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Completed

NCT Number: NCT03185403

The Hemodynamic Effect Between Two Types of Anesthesia in Esophageal Surgery

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.

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Key information

Conditions

Epidural Block Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Oesophageal Cancer Oesophagectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU , Hôpital Claude Huriez

Lille, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. 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

  1. Total amount per patient and per group of vasopressins amines

    Time frame: during perioperative until first 24 hours post operative

  2. Frequency of use of vasopressor agents

    Time frame: during perioperative until first 24 hours post operative

  3. Volumes of fluid administered

    Time frame: during perioperative until the first 24h hours post operative

  4. total amount of morphine consumption

    Time frame: during first 48 hours post operative

  5. visual analog scale

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

    Measure the pain severity

  6. DN2 score

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

    evaluation with validated scores for chronic and neuropathic pains

  7. Frequency of surgical complications

    Time frame: during first 48 hours post operative

  8. Frequency of pulmonary complications

    Time frame: during first 48 hours post operative

  9. total amount and frequency of Post-operative anti-emetic consumption

    Time frame: during first 48 hours post operative

  10. Death

    Time frame: up to 28 days postoperative

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: HEMOBLOC

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jun 14, 2017
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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