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

NCT05175001 | Unknown Phase 4

• 1 other identifier: AHNantongUniversity
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Pain

Keywords

chronic pain; nerve block

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Group R

PLACEBO COMPARATOR

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

Group RD

EXPERIMENTAL

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

Interventions

Diprospan DRUG

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

Also known as: Compound Betamethasone Injection

Group RD

Ropivacaine DRUG

Only ropivacaine in ultrasound-guided thoracic paravertebral nerve block

Group R

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226000, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 24472084 RESULT

• 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.

  PMID: 28394848 RESULT

• 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.

  PMID: 27716229 RESULT

• 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.

  PMID: 23121415 RESULT

MeSH Terms

Conditions

Chronic Pain

Interventions

betamethasone dipropionate, betamethasone sodium phosphate drug combination; Ropivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Yibin Qin, Associate chief physician

  Affiliated Hospital of Nantong University

  STUDY DIRECTOR

Central Study Contacts

Yibin Qin, Associate chief physician

CONTACT

13815212600; 572537172@qq.com

Mengru Cui, Resident

CONTACT

18752115936; 131947343@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: None of the participants know which group they were in,neither of the investigators and outcomes assessor.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Model Details: 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.

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 3, 2022
• Study Start: May 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: January 30, 2023
• Last Updated: March 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)