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

Primary Purpose

Analgesia, Robotic Surgery

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
0.5% levobupivacaine injectable solution with 10 ml of physiological saline
0.5% levobupivacaine injectable solution with 10 ml of physiological saline
0.5% levobupivacaine injectable solution with physiological saline
0.5% levobupivacaine injectable solution with physiological saline
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • non robot-assisted surgery

Sites / Locations

  • Watremez Christine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

serratus

local

Arm Description

Serratus plane block and local control

serratus control and local anesthesia

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
morphine consumption
Consumption of morphine the day and 4 days after surgery as recorded on the PCA.
persistence of a chronic pain
Phone call 3 month after surgery to evaluate the persistence of pain

Full Information

First Posted
March 8, 2017
Last Updated
October 7, 2017
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT03110120
Brief Title
Interest of Serratus Plane Block in Postoperative Analgesia for Robot-assisted Surgery
Official Title
Interest of Serratus Plane Block in Postoperative Analgesia for Patients Undergoing Robot-assisted Mitral Valve Repair, MIDCAB or Partial Lung Resection
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Robotic Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Compare the efficacy of the serratus plane block with local infiltration after thoracic robot-assisted surgery
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The patient where randomized by the investigator after inform consent was signed The investigator prepared the syringes named "serratus" and "local" with levobupivacaine 0.25 or saline according to randomization The care provider injected the prepared syringes respectively in the serratus plane or locally without knowing their contents The outcome assessor evaluated the post operative pain and the 3 months followup without knowing the randomization
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
serratus
Arm Type
Active Comparator
Arm Description
Serratus plane block and local control
Arm Title
local
Arm Type
Sham Comparator
Arm Description
serratus control and local anesthesia
Intervention Type
Drug
Intervention Name(s)
0.5% levobupivacaine injectable solution with 10 ml of physiological saline
Other Intervention Name(s)
serratus plane block
Intervention Description
Serratus plane block realized with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline
Intervention Type
Drug
Intervention Name(s)
0.5% levobupivacaine injectable solution with 10 ml of physiological saline
Other Intervention Name(s)
local anesthesia
Intervention Description
local infiltration of the wound with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline
Intervention Type
Drug
Intervention Name(s)
0.5% levobupivacaine injectable solution with physiological saline
Other Intervention Name(s)
local serratus
Intervention Description
Serratus plane block realized with 20 ml of injectable solution of physiological saline
Intervention Type
Drug
Intervention Name(s)
0.5% levobupivacaine injectable solution with physiological saline
Other Intervention Name(s)
local control
Intervention Description
local infiltration of the wound with 20 ml of injectable solution of physiological saline
Primary Outcome Measure Information:
Title
D0 pain intensity
Description
Self reported pain intensity the day of surgery. Each item is scored 0-100 (0 - no pain, 100 - pain as bad as can be)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
D1 pain intensity
Description
Self reported pain intensity the days after surgery. Each item is scored 0 - 100 (0 - no pain, 100 - pain as bad as can be)
Time Frame
3 days
Title
morphine consumption
Description
Consumption of morphine the day and 4 days after surgery as recorded on the PCA.
Time Frame
5 days
Title
persistence of a chronic pain
Description
Phone call 3 month after surgery to evaluate the persistence of pain
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: mitral repair, coronary artery revascularization or thoracic surgery scheduled robot-assisted surgery Exclusion Criteria: non robot-assisted surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Watremez, MD, PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Watremez Christine
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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