Labour Epidural Top-up With Warmed Ropivacaine

Study Overview
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Brief Summary
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The purpose of this study is to determine weather using warmed (body temperature) 0.75% Ropivicaine to convert labour epidural analgesia to surgical anaesthesia, reduces the onset time of surgical block, compared to standard room temperature

Detailed Description
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In this prospective, randomised, controlled, double-blind study; parturients with functioning labour epidural analgesia requiring conversion to anaesthesia for surgical delivery (SD) - will be randomised into control and intervention groups: room temperature (RT) and body temperature (BT). The control group (RT) will receive room temperature Ropivacaine 0.75%, as is the standard practice. The treatment group (BT) will receive 0.75% Ropivicaine warmed up to 37°C temperature. Block height will be assessed every 2 minutes by a blinded investigator until the loss of sensation to cold at the level of T4, sensation to touch will be used as second modality. Primary outcome is the time to loss of sensation to cold at T4 bilaterally as assessed with ethyl-chloride spray. Secondary outcomes will include motor block, haemodynamic stability, and use of vasopressors, shivering, sweating, nausea, pruritus, body temperature, intra-operative supplementation, and Apgar scores.

Official Title
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The Effect of the Body Temperature 0.75% Ropivacaine on the Time to Convert Labour Epidural Analgesia to Anaesthesia for Surgical Delivery

Conditions
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Epidural Top-up, Labour, Caesarian Section, Ropivacaine

Intervention / Treatment
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* Other: warming of ropivacaine for BT
* Drug: Ropivicaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II women with an established labour epidural Labour analgesia with standard low-dose mixture PCEA Need for surgical delivery Exclusion Criteria: Category 1 (crash) CS Spinal blockade, suggesting migration of epidural catheter Use of epidural bupivacaine 0.25-0.5% within 1 h Pyrexial parturian - ≥38°C temperature before administration of top-up Multiply pregnancy Eclampsia An allergy or idiosyncratic reaction to local anaesthetic Patient refusal
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: room temperature - RT<br>Ropivacaine used for Epidural top-up administered at room temperature | Drug: Ropivicaine<br> <br> |
| Experimental: body temperature BT<br>Ropivacaine used for Epidural top-up administered warmed to body temperature | Other: warming of ropivacaine for BT<br> <br> Drug: Ropivicaine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to onset of surgical anaesthesia - loss of sensation to cold at T4 bilaterally as assessed with ethyl-chloride spray. |  | up to 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects: itching, shivering, nausea, vomiting measured on a four-point scale (0=none, 1=mild, 2=moderate, 3=severe), drop of SBP >20% of the baseline and need for vasopressors during the surgery |  | intraoperative | 
| Quality of block during surgery - incidence of repeated top-up, intravenous opioids, inhaled nitrous oxide, conversion to spinal or general anaesthesia |  | intraoperative | 
| Intensity of motor block - Bromage scale 3 |  | up to 30 min |