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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| room temperature - RT | Active Comparator | Ropivacaine used for Epidural top-up administered at room temperature |
|
| body temperature BT | Experimental | Ropivacaine used for Epidural top-up administered warmed to body temperature |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| warming of ropivacaine for BT | Other |
| ||
| Ropivicaine |
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of surgical anaesthesia - loss of sensation to cold at T4 bilaterally as assessed with ethyl-chloride spray. | up to 30 min |
| Measure | Description | 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 | intraoperative | |
| Quality of block during surgery - incidence of repeated top-up, intravenous opioids, inhaled nitrous oxide, conversion to spinal or general anaesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asta Lukosiute, MBBS | Contact | astalukosiu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kate Cheesman, MBBS | Guy's and St Thomas NHS foundation trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Thomas' Hospital | Recruiting | London | Se1 7EH | United Kingdom |
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|
| intraoperative |
| Intensity of motor block - Bromage scale 3 | up to 30 min |