Clinical trial NCT03265886: The Influence of Warm Bupivacaine on Supraclavicular Plexus Block Characteristics
Official title: The Influence of Bupivacaine Temperature on Supraclavicular Plexus Block Characteristics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery to the Distal One Third of the Upper Limb
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Time to onset of sensory block
timeFrame: for 30 min following injection
Secondary outcomes:
measure: Time to onset of motor block
timeFrame: For 3 hours after the injection of local anesthetic
measure: Heart rate
timeFrame: For 3 hours after the injection of local anesthetic
measure: Blood pressure
timeFrame: For 3 hours after the injection of local anesthetic
measure: oxygen saturation in the peripheral blood
timeFrame: For 3 hours after the injection of local anesthetic
measure: Duration of sensory block
timeFrame: For 24 hours after the injection of local anesthetic
measure: Duration of motor block
timeFrame: For 24 hours after the injection of local anesthetic
measure: The severity of postoperative pain
timeFrame: For 24 hours after the injection of local anesthetic
measure: Time for first analgesic request
timeFrame: For 24 hours after the injection of local anesthetic
measure: Total analgesics received
timeFrame: for 24 hrs after the injection of local anesthetic
measure: Satisfaction Score
timeFrame: for 48 hrs after the injection of local anesthetic
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University, Faculty of Medicine
state: DK
Study officials:
affiliation: Professor of Anesthesia and Surgical Intensive Care
name: Mohamed Y Makharita, MD
role: STUDY_CHAIR
References: