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

Not Applicable

Completed

• Conditions: Cesarean Section; Shivering
• Interventions: Drug: Low dose bupivacaine 0.5% (8mg); Drug: High dose bupivacaine 0.5% (10mg)

• Registration Number: NCT03356899
• Lead Sponsor: Menoufia University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-11-23
• Study First Submitted QC: 2017-11-28
• Study First Posted: 2017-11-29
• Study Start: 2017-12-30
• Primary Completion: 2018-08-29
• Study Completion: 2018-09-29
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-26
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low dose bupivacaine 0.5% (8mg)	Low dose bupivacaine 0.5% (8mg)	Bupivacaine 0.5% for spinal anesthesia
High dose bupivacaine 0.5% (10mg)	High dose bupivacaine 0.5% (10mg)	Bupivacaine 0.5% for spinal anesthesia

Primary Outcome Measures

Name	Time	Method
Shivering score	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 Outcome Measures

Name	Time	Method
Mean arterial blood pressure (mmHg)	Peri-operatively	Mean arterial blood pressure reading
Heart rate (beat/minute)	Peri-operatively	The number of hear beats per minute

Trial Locations

Locations (1)

Faculty of Medicine, Menoufia Univeristy; 🇪🇬 Shibīn Al Kawm, Egypt