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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: Ropivacaine; Drug: Diprospan

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yibin Qin, Associate chief physician; Phone Number: 13815212600; Email: 572537172@qq.com
• Study Contact Backup: Name: Mengru Cui, Resident; Phone Number: 18752115936; Email: 131947343@qq.com

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226000
      • Recruiting
      • Affiliated Hospital of Nantong University
      • Contact: Tao Zhang, Director of ethics Committee; Phone Number: 0513-85052390

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University
• Investigators: Study Director: Yibin Qin, Associate chief physician, Affiliated Hospital of Nantong University

Publications and helpful links

General Publications

• 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.
• 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.
• 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 Oct 4;16(1):84. doi: 10.1186/s12871-016-0251-9.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): January 30, 2023

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 30, 2021
• First Posted (Actual): January 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: chronic pain; nerve block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anesthetics, Local; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Ropivacaine; Betamethasone dipropionate, betamethasone sodium phosphate drug combination
• Other Study ID Numbers: AHNantongUniversity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No