesthesia and Surgical Intensive Care
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
- MFM-IRB, MS/17.05.143
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
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