The Influence of Warm Bupivacaine on Supraclavicular Plexus Block Characteristics

Study Overview
=================
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.

Official Title
-----------------
The Influence of Bupivacaine Temperature on Supraclavicular Plexus Block Characteristics

Conditions
-----------------
Surgery to the Distal One Third of the Upper Limb

Intervention / Treatment
-----------------
* Drug: Warm bupivacaine at (37°c)
* Drug: Bupivacaine at operating room temperature (23°c)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Warm bupivacaine at (37°c)<br>Warmed bupivacaine at body temperature will be administered | Drug: Warm bupivacaine at (37°c)<br>* 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.<br>|
| Active Comparator: Bupivacaine at operating room temperature (23°c)<br>Bupivacaine at temperature of 23°C will be administered | Drug: Bupivacaine at operating room temperature (23°c)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to onset of sensory block | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to onset of motor block | 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 |  | 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 | 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 | 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 | 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 | 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 | Cumulative use of rescue analgesics after performing the blockade | for 24 hrs after the injection of local anesthetic | 
| Satisfaction Score | Using score including 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor | for 48 hrs after the injection of local anesthetic |