Labour Epidural Top-up With Warmed Ropivacaine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-12-31

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

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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.

Conditions

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Epidural Top-up Labour Caesarian Section Ropivacaine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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room temperature - RT

Ropivacaine used for Epidural top-up administered at room temperature

Group Type ACTIVE_COMPARATOR

Ropivicaine

Intervention Type DRUG

body temperature BT

Ropivacaine used for Epidural top-up administered warmed to body temperature

Group Type EXPERIMENTAL

warming of ropivacaine for BT

Intervention Type OTHER

Ropivicaine

Intervention Type DRUG

Interventions

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warming of ropivacaine for BT

Intervention Type OTHER

Ropivicaine

Intervention Type DRUG

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No