Clinical trial NCT02838329: Labour Epidural Top-up With Warmed Ropivacaine
Official title: The Effect of the Body Temperature 0.75% Ropivacaine on the Time to Convert Labour Epidural Analgesia to Anaesthesia for Surgical Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epidural Top-up
Labour
Caesarian Section
Ropivacaine
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 90
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to onset of surgical anaesthesia - loss of sensation to cold at T4 bilaterally as assessed with ethyl-chloride spray.
timeFrame: up to 30 min
Secondary outcomes:
measure: 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
timeFrame: intraoperative
measure: Quality of block during surgery - incidence of repeated top-up, intravenous opioids, inhaled nitrous oxide, conversion to spinal or general anaesthesia
timeFrame: intraoperative
measure: Intensity of motor block - Bromage scale 3
timeFrame: up to 30 min
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St. Thomas' Hospital
Study officials:
affiliation: Guy's and St Thomas NHS foundation trust
name: Kate Cheesman, MBBS
role: PRINCIPAL_INVESTIGATOR
References: