Epidural BlockHEMOBLOCNCT03185403
The Hemodynamic Effect Between Two Types of Anesthesia in Esophageal Surgery
A study testing paravertebral block, thoracic epidural block and ropivacaine in people with Epidural Block and Oesophageal Cancer, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epidural Block, Oesophageal Cancer, Oesophagectomy
- What is being tested?
- paravertebral block, thoracic epidural block and ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA score 1 to 3
- oesophagectomy : abdominal time with laparoscopy ans thoracic time with thoracotomy
Who cannot join
- pregnancy
- Uncooperative patient
- patient refusal
- Coagulopathy
- allergy to local anesthetic
- Psychological Disorders
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Hemodynamic Effect Between the Paravertebral Block and Thoracic Epidural in Esophageal Surgery With Thoracotomy .
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
- Being tested
- paravertebral block, thoracic epidural block, ropivacaine, Sufentanil
- Keywords
- hemodynamic effect, para vertebral block
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paravertebral blockOther
in the paravertebral block , the catheter was placed under ultrasound echography , at the right thoracic T4/T5 level
thoracic epidural blockOther
in the epidural block the catheter was inserted without echography , at T4/T5 level
ropivacaineDrug
SufentanilDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: thoracic epidural block; Drug: ropivacaine; Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during perioperative until first 24 hours post operative
Secondary outcomes (10)
Total amount per patient and per group of vasopressins amines
Measured: during perioperative until first 24 hours post operative
Frequency of use of vasopressor agents
Measured: during perioperative until first 24 hours post operative
Volumes of fluid administered
Measured: during perioperative until the first 24h hours post operative
total amount of morphine consumption
Measured: during first 48 hours post operative
visual analog scale
Measure the pain severity
Measured: during first 48 hours post operative, at 3 months and 6 months
DN2 score
evaluation with validated scores for chronic and neuropathic pains
Measured: during first 48 hours post operative, at 3 months and 6 months
Frequency of surgical complications
Measured: during first 48 hours post operative
Frequency of pulmonary complications
Measured: during first 48 hours post operative
total amount and frequency of Post-operative anti-emetic consumption
Measured: during first 48 hours post operative
Death
Measured: up to 28 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study startDec 2013
- Primary completionJul 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epidural BlockStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Lebuffe, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185403
- Sponsor's protocol ID
- 2012_47
- Other IDs
- 2013-002317-36
- Acronym
- HEMOBLOC
- Status last verified
- Jun 2017
- First submitted
- 30 May 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. doi: 10.1093/bja/ael020. Epub 2006 Feb 13.
PubMed 16476698
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Hemodynamic Effect Between the Paravertebral Block and Thoracic Epidural in Esophageal Surgery With Thoracotomy .
- ClinicalTrials.gov ID
- NCT03185403
- Acronym / sponsor ID
- HEMOBLOC / 2012_47
- Conditions
- Epidural Block, Oesophageal Cancer, Oesophagectomy
- Keywords
- hemodynamic effect, para vertebral block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continous paravertebral block | Active comparator | Other: paravertebral block, Drug: ropivacaine, Drug: Sufentanilechoguided 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 | Other: thoracic epidural block, Drug: ropivacaine, Drug: Sufentanilthoracic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA score 1 to 3
- oesophagectomy : abdominal time with laparoscopy ans thoracic time with thoracotomy
Key exclusion criteria (12 listed)
- pregnancy
- Uncooperative patient
- patient refusal
- Coagulopathy
- allergy to local anesthetic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paravertebral blockin the paravertebral block , the catheter was placed under ultrasound echography , at the right thoracic T4/T5 level | Other | continous paravertebral block |
| thoracic epidural blockin the epidural block the catheter was inserted without echography , at T4/T5 level | Other | continous Thoracic epidural block |
| ropivacaine | Drug | continous Thoracic epidural block, continous paravertebral block |
| Sufentanil | Drug | continous Thoracic epidural block, continous paravertebral block |
Primary outcome
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
10 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Background: PubMed 16476698Davies 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Lebuffe, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paravertebral block, thoracic epidural block and ropivacaine in people with Epidural Block and Oesophageal Cancer, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of hypotension episodes (time frame: during perioperative until first 24 hours post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03185403, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.