Epidural Top-up, Labour, Caesarian Section, Ropivacaine
Conditions
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
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.
Interventions
OTHERwarming of ropivacaine for BT
DRUGRopivicaine
Sponsors
Guy's and St Thomas' NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| 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 | 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 |
Countries
United Kingdom
Contacts
Primary ContactAsta Lukosiute, MBBS
Outcome results
None listed