Effect of Different Injection Speeds for Spinal Anaesthesia in Caesarean Section

Study Overview
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Brief Summary
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The purpose of this study is to investigate if prolonging the speed of injection during spinal anaesthesia can reduce the incidence of hypotension and/or medication requirements thereby making it safer for the mother and foetus.

Detailed Description
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We plan to investigate if by varying the speed of injection during spinal anaesthesia, will there be a difference in the incidence of hypotension. Hypotension is a common complication especially for pregnant women undergoing caesarean section. A high speed of injection can theoretically cause a higher spread of anaesthetic, which may increase the incidence of hypotension. We want to know if by prolonging the injection time, will this lead to a reduction in a rate of hypotension.

Official Title
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Injection Speed of Spinal Anaesthesia for Asian Women Undergoing Lower Segmental Caesarean Section and the Incidence of Hypotension and/or Use of Vasopressors

Conditions
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Pregnancy, Effects of; Anesthesia, Spinal and Epidural; in Pregnancy

Intervention / Treatment
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* Procedure: Slow Speed of spinal injection
* Procedure: Fast Speed of spinal injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years of age singleton term pregnancy American Society of Anesthesiologists (ASA) class I-II Exclusion Criteria: Severe pre-eclampsia contraindications to spinal anaesthesia Height <150cm or >180cm Weight ≥100kg Baseline systolic BP <90 mmHg Baseline systolic BP >150mmHg Category 1 urgency for delivery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Slow Speed<br>Slow group patients will receive spinal injection over 60 seconds. Vital signs monitored every minute after injection. Hypotension is treated with IV Phenylephrine or Ephedrine. | Procedure: Slow Speed of spinal injection<br>* Speed of injection over 60 seconds<br>|
| Experimental: Fast Speed<br>Fast group patients will receive spinal injection over 15 seconds. Vital signs monitored every minute after injection. Hypotension is treated with IV Phenylephrine or Ephedrine. | Procedure: Fast Speed of spinal injection<br>* Speed of injection over 15 seconds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Hypotension | How many patients will experience a drop in systolic Blood Pressure of greater than 20% | First 10 minutes after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of vasoconstrictors |  | First 10 minutes after injection | 
| Adequacy of block | To determine if the anaesthetic is adequate for the surgery (no pain or movement experienced around the surgical field) | Time of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower Segmental Caesarean Section (LSCS), Speed of Injection, Spinal Anaesthesia, Anesthesia