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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05175001
• Other study ID #: AHNantongUniversity
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2021
• Est. completion date: January 30, 2023

Study information

• Verified date: March 2022
• Source: Affiliated Hospital of Nantong University
• Contact: Yibin Qin, Associate chief physician
• Phone: 13815212600
• Email: 572537172[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Aged 18-70 years

2. American Society of Anesthesiologists(ASA) physical status of I-III

3. BMI: 18.5-28 kg/m2

4. Type of operation: elective thoracoscopic lobectomy

5. The patient and/or family members have signed the informed consent -

Exclusion Criteria:

1. Allergic to local anesthetics or glucocorticoids

2. Preoperative use of opioids

3. Severe coagulation dysfunction

4. Severe heart, lung, liver and kidney insufficiency

5. Used to have immunosuppressive therapies such as radiotherapy, chemotherapy and glucocorticoid, or have immune system diseases

6. Peptic ulcer

7. Perform astrointestinal anastomosis recently

8. Used to have a chest surgery

9. Central nervous system disease or peripheral neuropathy

10. Perioperative blood transfusion

11. Others: such as fracture, wound repair, corneal ulcer, adrenal hypercortical disease, diabetes, pregnant women -

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Diprospan
Diprospan combined with ropivacaine in ultrasound-guided thoracic paravertebral nerve block
• Ropivacaine
Only ropivacaine in ultrasound-guided thoracic paravertebral nerve block

Locations

Country	Name	City	State
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

References & Publications (4)

Marty P, Bennis M, Legaillard B, Cavaignac E, Ferre F, Lebon J, Brouchet A, Minville V. A New Step Toward Evidence of In Vivo Perineural Dexamethasone Safety: An Animal Study. Reg Anesth Pain Med. 2018 Feb;43(2):180-185. doi: 10.1097/AAP.0000000000000392. — View Citation

Wang QS, Jiang YH, Wang TD, Xiao T, Wang JK. Effects of betamethasone on neuropathic pain in a rat spare nerve injury model. Clin Exp Pharmacol Physiol. 2013 Jan;40(1):22-7. doi: 10.1111/1440-1681.12027. — View Citation

Watanabe K, Tokumine J, Yorozu T, Moriyama K, Sakamoto H, Inoue T. Particulate-steroid betamethasone added to ropivacaine in interscalene brachial plexus block for arthroscopic rotator cuff repair improves postoperative analgesia. BMC Anesthesiol. 2016 Oc — View Citation

Zhang YK, Yang H, Zhang JY, Song LJ, Fan YC. Comparison of intramuscular compound betamethasone and oral diclofenac sodium in the treatment of acute attacks of gout. Int J Clin Pract. 2014 May;68(5):633-8. doi: 10.1111/ijcp.12359. Epub 2014 Jan 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute and chronic postoperative pain	Numeric rating scale(NRS) is used to assess acute postoperative pain	24 hours after surgery
Primary	Acute and chronic postoperative pain	Numeric rating scale(NRS) is used to assess acute postoperative pain	48 hours after surgery
Primary	Acute and chronic postoperative pain	Numeric rating scale(NRS) is used to assess acute postoperative pain	72 hours after surgery
Primary	Acute and chronic postoperative pain	Numeric rating scale(NRS) is used to assess chronic postoperative pain	1 month after surgery
Primary	Acute and chronic postoperative pain	Numeric rating scale(NRS) is used to assess chronic postoperative pain	3 months after surgery
Primary	Acute and chronic postoperative pain	Numeric rating scale(NRS) is used to assess chronic postoperative pain	6 months after surgery