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

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

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Shivering
• Intervention / Treatment: Drug: Low dose bupivacaine 0.5% (8mg); Drug: High dose bupivacaine 0.5% (10mg)

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Shibīn Al Kawm, Egypt
    • Faculty of Medicine, Menoufia Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Low dose bupivacaine 0.5% (8mg); Bupivacaine 0.5% for spinal anesthesia	Drug: Low dose bupivacaine 0.5% (8mg); 8 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.1 ml; Other Names: Bupivacaine for spinal anaesthesia.
ACTIVE_COMPARATOR: High dose bupivacaine 0.5% (10mg); Bupivacaine 0.5% for spinal anesthesia	Drug: High dose bupivacaine 0.5% (10mg); 10 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.5; Other Names: Bupivacaine for spinal anaesthesia

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Principal Investigator: Ezzeldin Ibrahim, PhD, PROFESSOR

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 30, 2017
• Primary Completion (ACTUAL): August 29, 2018
• Study Completion (ACTUAL): September 29, 2018

Study Registration Dates

• First Submitted: November 23, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (ACTUAL): November 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 26, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Local; Anesthetics; Bupivacaine
• Other Study ID Numbers: MenoufiaU2015/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No