HEMOBLOC: The Hemodynamic Effect Between Two Types of Anesthesia in Esophageal Surgery

Sponsor

University Hospital, Lille (Other)

Overall Status

Completed

CT.gov ID

NCT03185403

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epidural Block Oesophageal Cancer Oesophagectomy	Other: paravertebral block Other: thoracic epidural block Drug: ropivacaine Drug: Sufentanil	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: continous paravertebral block 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 in the paravertebral block , the catheter was placed under ultrasound echography , at the right thoracic T4/T5 level Drug: ropivacaine Drug: Sufentanil
Active Comparator: continous Thoracic epidural block 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 in the epidural block the catheter was inserted without echography , at T4/T5 level Drug: ropivacaine Drug: Sufentanil

Arm

Intervention/Treatment

Active Comparator: continous paravertebral block

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

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

Drug: ropivacaine

Drug: Sufentanil

Active Comparator: continous Thoracic epidural block

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

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

Drug: ropivacaine

Drug: Sufentanil

Outcome Measures

Primary Outcome Measures

Frequency of hypotension episodes [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 Outcome Measures

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]
Measure the pain severity
DN2 score [during first 48 hours post operative, at 3 months and 6 months]
evaluation with validated scores for chronic and neuropathic pains
Frequency of surgical complications [during first 48 hours post operative]
Frequency of pulmonary complications [during first 48 hours post operative]
total amount and frequency of Post-operative anti-emetic consumption [during first 48 hours post operative]
Death [up to 28 days postoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU , Hôpital Claude Huriez	Lille		France

Sponsors and Collaborators

University Hospital, Lille

Investigators

Principal Investigator: Gilles Lebuffe, MD, PhD, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

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. Epub 2006 Feb 13. Review. Erratum in: Br J Anaesth. 2007 Nov;99(5):768.

Responsible Party:

University Hospital, Lille

ClinicalTrials.gov Identifier:

NCT03185403

Other Study ID Numbers:

2012_47
2013-002317-36

First Posted:

Jun 14, 2017

Last Update Posted:

Jun 14, 2017

Last Verified:

Jun 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Lille

hemodynamic effect

para vertebral block

Additional relevant MeSH terms:

Sufentanil

Ropivacaine

Study Results

No Results Posted as of Jun 14, 2017