The Effect of Different Degree of Temperature on Levobupivacaine Spinal Anesthesia

NCT ID: NCT03790163

Last Updated: 2019-01-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2019-04-30

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

Conditions

Spinal Anesthetic Toxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

Levobupivacaine

Intervention Type: DRUG

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)

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

Group Type: ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type: DRUG

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)

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

Group Type: ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Other Intervention Names

Chirocaine

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Abdelraouf Elsharkawy

Lecturer of anesthesia and surgical intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reem El sharkawy

Role: PRINCIPAL_INVESTIGATOR

lecturer of anesthesia and surgical intensive care ,faculty of medicine

Locations

Adham Elgeidi

Al Mansurah, Dakahliah, Egypt

Countries

Egypt

Central Contacts

Adham Elgeidi

Role: CONTACT

elgeidi@doctors.org.uk

01061057973

Medhat Messeha

Role: CONTACT

medhatmikha70@yahoo.com

01207788199

Other Identifiers

MFM.IRB,R/18.11.340

Identifier Type: -

Identifier Source: org_study_id