Ultrasound-guided Thoracic Paravertebral Block Using Ropivacaine With/Without Dexamethasone in Elective Thoracotomy

Study Overview
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Brief Summary
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The procedures of thoracotomy are among the most painful operations. In addition to post-thoracotomy pain, the outcomes of surgery are affected adversely by postoperative discomfort. Therefore, post-thoracotomy pain control can improve the satisfaction of patient and prevent postoperative complications such as pneumonia, atelectasis, or respiratory failure. Thoracic epidural analgesia (TEA) used to be widely considered as a standard technique for providing analgesia after a thoracotomy. However, TEA carries side-effects such as incomplete or failed block, epidural hematoma, abscess, hypotension, respiratory depression, or bradycardia, etc. Recently, thoracic paravertebral block (TPVB) is an alternative technique for TEA that may offer a comparable analgesic effect and a better side -effect profile for post-thoracotomy analgesia. When local anesthetic agents are used as single injection, they can provide analgesia for limited period. Various adjuvants have been tried in the past in order to enhance the duration and quality of postoperative analgesia. Previous studies with perineural dexamethasone demonstrated that it enhanced the duration of local anesthetic block. The mechanism of its action is blocking the nociceptive impulse transmission along the myelinated C fibers. Patient-controlled analgesia (PCA) devices have been shown to provide superior analgesia and greater patient satisfaction compared with intermittent administration. System of wire-less PCA provides remote monitoring, information management and PCA devices with high precision. The purpose of this research is to determine whether dexamethasone might prolong the duration of analgesia and improve the short-time outcomes when administered for TPVB along with local anesthetic agents in elective thoracotomy.

Official Title
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Study of Ultrasound-guided Thoracic Paravertebral Block Using Ropivacaine With/Without Dexamethasone in Elective Thoracotomy

Conditions
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Surgery

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Dexamethasone
* Other: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient American Society of Anesthesiologists（ASA） I III undergoing elective thoracotomy written informed consent from the patient or the relatives of the participating patient Exclusion Criteria: mental illness thoracic paravertebral blocks contraindicated local anesthetic allergy people who have heart disease people who have severe liver or renal disease people who have severe endocrine disease people who can't communicate effectively because of hearing or visual disorders

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Group C（Control）<br>Group C received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.9% saline 20ml combined with general anesthesia and intravenous patient controlled analgesia pump. | Other: saline<br>* ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.9% saline 20ml<br>* Other names: normal saline;|
| Experimental: Group R(Ropivacaine)<br>Group R received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20 ml combined with general anesthesia and intravenous patient controlled analgesia pump. | Drug: Ropivacaine<br>* ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml<br>* Other names: ropivacaine hydrochloride;|
| Experimental: Group D(Dexamethasone)<br>Group D received ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml and dexamethasone 5 mg combined with general anesthesia and intravenous patient controlled analgesia pump. | Drug: Ropivacaine<br>* ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml<br>* Other names: ropivacaine hydrochloride;Drug: Dexamethasone<br>* ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml and dexamethasone 5 mg<br>* Other names: dex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of visual analogue scale(VAS) of patients with different treatment-related events in the following 3 days after thoracotomy | to show the grading of pain in different groups after surgery | 6 hours,12hours,24hours and 72hours after operation | 
| the reality pressing number of patient controlled analgesia(PCA) of patients with different treatment-related events in the following 3 days after surgery | to show the consumption of analgesics after surgery | 6hours,12hours,24hours and 72hours after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic index | To show the changing trend of hemodynamics with different treatment-related events when receiving thoracotomy. | 24 hours after anesthesia | 
| The time of recovery | to show the quality of recovery | 24 hours after surgery | 
| The time of extubation | to show the quality of recovery | 24 hours after surgery | 
| the incidence of side effects | To compare the incidence rates of side effects, such as nausea, vomiting, dizziness, hypotension and bradyarrhythmia in the first 3 days after operation. | 3days after operation | 
| The complication after surgery | To compare the incidence rates of complications, such as pneumonia, atelectasis, respiratory failure, heart failure, etc | 30 days after surgery | 
| The first day of leaving bed after surgery |  | 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paravertebral block, patient controlled analgesia, ropivacaine, dexamethasone