---
title: Labour Epidural Top-up With Warmed Ropivacaine
nct_id: NCT02838329
overall_status: UNKNOWN
phase: NA
sponsor: "Guy's and St Thomas' NHS Foundation Trust"
study_type: INTERVENTIONAL
primary_condition: Epidural Top-up
countries: United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02838329.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02838329"
ct_last_update_post_date: 2018-02-22
last_seen_at: "2026-05-12T07:09:38.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT02838329](https://clinicaltrials.gov/study/NCT02838329)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 90
- **Lead Sponsor:** Guy's and St Thomas' NHS Foundation Trust
- **Conditions:** Epidural Top-up, Labour, Caesarian Section, Ropivacaine
- **Start Date:** 2016-07
- **Completion Date:** 2018-12
- **CT.gov Last Update:** 2018-02-22

## 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

- **Sex:** 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
```

## Arms

- **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

## Interventions

- **warming of ropivacaine for BT** (OTHER)
- **Ropivicaine** (DRUG)

## Primary Outcomes

- **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)_

## 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)_

## Locations (1)

- St. Thomas' Hospital, London, United Kingdom — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.st. thomas' hospital|london||united kingdom` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02838329*  
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