Labour Epidural Top-up With Warmed Ropivacaine
LETWR
The Effect of the Body Temperature 0.75% Ropivacaine on the Time to Convert Labour Epidural Analgesia to Anaesthesia for Surgical Delivery
1 other identifier
interventional
90
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 18, 2016
CompletedFirst Posted
Study publicly available on registry
July 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 22, 2018
February 1, 2018
2.4 years
July 18, 2016
February 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
room temperature - RT
ACTIVE COMPARATORRopivacaine used for Epidural top-up administered at room temperature
body temperature BT
EXPERIMENTALRopivacaine used for Epidural top-up administered warmed to body temperature
Interventions
Eligibility Criteria
You may qualify if:
- ASA I-II women with an established labour epidural
- Labour analgesia with standard low-dose mixture PCEA
- Need for surgical delivery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Thomas' Hospital
London, Se1 7EH, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Kate Cheesman, MBBS
Guy's and St Thomas NHS foundation trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2016
First Posted
July 20, 2016
Study Start
July 1, 2016
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
February 22, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share