The Effect of Different Degree of Temperature on Levobupivacaine Spinal Anesthesia

Spinal Anesthetic Toxicity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03790163
• Other study ID #: MFM.IRB,R/18.11.340
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: April 2019

Study information

• Verified date: December 2018
• Source: Mansoura University Hospital
• Contact: Adham Elgeidi
• Phone: 01061057973
• Email: elgeidi[@]doctors.org.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Anesthetic Toxicity

Intervention

Drug:
• Levobupivacaine
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)

Locations

Country	Name	City	State
Egypt	Adham Elgeidi	Mansourah	Dakahliah

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to onset of sensory block	Defined as the time interval between the end of spinal anesthesia injection and the loss of sensation to pin prick (sensory score=1)	For 10 minutes following the spinal anesthesia
Secondary	Time to the onset of motor block	Defined as the time interval between the end of spinal anesthesia and (motor score=1) within both lower limbs	For 10 minutes following the injection of spinal anesthesia
Secondary	Duration of sensory block	Defined as the interval between the end of spinal anesthesia and complete end of sensory block (sensory score=2)	For 24 hours after the spinal anesthesia
Secondary	Duration of motor block	Defined as the interval between the end of spinal anesthesia and complete recovery of normal motor function (score=0)	For 24 hours after the spinal anesthesia
Secondary	Post spinal shivering	Post 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 )	for 24 hours after spinal anesthesia