NCT02838329

Labour Epidural Top-up With Warmed Ropivacaine

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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

• Epidural Top-up
• Labour
• Caesarian Section
• Ropivacaine

Interventions

Type	Name	Description
OTHER	warming of ropivacaine for BT
DRUG	Ropivicaine

Timeline

• Start date: 2016-07-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2016-07-20
• Last updated: 2018-02-22

Locations

1 site across 1 country: United Kingdom