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CompletedNCT06684210EOIUpdated Nov 12, 2024

Study of the Clinical Effect of External Oblique Muscle Intercostal Muscle Plane Block in Abdominal Surgery

An interventional study of Intercostal plane block of the external oblique muscle in Nerve Block and Pain, sponsored by The First Hospital of Qinhuangdao. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-11-12.

Sponsored by The First Hospital of Qinhuangdao · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Mar 2023, registered Oct 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 244 studies in Pain with a site in China — 64 open to participants now, 70 under way, 2 of them phase 3. Pain · China.

Enrollment
154th of 209
60 · median 120
Started
2023
with 24 others
No phase
114 of 244
38 open now
Registered
174th of 244
by date

Among the 244 studies in Pain with a site in China, this one is the 154th largest by enrollment of the 209 interventional ones, is one of 25 that started in 2023, is one of 114 with no phase, and was the 174th registered.

By phase

244 studies; the count open now beside each. This study's row is marked.

No phasethis study114 · 38 open
Observational35 · 11 open
Phase 430 · 6 open
Phase 321 · 1 open
Phase 218 · 4 open
Phase 117 · 4 open
Phase 2/35 · 0 open
Phase 1/24 · 0 open

By the year they started

First in 1992; this study’s year is marked. 25 started in 2023.

Size and results

Median enrollment 120 across the 209 interventional studies, 169 across the 34 observational. Of the 121 that completed or were terminated, 17 (14%) have results posted.

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02

Study 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.

Read the detailed description

Approved by the hospital ethics committee, 60 patients undergoing thoracic and abdominal surgery were selected in this study. They were divided into experimental group (n=30) and control group (n=30). The experimental group was given 0.5% ropivacaine intercostal nerve block, 2.0ug/kg sufentanil and tropisetron 5mg intravenous analgesia, and the control group was given 2.0ug/kg sufentanil and tropisetron 5mg intravenous analgesia. MAP, HR and SPO2 were recorded at admission (T0), completion of induction (T1), skin incision (T2), 30min after operation (T3) and 30min after extubation (T5). The block range of nerve block in the experimental group was recorded. The VAS score and the number of patient-controlled analgesia pump were recorded 30min after extubation, 6h, 24h and 48h after operation in resting state and cough state. Postoperative adverse reactions such as respiratory depression, expectoration weakness, nausea, vomiting, and skin itching were recorded. The first time to get out of bed after operation was recorded.

03

Conditions studied

  • Nerve Block
  • Pain

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04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Coagulation disorders, Liver/kidney disease, Abdominal surgery history, Infection in the block application area, Chronic opioid use.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    External oblique intercostal plane block.

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

    Procedure: Intercostal plane block of the external oblique muscle

  • No intervention
    Patient controlled in travenousanalgesia.

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

Interventions

  • ProcedureIntercostal plane block of the external oblique muscle

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

06

What researchers measure

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

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

Secondary outcomes

  1. Changes in blood pressure

    Mean arterial pressure at different time points.Mean arterial pressure will be reported in mmHg.

    Time frame: Perioperative period

  2. Changes in heart rate

    Heart rate at different time points.Heart rate will be reported in counts per minute.

    Time frame: Perioperative period

  3. Extent of action of external oblique intercostal muscle plane block

    The specific extent of action of the external oblique muscle intercostal muscle plane block in the thoracoabdominal wall.

    Time frame: Ten minutes after the nerve block

07

Study locations

1 site
  • The first hospital of Qinhuangdao
    Qinhuangdao, Hebei 066000, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2023 to primary completion in Jan 2024, 10 months.

Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 10 months is close to that.

Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 17, 2024
First posted
Nov 12, 2024
StartActual
Mar 1, 2023
Primary completionActual
Jan 1, 2024
CompletionActual
Feb 1, 2024
Last update
Nov 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06684210
Lead sponsor
The First Hospital of Qinhuangdao
Responsible party
Sponsor
First posted
Nov 12, 2024
Start date
Mar 1, 2023
Primary completion
Jan 1, 2024
Completion
Feb 1, 2024
Last update
Nov 12, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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