Surgery to the Distal One Third of the Upper Limb
Conditions
Brief summary
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.
Detailed description
The aim of this study is to compare the effect of warm bupivacaine 0.5% at 37◦C versus bupivacaine 0.5% at operating room temperature at 23◦C on ultrasound-guided supraclavicular plexus block characteristics as regard sensory block onset time, motor block onset time, duration of sensory and motor block , effective duration of analgesia, total analgesics requirement, complications and side effects.
Interventions
DRUGWarm bupivacaine at (37°c)
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.
DRUGBupivacaine at operating room temperature (23°c)
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.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
Double-blind design
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to onset of sensory block | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | For 3 hours after the injection of local anesthetic | — |
| Blood pressure | For 3 hours after the injection of local anesthetic | — |
| oxygen saturation in the peripheral blood | For 3 hours after the injection of local anesthetic | — |
| Duration of sensory block | 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) |
| Time to onset of motor block | 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. |
| The severity of postoperative pain | 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. |
| Time for first analgesic request | For 24 hours after the injection of local anesthetic | Time to the first receiving of rescue analgesic from the time of blockade |
| Total analgesics received | for 24 hrs after the injection of local anesthetic | Cumulative use of rescue analgesics after performing the blockade |
| Satisfaction Score | for 48 hrs after the injection of local anesthetic | Using score including 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor |
| Duration of motor block | 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. |
Countries
Egypt
Outcome results
None listed