---
title: The Hemodynamic Effect Between Two Types of Anesthesia in Esophageal Surgery
nct_id: NCT03185403
overall_status: COMPLETED
phase: NA
sponsor: University Hospital, Lille
study_type: INTERVENTIONAL
primary_condition: Epidural Block
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03185403.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03185403"
ct_last_update_post_date: 2017-06-14
last_seen_at: "2026-05-12T06:16:15.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Hemodynamic Effect Between Two Types of Anesthesia in Esophageal Surgery

**Official Title:** Comparison of the Hemodynamic Effect Between the Paravertebral Block and Thoracic Epidural in Esophageal Surgery With Thoracotomy .

**NCT ID:** [NCT03185403](https://clinicaltrials.gov/study/NCT03185403)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 54
- **Lead Sponsor:** University Hospital, Lille
- **Conditions:** Epidural Block, Oesophageal Cancer, Oesophagectomy
- **Start Date:** 2013-12
- **Completion Date:** 2017-01
- **CT.gov Last Update:** 2017-06-14

## Brief Summary

Continuous Paravertebral block (PVB) was reported to provide less episodes of hypotension than continuous thoracic epidural block (TEB). The maintenance of optimal tissue perfusion is essential for esophageal anastomosis in patients undergoing oesophagectomy. the aim of this study is to compare Hemodynamic effect of continous PVB compared to TEB , in patient undergoing oesophagectomy with laparoscopy and thoracotomy.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* ASA score 1 to 3
* oesophagectomy : abdominal time with laparoscopy ans thoracic time with thoracotomy

Exclusion Criteria:

* pregnancy
* Uncooperative patient
* patient refusal
* Coagulopathy
* allergy to local anesthetic
* Psychological Disorders
* Failure to install the epidural or paravertebral catheter. The patient will therefore be excluded secondarily but will be able to benefit from an alternative technique for the management of his pain.
* Sepsis
* Skin infection at the puncture site
* Allergy to local anesthetics
* Esophagectomy with cervical surgical time
* Patient with chronic pain EVA\> 4 before surgery.
```

## Arms

- **continous paravertebral block** (ACTIVE_COMPARATOR) — echoguided thoracic continous paravertebral block was placed before the surgery.

A bolus of 5 ml of ropivacaine 0.2% and 10µg of Sufentanil was injected in the catheter at the end of the abdominal time. A continuous infusion of ropivacaine 0.2% at 4ml/h was then initiated at the thoracic time. Postoperative patient-controlled analgesia consisted on an infusion of ropivacaine 0.2% at 6ml/h and a permitted bolus of 4ml every 15min as required.
- **continous Thoracic epidural block** (ACTIVE_COMPARATOR) — thoracic epidural catheter was inserted before the surgery. A bolus of 5 ml of ropivacaine 0.2% and 10µg of Sufentanil was injected in the catheter at the end of the abdominal time. A continuous infusion of ropivacaine 0.2% at 4ml/h was then initiated at the thoracic time. Postoperative patient-controlled analgesia consisted on an infusion of ropivacaine 0.2% at 6ml/h and a permitted bolus of 4ml every 15min as required.

## Interventions

- **paravertebral block** (OTHER) — in the paravertebral block , the catheter was placed under ultrasound echography , at the right thoracic T4/T5 level
- **thoracic epidural block** (OTHER) — in the epidural block the catheter was inserted without echography , at T4/T5 level
- **ropivacaine** (DRUG)
- **Sufentanil** (DRUG)

## Primary Outcomes

- **Frequency of hypotension episodes** _(time frame: during perioperative until first 24 hours post operative)_ — The frequency of hypotension episodes defined by a mean arterial pressure (MAP) less than 70mmHg or a decrease in MAP greater than 20% when compared with the preoperative value

## Secondary Outcomes

- **Total amount per patient and per group of vasopressins amines** _(time frame: during perioperative until first 24 hours post operative)_
- **Frequency of use of vasopressor agents** _(time frame: during perioperative until first 24 hours post operative)_
- **Volumes of fluid administered** _(time frame: during perioperative until the first 24h hours post operative)_
- **total amount of morphine consumption** _(time frame: during first 48 hours post operative)_
- **visual analog scale** _(time frame: during first 48 hours post operative, at 3 months and 6 months)_
- **DN2 score** _(time frame: during first 48 hours post operative, at 3 months and 6 months)_
- **Frequency of surgical complications** _(time frame: during first 48 hours post operative)_
- **Frequency of pulmonary complications** _(time frame: during first 48 hours post operative)_
- **total amount and frequency of Post-operative anti-emetic consumption** _(time frame: during first 48 hours post operative)_
- **Death** _(time frame: up to 28 days postoperative)_

## Locations (1)

- CHRU , Hôpital Claude Huriez, Lille, France

## Recent Field Changes (last 30 days)

- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.chru , hôpital claude huriez|lille||france` — added _(2026-05-12)_
- `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.minAge` — 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)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03185403*  
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