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

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

Study Overview

• Status: Unknown
• Conditions: Spinal Anesthetic Toxicity
• Intervention / Treatment: Drug: Levobupivacaine

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

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahliah
    • Mansourah, Dakahliah, Egypt, 35516
      • Adham Elgeidi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: levobupivacaine at ( 23˚C); Levobupivacine hydrochloride at ( 23˚C) will be received 3.5 ml levobupivacaine at the operating room temperature 23˚C will be administered	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); Other Names: Chirocaine
Active Comparator: Warm levobupivacaine at (30˚C); Drug:Warm levobupivacaine hydrochlorid (3.5 ml) will be warmed at (30˚C) for 24 hours. The empty syringes and needles ,in their packaging, will be held at the same temperature before the spinal anesthesia	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); Other Names: Chirocaine
Active Comparator: Warm levobupivacaine at (37˚C); Drug:Warm levobupivacaine hydrochlorid (3.5 ml) will be warmed at (37˚C) for 24 hours. The empty syringes and needles ,in their packaging, will be held at the same temperature before the spinal anesthesia	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); Other Names: Chirocaine

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 spinal anesthesia injection and the loss of sensation to pin prick (sensory score=1)	For 10 minutes following the spinal anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Mansoura University Hospital
• Investigators: Principal Investigator: Reem El sharkawy, lecturer of anesthesia and surgical intensive care ,faculty of medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2019
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: December 24, 2018
• First Submitted That Met QC Criteria: December 27, 2018
• First Posted (Actual): December 31, 2018

Study Record Updates

• Last Update Posted (Actual): January 2, 2019
• Last Update Submitted That Met QC Criteria: December 28, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: levobupivacaine,spinal anesthesia ,temperature
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Levobupivacaine
• Other Study ID Numbers: MFM.IRB,R/18.11.340

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No