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

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Robotic Surgery
• Intervention / Treatment: Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline; Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline; Drug: 0.5% levobupivacaine injectable solution with physiological saline; Drug: 0.5% levobupivacaine injectable solution with physiological saline

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1200
    • Watremez Christine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• non robot-assisted surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: serratus; Serratus plane block and local control	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; Other Names: serratus plane block; Drug: 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; Other Names: local anesthesia; Drug: 0.5% levobupivacaine injectable solution with physiological saline; Serratus plane block realized with 20 ml of injectable solution of physiological saline; Other Names: local serratus; Drug: 0.5% levobupivacaine injectable solution with physiological saline; local infiltration of the wound with 20 ml of injectable solution of physiological saline; Other Names: local control
Sham Comparator: local; serratus control and local anesthesia	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; Other Names: serratus plane block; Drug: 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; Other Names: local anesthesia; Drug: 0.5% levobupivacaine injectable solution with physiological saline; Serratus plane block realized with 20 ml of injectable solution of physiological saline; Other Names: local serratus; Drug: 0.5% levobupivacaine injectable solution with physiological saline; local infiltration of the wound with 20 ml of injectable solution of physiological saline; Other Names: local control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
morphine consumption	Consumption of morphine the day and 4 days after surgery as recorded on the PCA.	5 days
persistence of a chronic pain	Phone call 3 month after surgery to evaluate the persistence of pain	3 months

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Christine Watremez, MD, PhD, Cliniques Universitaires Saint-luc

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): October 10, 2017
• Last Update Submitted That Met QC Criteria: October 7, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Levobupivacaine
• Other Study ID Numbers: 2015/07JAN/008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No