Clinical trial NCT03790163: The Effect of Different Degree of Temperature on Levobupivacaine Spinal Anesthesia
Official title: The Influence of Different Degrees of Levobupivacaine Temperature on Spinal Anesthesia in Orthopedic Surgeries: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Anesthetic Toxicity
Keywords: levobupivacaine,spinal anesthesia ,temperature
Lead sponsor: Mansoura University Hospital
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will be conducted to evaluate the effect of different temperature on the spinal anesthesia characteristics and incidence of complications

Detailed description: Regional anesthesia techniques are also superior to systemic opioids agents with regard the analgesic profile and adverse effects .Spinal anesthesia is the most commonly used technique due to its unmatchable reliability,simplicity and cost-effectiveness. It provides a fast and effective onset of sensory and motor block, excellent muscle relaxation and prolonged postoperative analgesia .

Bupivacaine is commonly used local anesthetics because of its long duration of action and combined motor and sensory blockade. However, it has many drawbacks .It has a high propensity to cause hypotension and bradycardia. There is also cardiac toxicity.Levobupivacaine is an attractive alternative to bupivacaine because of the lower affinity for cardiac sodium channels and reducing the risk of cardiac toxicity.Moreover ,the isobaric levobupivacaine had more stability in cerebrospinal fluid and thus lead to more predictable drug spread, decreasing the incidence of hypotension and bradycardia. But its main disadvantage is the delayed onset .

A number of strategies have been used to hasten the onset of local anesthesia .The addition of fentanyl mixtures of local anesthetics and alkalization of the local anesthetics all shorten the onset time of sensory block. Recently the warming of the anesthetic agents (namely, lidocaine and bupivacaine) to 37° C hastens the sensory block in various surgical settings .

Up till now there is no study suggestive of any appropriate degree of temperature as adjuvant .Hence the present study will be conducted to evaluate the effect of different temperature on spinal anesthesia characteristics and the incidence its complication

Eligibility criteria: Inclusion Criteria:

* ASA-I or II

Exclusion Criteria:

* patient refusal; Any known hypersensitivity or contraindication to levobupivacaine pregnancy bleeding disorders local skin infections. Sepsis at the site of injection Coagulation abnormality Psychiatric disorders

Primary outcomes:
measure: Time to onset of sensory block
timeFrame: For 10 minutes following the spinal anesthesia
Secondary outcomes:
measure: Time to the onset of motor block
timeFrame: For 10 minutes following the injection of spinal anesthesia
measure: Duration of sensory block
timeFrame: For 24 hours after the spinal anesthesia
measure: Duration of motor block
timeFrame: For 24 hours after the spinal anesthesia
measure: Post spinal shivering
timeFrame: for 24 hours after spinal anesthesia
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Adham Elgeidi
state: Dakahliah
Study officials:
affiliation: lecturer of anesthesia and surgical intensive care ,faculty of medicine
name: Reem El sharkawy
role: PRINCIPAL_INVESTIGATOR
References: