Pharmacokinetic Analysis, Post-operative Chronic Pain, Post-operative Pain, Regional Anesthesia, Serratus Anterior Plane Block, Thoracic Surgery
Conditions
Brief summary
The objective of the study is to compare the efficacy of the Serratus Anterior Plane block (SPB) realised in its deep plane, with a multi-holed catheter in place for twenty four hours, to a standard intravenous analgesia for small videoassisted thoracic surgery interventions. The objective is also to evaluate the resorption rate of local anesthetic at this level, and make a population pharmacokinetic analysis.
Detailed description
In this study, 20 patients will be randomly assigned to one of two groups: ten patients will have a Serratus anterior plane block (SPB), with a first ropivacaine 0,375% bolus (0,4ml/kg), followed by an infusion of ropivacaine 0,2% at a 10ml/hr rate, through a multi-holed catheter located under the serratus anterior muscle, for a duration of 24 hours. The other group will have a standard intravenous analgesia with a PCA morphine-dehydrobenzperidol pump. Anesthesia protocol will be standardized. Except the infusion of ropivacaine for the SPB, per operative anesthesia and post operative analgesia will be the same for every usual patients. The investigators will evaluate post operative pain based on the visual analog scale, 24 hours morphine consumption, sensitivity of concerned territory. The investigators will also evaluate post operative chronic pain by assessing pain two months post operatively, completing two questionnaires of neuropathic pain: DN4 and QDSA short form. Finally, ropivacaine blood concentrations will be dosed by multiple blood samples taken over 24 hours after realizing the SPB, in order to make a population pharmacokinetic analysis, and evaluate the degree of ropivacaine resorption at this level.
Interventions
PROCEDURESerratus anterior plane block
SPB realized under ultrasound guidance. Infiltration of local anesthetic (bolus then infusion through a multi-holed catheter) is realized under the serratus anterior muscle at a level situated around the 5th to 6th intercostal space on the anterior axillary lign, in order to anesthetize the cutaneous lateral branches of the intercostal nerves, with a first ropivacaine 0,375% bolus (0,4ml/kg), followed by an infusion of ropivacaine 0,2% at a 10ml/hr rate, through a multi-holed catheter, for a duration of 24 hours.
DEVICEpatient-controlled analgesia
Each patient controls his analgesia with an IV bolus of 2mg of morphine every 10 minutes if needed, with a maximum of 20mg every 4 hours.
Sponsors
Université Libre de Bruxelles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Random attribution by computer
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
American Society of Anesthesiologists physic status 1, 2 and 3 who require surgical video-assisted thoracoscopy or video assisted thoracic surgery without mini-thoracotomy 1. Lung pathologies: * biopsies * symphysis, pleurectomy * emphysema bullae resection 2. pleural pathologies: * biopsies * collections, intra pleural effusion 3. mediastinal pathologies: * adenopathy staging * cysts * sympathectomy T2-T5 * vagotomy * splanchnicectomy
Exclusion criteria
1. refusal 2. allergy to local anesthetic - contra-indication to the use of ropivacaine 3. pregnancy 4. liver failure 5. severe kidney disease (GFR \< 15ml/min) 6. chronic intake of opioids 7. neurological or psychiatric disorders interfering with pain assessment 8. severe and morbid obesity (BMI \> 35)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine consumption (mg) | 24 hours | Consumption of intravenous morphine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | 24 hours | Visual Analog Score: assess pain on surgical site |
| Post operative nausea | 24 hours | Presence or absence of nausea |
| Post operative vomiting | 24hrs | Presence or absence of vomiting |
| Sensitivity of SPB zone | 24 hours | Cold (ether) applied on the skin of the operated hemithorax |
| Post operative chronic pain | 2 months | Two months after surgery: QDSA-sf (short form of Questionnaire de douleur de Saint-Antoine) |
Countries
Belgium
Contacts
Primary ContactPaul Gruson
Outcome results
None listed