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Completed

NCT Number: NCT03356899

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

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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Key information

Age range

22 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Menoufia Univeristy

Shibīn al Kawm, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low dose bupivacaine 0.5% (8mg)

Drug

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

Other names: Bupivacaine for spinal anaesthesia.

High dose bupivacaine 0.5% (10mg)

Drug

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

Other names: Bupivacaine for spinal anaesthesia

Primary outcomes

  1. Shivering score

    Time frame: Peri-operatively

    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.

Secondary outcomes

  1. Mean arterial blood pressure (mmHg)

    Time frame: Peri-operatively

    Mean arterial blood pressure reading

  2. Heart rate (beat/minute)

    Time frame: Peri-operatively

    The number of hear beats per minute

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 29, 2017
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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