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

Sponsor

Affiliated Hospital of Nantong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05175001

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Drug: Diprospan Drug: Ropivacaine	Phase 4

Detailed Description

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 .

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Investigator, Outcomes Assessor)

Masking Description:

None of the participants know which group they were in,neither of the investigators and outcomes assessor.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jan 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Group R 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 Only ropivacaine in ultrasound-guided thoracic paravertebral nerve block
Experimental: Group RD 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 Diprospan combined with ropivacaine in ultrasound-guided thoracic paravertebral nerve block Other Names: Compound Betamethasone Injection

Arm

Intervention/Treatment

Placebo Comparator: Group R

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

Only ropivacaine in ultrasound-guided thoracic paravertebral nerve block

Experimental: Group RD

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

Diprospan combined with ropivacaine in ultrasound-guided thoracic paravertebral nerve block

Other Names:

Compound Betamethasone Injection

Outcome Measures

Primary Outcome Measures

Acute and chronic postoperative pain [24 hours after surgery]
Numeric rating scale(NRS) is used to assess acute postoperative pain
Acute and chronic postoperative pain [48 hours after surgery]
Numeric rating scale(NRS) is used to assess acute postoperative pain
Acute and chronic postoperative pain [72 hours after surgery]
Numeric rating scale(NRS) is used to assess acute postoperative pain
Acute and chronic postoperative pain [1 month after surgery]
Numeric rating scale(NRS) is used to assess chronic postoperative pain
Acute and chronic postoperative pain [3 months after surgery]
Numeric rating scale(NRS) is used to assess chronic postoperative pain
Acute and chronic postoperative pain [6 months after surgery]
Numeric rating scale(NRS) is used to assess chronic postoperative pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 -