Dosage of Intrathecal Hyperbaric Bupivacaine and the Incidence of Post Spinal Shivering.

Study Overview
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Brief Summary
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Shivering is very common after spinal anaesthesia. Many studies have investigated the role of adding adjuvants to the local anaesthetics to decrease the incidence of post-spinal shivering. Non of the studies n the literature review have investigated the role of different dose of local anaesthetic alone in reducing the incidence of post-spinal shivering. In the present study the investigators aimed to compare the effect of different local anaesthetic dose in reducing post-spinal shivering.

Detailed Description
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After approval of the ethics committee, department of anaesthesia, Menoufia University and written informed consent, a hundred full-term pregnant ladies undergoing elective cesarean section were enrolled in this study. The pregnant ladies were randomly assigned using a computerised software to one of two groups, low dose bupivacaine (LB) and high dose bupivacaine (HB), 50 patients each according to bupivacaine dose. Group LB received low dose bupivacaine (8 mg hyperbaric bupivacaine) Group HB received high dose bupivacaine (10 mg hyperbaric bupivacaine). Vital signs including heart rate and mean arterial blood pressure intra-operatively until the end of surgery. The severity of shivering was the primary endpoint. Shivering was graded using a scale: 0, no shivering; 1, piloerection but no visible muscle activity; 2, muscular activity in one group of muscle; 3, muscular activity in more than one muscle group but not generalized movement; and 4, shivering involving the movement of the whole body. Shivering score was recorded for the whole study period.

Official Title
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Dosage of Intrathecal Hyperbaric Bupivacaine and the Incidence of Post Spinal Shivering in Cesarean Section: is There a Relation?

Conditions
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Cesarean Section; Shivering

Intervention / Treatment
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* Drug: Low dose bupivacaine 0.5% (8mg)
* Drug: High dose bupivacaine 0.5% (10mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged between 22 and 35 year old, and American Society of Anesthetists (ASA) I or II were included in the study and consented to have spinal anaesthesia for their section. Exclusion Criteria: Patients who had contraindication to spinal anesthesia, high-risk pregnancy, history of seizures, mental illness, acute fetal distress, and patients refused spinal anesthesia were excluded from the study.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 35 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

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low dose bupivacaine 0.5% (8mg)<br>Bupivacaine 0.5% for spinal anesthesia | Drug: Low dose bupivacaine 0.5% (8mg)<br>* 8 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.1 ml<br>* Other names: Bupivacaine for spinal anaesthesia.;|
| Active Comparator: High dose bupivacaine 0.5% (10mg)<br>Bupivacaine 0.5% for spinal anesthesia | Drug: High dose bupivacaine 0.5% (10mg)<br>* 10 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.5<br>* Other names: Bupivacaine for spinal anaesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shivering score | Shivering score is a graded score using a scale: 0, no shivering; 1, piloerection but no visible muscle activity; 2, muscular activity in one group of muscle; 3, muscular activity in more than one muscle group but not generalised movement; and 4, shivering involving the movement of the whole body. | Peri-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial blood pressure (mmHg) | Mean arterial blood pressure reading | Peri-operatively | 
| Heart rate (beat/minute) | The number of hear beats per minute | Peri-operatively |