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The Effect of Different Degree of Temperature on Levobupivacaine Spinal Anesthesia

The Influence of Different Degrees of Levobupivacaine Temperature on Spinal Anesthesia in Orthopedic Surgeries: Prospective Randomized Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03790163
Enrollment
120
Registered
2018-12-31
Start date
2019-01-15
Completion date
2019-04-30
Last updated
2019-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Anesthetic Toxicity

Keywords

levobupivacaine,spinal anesthesia ,temperature

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

Interventions

DRUGLevobupivacaine

Drug: levobupivacaine at room temperature ( 23˚C) and second group levobupivacaine warmed to the (30˚C) while the third group levobupivacaine warmed to the body temperature (37˚C)

Sponsors

Mansoura University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Masking description

Double(participant ,care provider)

Eligibility

Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to onset of sensory blockFor 10 minutes following the spinal anesthesiaDefined as the time interval between the end of spinal anesthesia injection and the loss of sensation to pin prick (sensory score=1)

Secondary

MeasureTime frameDescription
Time to the onset of motor blockFor 10 minutes following the injection of spinal anesthesiaDefined as the time interval between the end of spinal anesthesia and (motor score=1) within both lower limbs
Duration of sensory blockFor 24 hours after the spinal anesthesiaDefined as the interval between the end of spinal anesthesia and complete end of sensory block (sensory score=2)
Duration of motor blockFor 24 hours after the spinal anesthesiaDefined as the interval between the end of spinal anesthesia and complete recovery of normal motor function (score=0)
Post spinal shiveringfor 24 hours after spinal anesthesiaPost spinal shivering will be graded using a scale ( score 0=no shivering ,score 1= no visible muscle activity ,but one or more of piloerection, score 2=muscular activity in only one muscle group,score 3=moderate muscular activity in more than one muscle group but not generalized shaking ,score 4=violent muscular activity that involves entire body )

Countries

Egypt

Contacts

Primary ContactAdham Elgeidi
elgeidi@doctors.org.uk01061057973
Backup ContactMedhat Messeha
medhatmikha70@yahoo.com01207788199

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026