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

NCT03110120 | Completed

• 1 other identifier: 2015/07JAN/008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Robotic Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• D1 pain intensity

  3 days

• morphine consumption

  5 days

• persistence of a chronic pain

  3 months

Study Arms (2)

serratus

ACTIVE COMPARATOR

Serratus plane block and local control

Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline; Drug: 0.5% levobupivacaine injectable solution with physiological saline

local

SHAM COMPARATOR

serratus control and local anesthesia

Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline; Drug: 0.5% levobupivacaine injectable solution with physiological saline

Interventions

0.5% levobupivacaine injectable solution with 10 ml of physiological saline DRUG

Serratus plane block realized with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline

Also known as: serratus plane block

serratus

0.5% levobupivacaine injectable solution with physiological saline DRUG

Serratus plane block realized with 20 ml of injectable solution of physiological saline

Also known as: local serratus

local

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• non robot-assisted surgery

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Watremez Christine

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Christine Watremez, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Compare the efficacy of the serratus plane block with local infiltration after thoracic robot-assisted surgery

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: April 12, 2017
• Study Start: May 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 10, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)