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

Not Applicable

Completed

• Conditions: Analgesia; Robotic Surgery
• Interventions: Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline; Drug: 0.5% levobupivacaine injectable solution with physiological saline

• Registration Number: NCT03110120
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2017-03-08
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-12
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Last Update Submitted: 2017-10-07
• Last Update Posted: 2017-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• non robot-assisted surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
serratus	0.5% levobupivacaine injectable solution with 10 ml of physiological saline	Serratus plane block and local control
serratus	0.5% levobupivacaine injectable solution with physiological saline	Serratus plane block and local control
local	0.5% levobupivacaine injectable solution with physiological saline	serratus control and local anesthesia
local	0.5% levobupivacaine injectable solution with 10 ml of physiological saline	serratus control and local anesthesia

Primary Outcome Measures

Name	Time	Method
D0 pain intensity	1 day	Self reported pain intensity the day of surgery. Each item is scored 0-100 (0 - no pain, 100 - pain as bad as can be)

Secondary Outcome Measures

Name	Time	Method
D1 pain intensity	3 days	Self reported pain intensity the days after surgery. Each item is scored 0 - 100 (0 - no pain, 100 - pain as bad as can be)
morphine consumption	5 days	Consumption of morphine the day and 4 days after surgery as recorded on the PCA.
persistence of a chronic pain	3 months	Phone call 3 month after surgery to evaluate the persistence of pain

Trial Locations

Locations (1)

Watremez Christine; 🇧🇪 Bruxelles, Belgium