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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05175001
Enrollment
100
Registered
2022-01-03
Start date
2021-05-01
Completion date
2023-01-30
Last updated
2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

chronic pain, nerve block

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

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 .

Interventions

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

DRUGRopivacaine

Only ropivacaine in ultrasound-guided thoracic paravertebral nerve block

Sponsors

Affiliated Hospital of Nantong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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 -

Design outcomes

Primary

MeasureTime frameDescription
Acute and chronic postoperative pain24 hours after surgeryNumeric rating scale(NRS) is used to assess acute postoperative pain

Countries

China

Contacts

Primary ContactYibin Qin, Associate chief physician
572537172@qq.com13815212600
Backup ContactMengru Cui, Resident
131947343@qq.com18752115936

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026