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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03110120
Other study ID # 2015/07JAN/008
Secondary ID
Status Completed
Phase N/A
First received March 8, 2017
Last updated October 7, 2017
Start date May 2015
Est. completion date June 2017

Study information

Verified date April 2017
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to compare the analgesia provided by the serratus plane block with local infiltration of the orifices of the trocars after thoracic robot-assisted surgery.


Description:

In our hospital, the current practice to provide post operative analgesia for patients scheduled for robot-assisted mitral repair or oncological thoracic surgery is to dispense local anesthetics at the orifices of the trocars at the end of the surgery and to give a Patient Controlled Analgesia (PCA). Some of these patients are not comfortable and we observe a large percentage of chronic pain. Recently we tried to use the Serratus plane block realised before the beginning of the surgery, and it seemed that patients were more comfortable with a lower consumption of morphine. So we decided to perform a double blind, randomized study in this population of patients to compare the analgesia provided by the serratus plane block realized before the beginning of the surgery and the local infiltration of the wound at the end of the surgery.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- mitral repair, coronary artery revascularization or thoracic surgery scheduled robot-assisted surgery

Exclusion Criteria:

- non robot-assisted surgery

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
0.5% levobupivacaine injectable solution with 10 ml of physiological saline
Serratus plane block realized with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline
0.5% levobupivacaine injectable solution with 10 ml of physiological saline
local infiltration of the wound with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline
0.5% levobupivacaine injectable solution with physiological saline
Serratus plane block realized with 20 ml of injectable solution of physiological saline
0.5% levobupivacaine injectable solution with physiological saline
local infiltration of the wound with 20 ml of injectable solution of physiological saline

Locations

Country Name City State
Belgium Watremez Christine Bruxelles

Sponsors (1)

Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary D0 pain intensity Self reported pain intensity the day of surgery. Each item is scored 0-100 (0 - no pain, 100 - pain as bad as can be) 1 day
Secondary D1 pain intensity Self reported pain intensity the days after surgery. Each item is scored 0 - 100 (0 - no pain, 100 - pain as bad as can be) 3 days
Secondary morphine consumption Consumption of morphine the day and 4 days after surgery as recorded on the PCA. 5 days
Secondary persistence of a chronic pain Phone call 3 month after surgery to evaluate the persistence of pain 3 months
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