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Chronic PainPhase 4NCT05175001

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

A Phase 4 study testing Diprospan and Ropivacaine in people with Chronic Pain, run by Affiliated Hospital of Nantong University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Pain
What is being tested?
Diprospan and Ropivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteChina
Study dates
1 May 2021to 30 Jan 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 -

Who cannot join

  • 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
Show all 11Show fewer
  • 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 -

Trial locations and contacts

1 site in 1 country.

Yibin Qin, Associate chief physician contact

13815212600

572537172@qq.com

Mengru Cui, Resident contact

18752115936

131947343@qq.com

China1 site, 1 recruiting

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226000

    Tao Zhang, Director of ethics Committee, 0513-85052390

    Recruiting

Other trials in China

About this study

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

Read the 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 .

Conditions
Chronic Pain
Being tested
Diprospan, Ropivacaine
Keywords
chronic pain, nerve block
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DiprospanDrug

    Also called Compound Betamethasone Injection

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

  • RopivacaineDrug

    Only ropivacaine in ultrasound-guided thoracic paravertebral nerve block

Study groups in NCT05175001
Study groupRoleWhat they receive
Group RPlacebo comparatorThe 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
Receives: Drug: Ropivacaine
Group RDExperimentalThe 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
Receives: Drug: Diprospan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute and chronic postoperative pain

    Numeric rating scale(NRS) is used to assess acute postoperative pain

    Measured: 24 hours after surgery

  2. Acute and chronic postoperative pain

    Numeric rating scale(NRS) is used to assess acute postoperative pain

    Measured: 48 hours after surgery

  3. Acute and chronic postoperative pain

    Numeric rating scale(NRS) is used to assess acute postoperative pain

    Measured: 72 hours after surgery

  4. Acute and chronic postoperative pain

    Numeric rating scale(NRS) is used to assess chronic postoperative pain

    Measured: 1 month after surgery

  5. Acute and chronic postoperative pain

    Numeric rating scale(NRS) is used to assess chronic postoperative pain

    Measured: 3 months after surgery

  6. Acute and chronic postoperative pain

    Numeric rating scale(NRS) is used to assess chronic postoperative pain

    Measured: 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2022
  2. Study start1 May 2021
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion30 Jan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05175001
Sponsor's protocol ID
AHNantongUniversity
Status last verified
Mar 2022
First submitted
7 Dec 2021
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 24472084

  • 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.

    PubMed 28394848

  • 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.

    PubMed 27716229

  • 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.

    PubMed 23121415

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Diprospan and Ropivacaine in people with Chronic Pain, run by Affiliated Hospital of Nantong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yibin Qin, Associate chief physician (13815212600, 572537172@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute and chronic postoperative pain (time frame: 24 hours after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05175001, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.

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