Epidural Top-upLETWRNCT02838329
Labour Epidural Top-up With Warmed Ropivacaine
A study testing warming of ropivacaine for BT and Ropivicaine in people with Epidural Top-up and Labour, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Epidural Top-up, Labour, Caesarian Section
- What is being tested?
- warming of ropivacaine for BT and Ropivicaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ASA I-II women with an established labour epidural
- Labour analgesia with standard low-dose mixture PCEA
- Need for surgical delivery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Asta Lukosiute, MBBS contact
United Kingdom1 site, 1 recruiting
- Recruiting
St. Thomas' Hospital
London, Se1 7EH
Kate Cheesman, consultant, Kate.Cheesman@gstt.nhs.uk
About this study
Official title: 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
Read the 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
- Being tested
- warming of ropivacaine for BT, Ropivicaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warming of ropivacaine for BTOther
RopivicaineDrug
| Study group | Role | What they receive |
|---|---|---|
| room temperature - RT | Active comparator | Ropivacaine used for Epidural top-up administered at room temperature Receives: Drug: Ropivicaine |
| body temperature BT | Experimental | Ropivacaine used for Epidural top-up administered warmed to body temperature Receives: Other: warming of ropivacaine for BT; Drug: Ropivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to onset of surgical anaesthesia - loss of sensation to cold at T4 bilaterally as assessed with ethyl-chloride spray.
Measured: 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
Measured: intraoperative
Quality of block during surgery - incidence of repeated top-up, intravenous opioids, inhaled nitrous oxide, conversion to spinal or general anaesthesia
Measured: intraoperative
Intensity of motor block - Bromage scale 3
Measured: up to 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural Top-upStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kate Cheesman, MBBS, Principal investigator, Guy's and St Thomas NHS foundation trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838329
- Sponsor's protocol ID
- 189493
- Acronym
- LETWR
- Status last verified
- Feb 2018
- First submitted
- 18 Jul 2016
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Body Temperature 0.75% Ropivacaine on the Time to Convert Labour Epidural Analgesia to Anaesthesia for Surgical Delivery
- ClinicalTrials.gov ID
- NCT02838329
- Acronym / sponsor ID
- LETWR / 189493
- Conditions
- Epidural Top-up, Labour, Caesarian Section, Ropivacaine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| room temperature - RT | Active comparator | Drug: RopivicaineRopivacaine used for Epidural top-up administered at room temperature |
| body temperature BT | Experimental | Other: warming of ropivacaine for BT, Drug: RopivicaineRopivacaine used for Epidural top-up administered warmed to body temperature |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-II women with an established labour epidural
- Labour analgesia with standard low-dose mixture PCEA
- Need for surgical delivery
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| warming of ropivacaine for BT | Other | body temperature BT |
| Ropivicaine | Drug | body temperature BT, room temperature - RT |
Primary outcome
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
3 secondary outcomes
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
Quality of block during surgery - incidence of repeated top-up, intravenous opioids, inhaled nitrous oxide, conversion to spinal or general anaesthesia
Time frame: intraoperative
Intensity of motor block - Bromage scale 3
Time frame: up to 30 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Epidural Top-up
Not yet recruitingObservational study
Management of Indwelling Labor Epidural Catheters for Cesarean Delivery
Intraoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asta Lukosiute, MBBS contact
Kate Cheesman, MBBS principal investigator
Guy's and St Thomas NHS foundation trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing warming of ropivacaine for BT and Ropivicaine in people with Epidural Top-up and Labour, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asta Lukosiute, MBBS (astalukosiu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.