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

September 26, 2022 updated by: Yibin Qin, Affiliated Hospital of Nantong University

Efficacy of Compound Betamethasone Injection Combined With Ropivacaine in Ultrasound-guided Slit Intercostals Nerve Block for Chronic Post-thoracotomy Pain:A Single Blind Randomized Control Trial

The patients were divided into two groups by random number method: GroupRD1 group and GroupRD2 group were given general anesthesia and intercostal nerve block.The drug for intercostal nerve block was 0.33% ropivacaine +2.333mg compound betamethasone (1.667mg betamethasone dipropionate + 0.667mg betamethasone sodium phosphate) to 15ml.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The RD1 group received ultrasound-guided intercostal nerve block at the incision before anesthesia induction, and the RD2 group received ultrasound-guided intercostal nerve block at the lateral costal Angle before anesthesia induction.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nantong, Jiangsu, China, 226001
        • Recruiting
        • YiBinQin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18-70 years old
  2. ASA grade I-III
  3. BMI: 18.5-28kg/m2
  4. Type of surgery: elective thoracoscopic lung mass resection
  5. Informed consent has been signed by the patient and/or family members

Exclusion Criteria:

  1. game anesthesia or sugar cortical hormone drugs allergic
  2. preoperative use of opioid medicines
  3. serious blood coagulation dysfunction
  4. serious heart, lung, liver and renal insufficiency
  5. put, chemotherapy, and glucocorticoid immunosuppressive therapy history or diseases of the immune system
  6. peptic ulcer
  7. newly gastrointestinal surgery
  8. has a history of thoracic surgery
  9. is the central nervous system disease
  10. Other glucocorticoids should be used with caution in patients such as fractures, wound repair, corneal ulcers, hyperadrenocortical disease, diabetes mellitus, pregnant women, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intercostal nerve block at the incision
General anesthesia and intercostal nerve block were performed.The drug for intercostal nerve block was 0.33% ropivacaine +2.333mg compound betamethasone (1.667mg betamethasone dipropionate + 0.667mg betamethasone sodium phosphate) to 15ml
Other: intercostal nerve block
General anesthesia and intercostal nerve block were performed. The drug for intercostal nerve block was 0.33% ropivacaine +2.333mg compound betamethasone (1.667mg betamethasone dipropionate + 0.667mg betamethasone sodium phosphate) to 15ml
Drug: ropivacaine + compound betamethasone
The drug for intercostal nerve block was 0.33% ropivacaine +2.333mg compound betamethasone (1.667mg betamethasone dipropionate + 0.667mg betamethasone sodium phosphate) to 15ml
Active Comparator: lateral intercostal nerve block at costal angle
General anesthesia and intercostal nerve block were performed.The drug for intercostal nerve block was 0.33% ropivacaine +2.333mg compound betamethasone (1.667mg betamethasone dipropionate + 0.667mg betamethasone sodium phosphate) to 15ml
Drug: ropivacaine + compound betamethasone
The drug for intercostal nerve block was 0.33% ropivacaine +2.333mg compound betamethasone (1.667mg betamethasone dipropionate + 0.667mg betamethasone sodium phosphate) to 15ml
Other: lateral intercostal nerve block
lateral intercostal nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute and chronic postoperative pain
Time Frame: 6 hours after surgery
Numeric rating scale(NRS) is used to assess acute postoperative pain
6 hours after surgery
Acute and chronic postoperative pain
Time Frame: 24 hours after surgery
Numeric rating scale(NRS) is used to assess acute postoperative pain
24 hours after surgery
Acute and chronic postoperative pain
Time Frame: 48 hours after surgery
Numeric rating scale(NRS) is used to assess acute postoperative pain
48 hours after surgery
Acute and chronic postoperative pain
Time Frame: 1 months after surgery
Numeric rating scale(NRS) is used to assess acute postoperative pain
1 months after surgery
Acute and chronic postoperative pain
Time Frame: 3 months after surgery
Numeric rating scale(NRS) is used to assess acute postoperative pain
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Nantong University

Investigators

  • Study Director: DingYing Ge, Affiliated Hospital of Nantong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2022

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

September 19, 2022

First Submitted That Met QC Criteria

September 26, 2022

First Posted (Actual)

September 27, 2022

Study Record Updates

Last Update Posted (Actual)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-K107-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nerve Block

Clinical Trials on intercostal nerve block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe