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This study will be conducted to evaluate the effect of different temperature on the spinal anesthesia characteristics and incidence of complications
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| levobupivacaine at ( 23˚C) | Placebo Comparator | Levobupivacine hydrochloride at ( 23˚C) will be received 3.5 ml levobupivacaine at the operating room temperature 23˚C will be administered |
|
| Warm levobupivacaine at (30˚C) | Active Comparator | 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 |
|
| Warm levobupivacaine at (37˚C) | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivacaine | 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adham Elgeidi | Contact | 01061057973 | elgeidi@doctors.org.uk | |
| Medhat Messeha | Contact | 01207788199 | medhatmikha70@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Reem El sharkawy | lecturer of anesthesia and surgical intensive care ,faculty of medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adham Elgeidi | Al Mansurah | Dakahliah | 35516 | Egypt |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Double(participant ,care provider)
|
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 |
| Aniline Compounds |
| D000588 | Amines |