Serratus Plain Block Versus Paravertebral Block Versus Serratus Plain Block and Paravertebral Block for Postoperative Pain Following Thoracoscopic Surgery

Study Overview
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Brief Summary
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Acute and chronic postoperative pain remains a major concern following thoracoscopic surgery. Firstly because pain constitutes a serious concern for patients after surgery, and secondarily because an ineffective control of pain may lead to postoperative morbidity, especially in lung cancer surgery. To date, several procedures have been described but the best modality of locoregional analgesia for thoracoscopic surgery has not been assessed yet. The main objective of this study is to evaluate efficiency of several validated approaches for preoperative locoregional analgesia, comparing serratus plain block versus paravertebral block versus serratus plain block and paravertebral block for postoperative pain following thoracoscopic surgery. To this end, the investigators will conduct an interventional prospective monocentric, double blind, compared and randomized study. Previously to thoracoscopic surgery, patients will be randomized in one of the three following arms: serratus plain block, paravertebral block or serratus plain block and paravertebral block combined.

Official Title
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Serratus Plain Block Versus Paravertebral Block Versus Serratus Plain Block and Paravertebral Block for Postoperative Pain Following Thoracoscopic Surgery

Conditions
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Anesthesia, Local, Pain, Postoperative

Intervention / Treatment
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* Drug: loco-regional anesthesia serratus plane bloc (Ropivacaine 2 mg/mL, 40 mL) and paravertebral placebo bloc (saline, 20 mL)
* Drug: Loco-regional anesthesia : paravertebral bloc (Ropivacaine 4 mg/mL, 20 mL) and serratus plane placebo bloc (saline, 40 mL)
* Drug: Loco-regional anesthesia : serratus plane bloc (Ropivacaine 1,3 mg/mL, 40 mL) and paravertebral bloc (Ropivacaine 1,3 mg/mL, 20 mL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patient over18 years old without guardianship video-assisted thoracoscopic surgery with 3 trocars No cons-indications to loco-regional anesthesia (allergy, skin condition) Exclusion Criteria: patient under 18 years old patient under guardianship pregnant rejection of consent rejection of loco-regional anesthesia chronic pain antecedents under morphine medication pain assessment impossible

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: serratus loco-regional anesthesia<br>patient who underwent thoracoscopic surgery will be assigned to serratus plane bloc (Ropivacaine 2 mg/mL, 40 mL) and paravertebral placebo bloc (saline, 20 mL) | Drug: loco-regional anesthesia serratus plane bloc (Ropivacaine 2 mg/mL, 40 mL) and paravertebral placebo bloc (saline, 20 mL)<br>* Each patient who underwent thoracoscopic surgery will be assigned to one procedure of Loco-regional anesthesia<br>|
| Experimental: paravertebral bloc Loco-regional anesthesia<br>patient who underwent thoracoscopic surgery will be assigned to paravertebral bloc (Ropivacaine 4 mg/mL, 20 mL) and serratus plane placebo bloc (saline, 40 mL) | Drug: Loco-regional anesthesia : paravertebral bloc (Ropivacaine 4 mg/mL, 20 mL) and serratus plane placebo bloc (saline, 40 mL)<br>* Each patient who underwent thoracoscopic surgery will be assigned to one procedure of Loco-regional anesthesia.<br>|
| Experimental: serratus and paravertebral bloc Loco-regional anesthesia<br>patient who underwent thoracoscopic surgery will be assigned to serratus plane bloc (Ropivacaine 1,3 mg/mL, 40 mL) and paravertebral bloc (Ropivacaine 1,3 mg/mL, 20 mL) | Drug: Loco-regional anesthesia : serratus plane bloc (Ropivacaine 1,3 mg/mL, 40 mL) and paravertebral bloc (Ropivacaine 1,3 mg/mL, 20 mL)<br>* Each patient who underwent thoracoscopic surgery will be assigned to one procedure of Loco-regional anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Visual analog scale (VAS) score at coughing | Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain. Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale. With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable). | Immediately after following thoracoscopic surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Visual analog scale (VAS) score at coughing | Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain. Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale. With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable). | H1 = one hour following thoracoscopic surgery | 
| Pain Visual analog scale (VAS) score at coughing | Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain. Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale. With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable). | H3 = 3 hours following thoracoscopic surgery | 
| Pain Visual analog scale (VAS) score at coughing | Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain. Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale. With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable). | H6 = 6 hours following thoracoscopic surgery | 
| Pain Visual analog scale (VAS) score at coughing | Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain. Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale. With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable). | Day1 = one day following thoracoscopic surgery | 
| Pain Visual analog scale (VAS) score at coughing | Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain. Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale. With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable). | Day2 = two days following thoracoscopic surgery | 
| Pain Visual analog scale (VAS) score at coughing | Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions. The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain. Numerical rating scales are similar to analogue scales except that numbers (e.g., 0 to 5) are entered along the scale. With category scales, the patient is asked to circle the word that best describes his or her condition (e.g., for pain intensity: None, Moderate, Severe, Unbearable). | Day3 = 3 days following thoracoscopic surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Postoperative, Anesthesia, Local