Labour Epidural Top-up With Warmed Ropivacaine

Not Applicable

• Conditions: Epidural Top-up; Labour; Caesarian Section; Ropivacaine
• Interventions: Drug: Ropivicaine; Other: warming of ropivacaine for BT

• Registration Number: NCT02838329
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief 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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-19
• Study First Posted: 2016-07-20
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-02-22
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
room temperature - RT	Ropivicaine	Ropivacaine used for Epidural top-up administered at room temperature
body temperature BT	warming of ropivacaine for BT	Ropivacaine used for Epidural top-up administered warmed to body temperature
body temperature BT	Ropivicaine	Ropivacaine used for Epidural top-up administered warmed to body temperature

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

St. Thomas' Hospital; 🇬🇧 London, United Kingdom