NCT05556122

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

September 19, 2022

Last Update Submit

September 26, 2022

Conditions

Nerve Block

Outcome Measures

Primary Outcomes (5)

  • Acute and chronic postoperative pain

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

    6 hours after surgery

  • 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

    1 months after surgery

  • Acute and chronic postoperative pain

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

    3 months after surgery

Study Arms (2)

intercostal nerve block at the incision

EXPERIMENTAL

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 blockDrug: ropivacaine + compound betamethasone

lateral intercostal nerve block at costal angle

ACTIVE COMPARATOR

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: lateral intercostal nerve blockDrug: ropivacaine + compound betamethasone

Interventions

intercostal nerve blockOTHER

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

intercostal nerve block at the incision
lateral intercostal nerve blockOTHER

lateral intercostal nerve block

lateral intercostal nerve block at costal angle
ropivacaine + compound betamethasoneDRUG

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

intercostal nerve block at the incisionlateral intercostal nerve block at costal angle

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • ASA grade I-III
  • BMI: 18.5-28kg/m2
  • Type of surgery: elective thoracoscopic lung mass resection
  • Informed consent has been signed by the patient and/or family members

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

YiBinQin

Nantong, Jiangsu, 226001, China

RECRUITING

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • DingYing Ge

    Affiliated Hospital of Nantong University

    STUDY DIRECTOR

Central Study Contacts

YiBin Qin

CONTACT

13815212600572537172@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

September 19, 2022

First Posted

September 27, 2022

Study Start

July 4, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

September 27, 2022

Record last verified: 2022-09

Locations

CN(1)