Interest of Serratus Plane Block in Postoperative Analgesia for Robot-assisted Surgery

Analgesia Clinical Trial

Official title:

Interest of Serratus Plane Block in Postoperative Analgesia for Patients Undergoing Robot-assisted Mitral Valve Repair, MIDCAB or Partial Lung Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03110120
• Other study ID #: 2015/07JAN/008
• 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
• 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

Related Conditions & MeSH terms

• Analgesia
• Robotic Surgery

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