Labour Epidural Top-up With Warmed Ropivacaine

Ropivacaine Clinical Trial

— LETWR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02838329
• Other study ID #: 189493
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2016
• Last updated: February 20, 2018
• Start date: July 2016
• Est. completion date: December 2018

Study information

• Verified date: February 2018
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Asta Lukosiute, MBBS
• Email: astalukosiu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• warming of ropivacaine for BT

Drug:
• Ropivicaine

Locations

Country	Name	City	State
United Kingdom	St. Thomas' Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Quality of block during surgery - incidence of repeated top-up, intravenous opioids, inhaled nitrous oxide, conversion to spinal or general anaesthesia		intraoperative
Secondary	Intensity of motor block - Bromage scale 3		up to 30 min