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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-30

Study Completion Date

2018-09-29

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.

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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.

Conditions

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Cesarean Section; Shivering

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Low dose bupivacaine 0.5% (8mg)

Bupivacaine 0.5% for spinal anesthesia

Group Type ACTIVE_COMPARATOR

Low dose bupivacaine 0.5% (8mg)

Intervention Type DRUG

8 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.1 ml

High dose bupivacaine 0.5% (10mg)

Bupivacaine 0.5% for spinal anesthesia

Group Type ACTIVE_COMPARATOR

High dose bupivacaine 0.5% (10mg)

Intervention Type DRUG

10 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.5

Interventions

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Low dose bupivacaine 0.5% (8mg)

8 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.1 ml

Intervention Type DRUG

High dose bupivacaine 0.5% (10mg)

10 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.5

Intervention Type DRUG

Other Intervention Names

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Bupivacaine for spinal anaesthesia. Bupivacaine for spinal anaesthesia

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.

Minimum Eligible Age

22 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No