Labour Epidural Top-up With Warmed Ropivacaine (LETWR)

February 20, 2018 updated by: Guy's and St Thomas' NHS Foundation Trust

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: room temperature - RT
Ropivacaine used for Epidural top-up administered at room temperature
Drug: Ropivicaine
EXPERIMENTAL: body temperature BT
Ropivacaine used for Epidural top-up administered warmed to body temperature
Drug: Ropivicaine
Other: warming of ropivacaine for BT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to onset of surgical anaesthesia - loss of sensation to cold at T4 bilaterally as assessed with ethyl-chloride spray.
Time Frame: up to 30 min
up to 30 min

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: intraoperative
intraoperative
Quality of block during surgery - incidence of repeated top-up, intravenous opioids, inhaled nitrous oxide, conversion to spinal or general anaesthesia
Time Frame: intraoperative
intraoperative
Intensity of motor block - Bromage scale 3
Time Frame: up to 30 min
up to 30 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Investigators

  • Principal Investigator: Kate Cheesman, MBBS, Guy's and St Thomas NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (ESTIMATE)

July 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 189493

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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