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Gastrointestinal DiseaseNCT04934904

The Treatment of Acute Gastrointestinal Injury Via Ultrasound-guided Erector Spinae Plane Block

A study testing Ropivacaine injection in people with Gastrointestinal Disease, run by Zhujiang Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this single-center, randomized, parallel control clinical trial, patients will be randomly assigned to two groups. The treatment group receives ultrasound-guided erector spinae plane block with routine treatment of Acute Gastrointestinal Injury (AGI) for 7 days or until transferred to the general ward, while the… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Gastrointestinal Disease
What is being tested?
Ropivacaine injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
1 Aug 2019to 15 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • AGI are diagnosed according to the diagnostic criteria proposed by European Society Intensive Care Medicine (ESICM) in 2012 and the AGI grade great than or equal to II.
  • Age 18-80 years.
  • Expected length of stay longer than 3 days.

Who cannot join

  • Mean arterial pressure is still less than 65 millimeter of Mercury (mmHg) treated with rehydration and vasoactive agents, or with the dosage of norepinephrine more than 0.5ug/kg/min.
  • Heart rates are less than 50 beats per minute or moderate and severe atrioventricular block without pacemaker.
  • Primary gastrointestinal disease such as mechanical intestinal obstruction, massive hemorrhage of gastrointestinal tract and gastrointestinal perforation.
  • Severe trauma of chest, abdomen or back. gastrointestinal tract surgery history.
  • Neuromuscular disorders.
  • Drug addiction, alcohol abuse, opioid or amphetamine dependence, or mental disorders.
Show all 13Show fewer
  • Pregnancy.
  • Brain dead.
  • Malignant tumor, or end-stage cachexia.
  • With contraindications of the erector spinae plane block (ESPB), such as local infection, Spinal diseases or immobilization.
  • Allergy to local anesthetics.
  • Significant abnormalities in blood coagulation parameters.
  • Without written informed consent.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

Other trials in China

About this study

Official title: The Treatment of Acute Gastrointestinal Injury Via Ultrasound-guided Erector Spinae Plane Block - a Prospective, Single-center, Randomized, Controlled Trial

In this single-center, randomized, parallel control clinical trial, patients will be randomly assigned to two groups. The treatment group receives ultrasound-guided erector spinae plane block with routine treatment of Acute Gastrointestinal Injury (AGI) for 7 days or until transferred to the general ward, while the control group only receives routine treatment of AGI. The primary outcome is the cure and remission rate of AGI.

Read the detailed description

Detailed Description:

Study title: The treatment of Acute Gastrointestinal Injury via ultrasound-guided erector spinae plane block - a prospective, single-center, randomized, controlled trial

Principal Investigator: Professor Wang Hua, Department of Critical Care Unit, Zhujiang Hospital of Southern Medical University

Study subjects: Patients age from 18 to 80 with AGI Ⅱ or greater

Study phase: Investigator Initiated Trial(IIT)

Primary objectives:

To evaluate whether ultrasound-guided erector spinae plane block can reduce the grade of AGI , and improve the cure and remission rate of AGI.

Experimental Group:

On the basis of routine clinical treatment, the ultrasound-guided erector spinae plane block intervention is given. On the first day enrolled, patients are performed with ultrasound-guided erector spinae plane block and cannula will be placed on T8 bilaterally. 0.375% ropivacaine of 20ml is injected separately to both sides with 2ml per hour. Injection is performed twice a day for 7 days or until transferred to the general ward.

Controlled Group:

The patients will receive the clinical routine treatment according of AGI recommended by the 2012 European Society of Critical Care Medicine guidelines, with a uniform nutritional strategy(gastrointestinal dynamic drugs, traditional Chinese drugs and physical rehabilitation therapy).

Course: 7 days Sample size: 100 Sites: 1

Primary endpoints:

  1. the cure rate of AGI
  2. the remission rate of AGI

Secondary endpoints:

  1. critical ill scores
  2. Gastrointestinal function indicators
  3. The inflammatory indicators
  4. the lactic acid(Lac)
  5. cross-sectional area of pyloric antrum(AS) with ultrasound
  6. width of the colons with abdominal X ray or CT
  7. the 28-day mortality
  8. gastrointestinal dysfunction and duration (GIF)

Additional endpoints:

  1. The length of stay in ICU
  2. The total days of hospitalization
Being tested
Ropivacaine injection
Keywords
Acute gastrointestinal injury, Erector spinal muscle plane block, Ropivacaine
Medical subject headings
Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropivacaine injectionDrug

    Also called ropivacaine

    On the first day of inclusion, performed T8 bilateral ultrasound-guided erector spinae plane block and indwelling tube will be left + 0.375% ropivacaine 20ml to both sides. Patients will be given injections every 12 h for 7 days.

Study groups in NCT04934904
Study groupRoleWhat they receive
Experimental GroupExperimentalOn the basis of the clinical routine treatment of AGI in severe patients, the Experimental Group will receives ultrasound-guided erector spinae plane block with routine treatment of AGI for 7 days or until transferring to the general ward.
Receives: Drug: Ropivacaine injection
Controlled GroupNo interventionthe routine clinical treatment of AGI is given to severe patients, such as gastrointestinal dynamic drugs, traditional Chinese drugs and physical rehabilitation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the cure rate of AGI

    the cure rate of AGI on the day3

    Measured: on the day3

  2. the cure rate of AGI

    the cure rate of AGI on the day7

    Measured: on the day7

  3. the remission rate of AGI

    the remission rate of AGI on the day3

    Measured: on the day3

  4. the remission rate of AGI

    the remission rate of AGI on the day7

    Measured: on the day7

Secondary outcomes (19)

  1. Acute Physiology and Chronic Health Evaluation(APACHE II)

    measuring endpoints include:

    body temperature

    mean arterial pressure (MAP)

    heart rate (HR)

    respiratory rate (RR)

    fraction of inspiration O2 (FIO2)

    potential of hydrogen (PH)

    Na+

    K+

    serum creatinine (SCr)

    hematocrit (Hct%)

    white blood cell (WBC)

    Age

    immunosuppression before/after surgery or serious organ dysfunction

    (Higher score means a worse outcome.)

    Measured: on the day 0,1,3 and 7

  2. Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score

    SOFA score evaluate status of the following organ systems separately:

    (Higher score means a worse outcome.)

    1. Respiration Partial Pressure of Oxygen/Fraction of Inspiration O2 (PaO2/FiO2)
    2. Coagulation Platelets
    3. Liver Bilirubin
    4. Circulatory Mean arterial pressure
    5. Central Nervous System Glasgow coma score
    6. Renal Creatinine (or urine output)

    Measured: on the day 0,1,3 and 7

  3. the intraperitoneal pressure(IAP)

    Gastrointestinal function indicators

    Measured: on the day 0,1,3 and 7

  4. abdominal perfusion pressure(AAP)

    Gastrointestinal function indicators

    Measured: on the day 0,1,3 and 7

  5. total gastric residual volume(GRVs)

    Gastrointestinal function indicators

    Measured: on the day 0,1,3 and 7

  6. feeding dose

    Gastrointestinal function indicators

    Measured: on the day 0,1,3 and 7

  7. Gastrointestinal dysfunction and duration(GIF)

    1. fasting(score 1 point)
    2. reflux(score 2 points)
    3. gastrointestinal decompression(1 point)
    4. Gastric retention(2 points)
    5. abdominal distension(2 points)
    6. abdominal pain(2 points)
    7. diarrhea(2 points)
    8. hypoactive bowel sounds(1 point)
    9. bowel sounds disappear(2 points)
    10. constipation(2 points)

    The mentioned indicators will be combined to report GIF in score.

    Grade 0 (Normal) : 0 score

    Grade 1 (Mild) : 1~4 score

    Grade 2 (Medium) : 5~9 score

    Grade 3 (Serious) : >10 score

    Measured: on the day 0,1,3 and 7

  8. Width of the colons

    width of the right colons with abdominal X ray or CT

    Measured: on the day 0,1,3 and 7

  9. White Blood Cell(WBC)

    The inflammatory indicators

    Measured: on the day 0,1,3 and 7

  10. Interleukin-6(IL-6)

    The inflammatory indicators

    Measured: on the day 0,1,3 and 7

  11. Cross-sectional area of pyloric antrum(AS)

    cross-sectional area of pyloric antrum(AS) with ultrasound

    Measured: on the day 0,1,3 and 7

  12. Lymphocyte (LYM)

    The inflammatory indicators

    Measured: on the day 0,1,3 and 7

  13. Neutral Granular Cell(NEUT)

    The inflammatory indicators

    Measured: on the day 0,1,3 and 7

  14. Procalcitonin (PCT)

    The inflammatory indicators

    Measured: on the day 0,1,3 and 7

  15. Hypersensitive C Reactive Protein(HSCRP)

    The inflammatory indicators

    Measured: on the day 0,1,3 and 7

  16. The lactic acid(Lac)

    the serum level of the lactic

    Measured: on the day 0,1,3 and 7

  17. The 28-day mortality

    the 28-day mortality

    Measured: From enrolled to 28 days or the termination date

  18. The length of stay in ICU

    From the date of ICU admission to transfered out.

    Measured: on the day 28 or through study completion

  19. The total days of hospitalization

    from hospital admission to hospital discharge.

    Measured: on the day 28 or through study completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2021
  2. Study start1 Aug 2019
  3. Primary completion23 Aug 2021
  4. Study completion15 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Experimental Group: On the basis of the clinical routine treatment of AGI in severe patients (gastrointestinal dynamic drugs, traditional Chinese drugs and physical rehabilitation therapy), the ultrasound-guided erector spinae plane block intervention is given. Controlled Group: Normal Treatment.
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04934904
Sponsor's protocol ID
2020-KY-032-03
Status last verified
Oct 2021
First submitted
3 Jun 2021
Last updated
9 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ropivacaine injection in people with Gastrointestinal Disease, run by Zhujiang Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the cure rate of AGI (time frame: on the day3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04934904.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.

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