Analgesia, Robotic Surgery
Conditions
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.
Interventions
DRUG0.5% 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
DRUG0.5% levobupivacaine injectable solution with physiological saline
Serratus plane block realized with 20 ml of injectable solution of physiological saline
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes 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
Intervention model description
Compare the efficacy of the serratus plane block with local infiltration after thoracic robot-assisted surgery
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* mitral repair, coronary artery revascularization or thoracic surgery scheduled robot-assisted surgery
Exclusion criteria
* non robot-assisted surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium
Outcome results
None listed