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

• ClinicalTrials.gov Identifier: NCT03356899
• Recruitment Status: Completed
• First Posted: November 29, 2017
• Last Update Posted: April 30, 2019
• Sponsor: Menoufia University
• Information provided by (Responsible Party): Dr Ezzeldin Ibrahim, Menoufia University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cesarean Section; Shivering	Drug: Low dose bupivacaine 0.5% (8mg); Drug: High dose bupivacaine 0.5% (10mg)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Dosage of Intrathecal Hyperbaric Bupivacaine and the Incidence of Post Spinal Shivering in Cesarean Section: is There a Relation?
• Actual Study Start Date: December 30, 2017
• Actual Primary Completion Date: August 29, 2018
• Actual Study Completion Date: September 29, 2018

Arms and Interventions

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 Name: 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 Name: Bupivacaine for spinal anaesthesia

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 22 Years to 35 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: All patients were females scheduled for elective caesarian section.
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Egypt

Faculty of Medicine, Menoufia Univeristy

Shibīn Al Kawm, Egypt

Sponsors and Collaborators

Menoufia University

Investigators

• Principal Investigator: Ezzeldin Ibrahim, PhD; Professor

More Information

• Responsible Party: Dr Ezzeldin Ibrahim, Assistant Professor in anaesthesia, intensive care, and pain medicine., Menoufia University
• ClinicalTrials.gov Identifier: NCT03356899
• Other Study ID Numbers: MenoufiaU2015/2
• First Posted: November 29, 2017
• Last Update Posted: April 30, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Bupivacaine; Anesthetics; Anesthetics, Local; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents