Serratus Anterior Plane Block: Post-operative Analgesia in Video-assisted Thoracic Surgery

Not Applicable

• Conditions: Post-operative Pain; Serratus Anterior Plane Block; Post-operative Chronic Pain; Regional Anesthesia; Thoracic Surgery; Pharmacokinetic Analysis
• Interventions: Device: patient-controlled analgesia; Procedure: Serratus anterior plane block

• Registration Number: NCT03277391
• Lead Sponsor: Université Libre de Bruxelles

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.

Study Timeline

• Study Start: 2017-04-14
• Study First Submitted: 2017-08-25
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-06
• Last Update Submitted: 2017-09-06
• Study First Posted: 2017-09-11
• Last Update Posted: 2017-09-11
• Primary Completion: 2018-04
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patient-controlled analgesia	patient-controlled analgesia	patient-controlled analgesia: pump containing morphine (1mg/ml) and dehydrobenzperidol (50 mcg/ml).
Serratus anterior plane block	patient-controlled analgesia	Deep serratus anterior plane block
Serratus anterior plane block	Serratus anterior plane block	Deep serratus anterior plane block

Primary Outcome Measures

Name	Time	Method
Morphine consumption (mg)	24 hours	Consumption of intravenous morphine

Secondary Outcome Measures

Name	Time	Method
Post operative chronic pain	2 months	Two months after surgery: DN4 questionnaire
Pain score	24 hours	Visual Analog Score: assess pain on surgical site
Sensitivity of SPB zone	24 hours	Cold (ether) applied on the skin of the operated hemithorax
Post operative vomiting	24hrs	Presence or absence of vomiting
Post operative nausea	24 hours	Presence or absence of nausea

Trial Locations

Locations (1)

Hopital Erasme; 🇧🇪 Anderlecht, Bruxelles, Belgium