The Hemodynamic Effect Between Two Types of Anesthesia in Esophageal Surgery

NCT03185403 | Completed

• 2 other identifiers: 2012_472013-002317-36
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Epidural Block; Oesophageal Cancer; Oesophagectomy

Keywords

hemodynamic effect; para vertebral block

Outcome Measures

Primary Outcomes (1)

• Frequency of hypotension episodes

  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

  during perioperative until first 24 hours post operative

Secondary Outcomes (10)

• Total amount per patient and per group of vasopressins amines

  during perioperative until first 24 hours post operative

• Frequency of use of vasopressor agents

  during perioperative until first 24 hours post operative

• Volumes of fluid administered

  during perioperative until the first 24h hours post operative

• total amount of morphine consumption

  during first 48 hours post operative

• visual analog scale

  during first 48 hours post operative, at 3 months and 6 months

Study Arms (2)

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.

Other: paravertebral block; Drug: ropivacaine; Drug: Sufentanil

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.

Other: thoracic epidural block; Drug: ropivacaine; Drug: Sufentanil

Interventions

paravertebral block OTHER

in the paravertebral block , the catheter was placed under ultrasound echography , at the right thoracic T4/T5 level

continous paravertebral block

thoracic epidural block OTHER

in the epidural block the catheter was inserted without echography , at T4/T5 level

continous Thoracic epidural block

ropivacaine DRUG

continous Thoracic epidural block; continous paravertebral block

Sufentanil DRUG

continous Thoracic epidural block; continous paravertebral block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

CHRU , Hôpital Claude Huriez

Lille, France

Location

Related Publications (1)

• Davies RG, Myles PS, Graham JM. A comparison of the analgesic efficacy and side-effects of paravertebral vs epidural blockade for thoracotomy--a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2006 Apr;96(4):418-26. doi: 10.1093/bja/ael020. Epub 2006 Feb 13.

  PMID: 16476698 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Ropivacaine; Sufentanil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gilles Lebuffe, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 14, 2017
• Study Start: December 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: January 1, 2017
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)