Efficacy of Compound Betamethasone Injection Combined With Ropivacaine in Ultrasound-guided Thoracic Paravertebral Nerve Block for Chronic Post-thoracotomy Pain

Study Overview
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Brief Summary
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Chronic post-thoracotomy pain（CPTP）will not only have a negative impact on patients' physiology and psychology, but also affect postoperative recovery.A number of researches have demonstrated that Injury to the intercostal nerve during surgery predominantly accounts for the onset of CPTP.It is closely related to postoperative local acute inflammation and neuroinflammation. Thoracic paravertebral block (TPVB)has become a new trend for post-thoracotomy pain management.Glucocorticoids,as a adjuvant, are reported to prolong the effects of local anesthetic for peripheral nerve blocks.Diprospan is a long-acting glucocorticoid. It has been widely used in clinical treatment of various pain syndromes for powerful analgesic and anti-inflammatory effects. At present, most clinical reports are limited to the acute postoperative period, and there are few studies focusing on the long-term postoperative analgesic effect of diprospan.Therefore, it is reasonable for us to hypothesise diprospan, as a longer-acting glucocorticoid, can provide more lasting analgesic effects,or even reduce the incidence of CPTP

Detailed Description
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PARAVERTEBRAL BLOCK (PVB) involves the injection of local anesthetic (LA) into a wedge-shaped space lateral to the spinal nerves as they emerge from the intervertebral foramina, producing ipsilateral somatosensory and sympathetic nerve blockade.Since its initial application in abdominal surgery, the technique has been adapted for rib fracture, flflail chest, open cholecystectomy, hepatic-biliary surgery, outpatient inguinal hernia repair, major breast cancer surgery, and open thoracotomy patient populations.Based on several recent systematic reviews and metaanalyses,TPVB and TEA are equal in analgesic effect after thoracic surgery. Moreover, TPVB is associated with fewer side effects,such as urinary retention,nausea/vomiting,pruritus and hypotension. It can also be used for patients with coagulation disorders. Kang et al. argued that TPVB can significantly improve postoperative rehabilitation in patients undergoing thoracoscopic radical lung cancer surgery .

Official Title
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Efficacy of Compound Betamethasone Injection Combined With Ropivacaine in Ultrasound-guided Thoracic Paravertebral Nerve Block for Chronic Post-thoracotomy Pain

Conditions
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Chronic Pain

Intervention / Treatment
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* Drug: Diprospan
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-70 years American Society of Anesthesiologists(ASA) physical status of I-III BMI: 18.5-28 kg/m2 Type of operation: elective thoracoscopic lobectomy The patient and/or family members have signed the informed consent - Exclusion Criteria: Allergic to local anesthetics or glucocorticoids Preoperative use of opioids Severe coagulation dysfunction Severe heart, lung, liver and kidney insufficiency Used to have immunosuppressive therapies such as radiotherapy, chemotherapy and glucocorticoid, or have immune system diseases Peptic ulcer Perform astrointestinal anastomosis recently Used to have a chest surgery Central nervous system disease or peripheral neuropathy Perioperative blood transfusion Others: such as fracture, wound repair, corneal ulcer, adrenal hypercortical disease, diabetes, pregnant women -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patient is placed in lateral decubitus position with the operative side facing up, and the thoracic paravertebral nerve block will be performed under ultrasound. We select T4-5,T6-7and T8-9 intervertebral spaces for puncture.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group R<br>The patient is placed in lateral decubitus position with the operative side facing up, and the thoracic paravertebral nerve block will be performed under ultrasound. We select T4-5,T6-7and T8-9 intervertebral spaces for puncture.A 30-mL bolus of a solution of 0.33% ropivacaine in saline was administered under real-time ultrasound monitoring | Drug: Ropivacaine<br>* Only ropivacaine in ultrasound-guided thoracic paravertebral nerve block<br>|
| Experimental: Group RD<br>The patient is placed in lateral decubitus position with the operative side facing up, and the thoracic paravertebral nerve block will be performed under ultrasound. We select T4-5,T6-7and T8-9 intervertebral spaces for puncture.A 30-mL bolus of a solution of 0.33% ropivacaine plus 4.67mg Diprospan in saline was administered under real-time ultrasound monitoring | Drug: Diprospan<br>* Diprospan combined with ropivacaine in ultrasound-guided thoracic paravertebral nerve block<br>* Other names: Compound Betamethasone Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute and chronic postoperative pain | Numeric rating scale(NRS) is used to assess acute postoperative pain | 24 hours after surgery | 
| Acute and chronic postoperative pain | Numeric rating scale(NRS) is used to assess acute postoperative pain | 48 hours after surgery | 
| Acute and chronic postoperative pain | Numeric rating scale(NRS) is used to assess acute postoperative pain | 72 hours after surgery | 
| Acute and chronic postoperative pain | Numeric rating scale(NRS) is used to assess chronic postoperative pain | 1 month after surgery | 
| Acute and chronic postoperative pain | Numeric rating scale(NRS) is used to assess chronic postoperative pain | 3 months after surgery | 
| Acute and chronic postoperative pain | Numeric rating scale(NRS) is used to assess chronic postoperative pain | 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, nerve block