NCT06684210

Brief Summary

This study intends to apply external oblique intercostal muscle plane block in thoracoabdominal resection, and to explore its effect on perioperative analgesia and rehabilitation quality in patients undergoing thoracoabdominal surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

10 months

First QC Date

October 17, 2024

Last Update Submit

November 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient's postoperative pain score

    Using the VIsual Analogue Scale,patients were guided to indicate the corresponding pain score according to their own pain situation, and the score ranged from 0 to 10. To evaluate the degree of postoperative pain, a score of 0 indicates no pain at all, a score of 2 indicates mild pain, and a score of 10 indicates the most severe pain, with higher scores indicating more severe pain

    Extubation for 30minutes, 6 hours after surgery, 24 hours after surgery, and 48 hours after surgery

Secondary Outcomes (3)

  • Changes in blood pressure

    Perioperative period

  • Changes in heart rate

    Perioperative period

  • Extent of action of external oblique intercostal muscle plane block

    Ten minutes after the nerve block

Study Arms (2)

External oblique intercostal plane block.

EXPERIMENTAL

Given 0.5% ropivacaine intercostal nerve block, 2.0ug/kg sufentanil + tropisetron 5mg intravenous analgesia.

Procedure: Intercostal plane block of the external oblique muscle

Patient controlled in travenousanalgesia.

NO INTERVENTION

Given intravenous analgesia with 2.0ug/kg sufentanil + tropisetron 5 mg.

Interventions

Under ultrasound guidance, a single dose of 0.25% ropivacaine 20ml was given for bilateral intercostal muscle plane block of external oblique muscles

External oblique intercostal plane block.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA Physical Status Classification of I-II Aged 18-60 years old ; Will be scheduled to undergo elective LC

You may not qualify if:

  • Coagulation disorders, Liver/kidney disease, Abdominal surgery history, Infection in the block application area, Chronic opioid use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first hospital of Qinhuangdao

Qinhuangdao, Hebei, 066000, China

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2024

First Posted

November 12, 2024

Study Start

March 1, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

November 12, 2024

Record last verified: 2024-11

Locations