search
Back to results

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

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Diprospan
Ropivacaine
Sponsored by
Affiliated Hospital of Nantong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Pain focused on measuring chronic pain, nerve block

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Affiliated Hospital of Nantong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Group R

Group RD

Arm 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.A 30-mL bolus of a solution of 0.33% ropivacaine in saline was administered under real-time ultrasound monitoring

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 7, 2021
Last Updated
March 1, 2022
Sponsor
Affiliated Hospital of Nantong University
search

1. Study Identification

Unique Protocol Identification Number
NCT05175001
Brief Title
Efficacy of Compound Betamethasone Injection Combined With Ropivacaine in Ultrasound-guided Thoracic Paravertebral Nerve Block for Chronic Post-thoracotomy Pain
Official Title
Efficacy of Compound Betamethasone Injection Combined With Ropivacaine in Ultrasound-guided Thoracic Paravertebral Nerve Block for Chronic Post-thoracotomy Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Nantong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, nerve block

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
None of the participants know which group they were in,neither of the investigators and outcomes assessor.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group R
Arm Type
Placebo Comparator
Arm 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.A 30-mL bolus of a solution of 0.33% ropivacaine in saline was administered under real-time ultrasound monitoring
Arm Title
Group RD
Arm Type
Experimental
Arm 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.A 30-mL bolus of a solution of 0.33% ropivacaine plus 4.67mg Diprospan in saline was administered under real-time ultrasound monitoring
Intervention Type
Drug
Intervention Name(s)
Diprospan
Other Intervention Name(s)
Compound Betamethasone Injection
Intervention Description
Diprospan combined with ropivacaine in ultrasound-guided thoracic paravertebral nerve block
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Only ropivacaine in ultrasound-guided thoracic paravertebral nerve block
Primary Outcome Measure Information:
Title
Acute and chronic postoperative pain
Description
Numeric rating scale(NRS) is used to assess acute postoperative pain
Time Frame
24 hours after surgery
Title
Acute and chronic postoperative pain
Description
Numeric rating scale(NRS) is used to assess acute postoperative pain
Time Frame
48 hours after surgery
Title
Acute and chronic postoperative pain
Description
Numeric rating scale(NRS) is used to assess acute postoperative pain
Time Frame
72 hours after surgery
Title
Acute and chronic postoperative pain
Description
Numeric rating scale(NRS) is used to assess chronic postoperative pain
Time Frame
1 month after surgery
Title
Acute and chronic postoperative pain
Description
Numeric rating scale(NRS) is used to assess chronic postoperative pain
Time Frame
3 months after surgery
Title
Acute and chronic postoperative pain
Description
Numeric rating scale(NRS) is used to assess chronic postoperative pain
Time Frame
6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 - Exclusion Criteria: 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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yibin Qin, Associate chief physician
Phone
13815212600
Email
572537172@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mengru Cui, Resident
Phone
18752115936
Email
131947343@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yibin Qin, Associate chief physician
Organizational Affiliation
Affiliated Hospital of Nantong University
Official's Role
Study Director
Facility Information:
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Zhang, Director of ethics Committee
Phone
0513-85052390

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24472084
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.
Results Reference
result
PubMed Identifier
28394848
Citation
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.
Results Reference
result
PubMed Identifier
27716229
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 Oct 4;16(1):84. doi: 10.1186/s12871-016-0251-9.
Results Reference
result
PubMed Identifier
23121415
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs