Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution

Study Overview
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Brief Summary
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The authors would like to investigate the blocking characteristics, surgical quality and side effects of intrathecal levobupivacaine whether there are any differences between the hyperbaric and the isobaric formulation for gynaecologic surgeries which need higher block level than the urological surgeries.

Detailed Description
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The investigators study in the similar patients, give the same intervention except the baricity of levobupivacaine. The investigators record the level of sensory block and modified Bromage score for motor blockade.

Official Title
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Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution

Conditions
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Observation of Neuromuscular Block, Disease (or Disorder); Gynecological

Intervention / Treatment
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* Drug: isobaric levobupivacaine
* Drug: hyperbaric levobupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-III, aged 18-70 yr, scheduled for elective gynaecologic surgery, (total abdominal hysterectomy (TAH), TAH with uni-/bilateral salpingo-oophorectomy (SO), uni-/bilateral ovarian cystectomy, or myomectomy Exclusion Criteria: contraindications for spinal block, body mass index (BMI) more than 35 kg/m2 and height less than 150 cm

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: isobaric levobupivacaine<br>spinal isobaric levobupivacaine | Drug: isobaric levobupivacaine<br>* 0.42% either isobaric levobupivacaine 3 ml spinal injection once<br>* Other names: Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway;|
| Active Comparator: hyperbaric levobupivacaine<br>hyperbaric levobupivacaine | Drug: hyperbaric levobupivacaine<br>* 0.42% hyperbaric levobupivacaine 3 ml spinal injection once<br>* Other names: Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to T4-dermatome sensory blockade | to investigate specific blocking characteristics of intrathecal hyperbaric levobupivacaine compared with isobaric levobupivacaine for gynaecologic surgery | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects | to investigate side effects of intrathecal hyperbaric levobupivacaine compared with isobaric levobupivacaine for gynaecologic surgery | 1 to 4 hours intraoperation plus within 2 hours in the recovery room | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal incision, hyperbaric, isobaric, levobupivacaine, spinal anaesthesia