Labour Epidural Top-up With Warmed Ropivacaine (LETWR)

Guy's and St Thomas' NHS Foundation Trust

Status: Unknown

Conditions: Epidural Top-up; Ropivacaine; Caesarian Section; Labour

Treatments: Other: warming of ropivacaine for BT; Drug: Ropivicaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02838329

189493

Details and patient eligibility

About

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

Full description

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.

Enrollment: 90 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

room temperature - RT

Active Comparator group

Description:

Ropivacaine used for Epidural top-up administered at room temperature

Treatment:

Drug: Ropivicaine

body temperature BT

Experimental group

Description:

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

Treatment:

Other: warming of ropivacaine for BT

Drug: Ropivicaine