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Abdominal Plane Blocks (APB) in Chronic Abdominal Pain (CAP)

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ClinicalTrials.gov Identifier: NCT04157855
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospitals, Leicester

Brief Summary:

Background: Chronic Abdominal Pain (CAP) is the sixth most common cause of hospital admission from any cause in women and the tenth most common cause in men. In the UK, it has been estimated that chronic abdominal pain costs the economy in excess of £100 million per annum. The mechanism of CAP is poorly understood. Patients with acute exacerbation of their CAP have multiple hospital admissions, prolonged length of stay and utilise significant health care resources. These patients have undergone multiple investigations with negative results leading to frustration for both the patient and the clinician. Additional testing and investigations increases costs, patient morbidity and comes with added risks. Patients are discharged once the flare up settles. The investigators have shown that treating patients with steroid injection followed by pulsed radio frequency treatment six months later can reduce the length of stay, repeat hospital admission, improve mood and provide durable pain relief in patients with CAP. The steroid is injected into a specific plane in the abdominal wall and is called abdominal plane block (APB). The investigators currently offer ABP treatment as a standard treatment in the management of patients with CAP.

Aim of the study is to evaluate the effectiveness of Abdominal Plane Block (APB) treatment in reducing hospital readmission over 12 months in patients admitted with exacerbation of CAP

Methods: The proposed study is a prospective, observational pilot study that will be conducted at Leicester General Hospital over 36 months. After providing written consent, adult patients admitted to the hospital with acute exacerbation of CAP will receive two sequential APB treatments (steroid injection followed by pulsed radio frequency treatment) six month apart. If the first treatment with steroid does not provide any benefit, the participants will receive a rescue treatment (trigger point injection with steroids). Participants will be asked to complete questionnaires on pain scores, mood and quality of life. Length of hospital stay, number of hospital re-admission following APB treatment as well as any complication from the APB treatment will be recorded. Participation in the study will end at 12 months following the first APB treatment on completion of relevant questionnaires.


Condition or disease Intervention/treatment
Abdominal Pain Abdominal Myofascial Pain Syndrome (AMPS) Abdominal Plane Blocks (APB) Procedure: Abdominal Plane Block(s) with depot Steroids

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effectiveness of Abdominal Plane Block (APB) Treatment in the Management and Early Hospital Discharge of Patients Presenting With Acute Exacerbation of Chronic Abdominal Pain (CAP): an Observational Pilot Study
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : January 8, 2022
Estimated Study Completion Date : January 30, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Abdominal Plane Block(s) with depot Steroids
    APB Steroids treatment: under real time ultrasound guidance, a 100 mm needle is introduced into the specified plane (subcostal TAP for upper abdomen pain, posterior TAP for lower abdomen pain or TQL for flank and lower abdominal pain). Normal saline (10 ml) is used to open the fascial plane (saline hydrodissection). Then 40 mg of depomedrone diluted in 10 ml of 0.25% levo-bupivacaine is injected into the plane. . A total of 80 mg of depomedrone (steroid) will be used.
    Other Name: Pulsed Radio frequency Treatment to Abdominal Planes


Primary Outcome Measures :
  1. Primary outcome will be the number of hospital admissions in 12 months following the first Abdominal Plane Block (APB) treatment when compared to 12 months before the first APB treatment [ Time Frame: 12 months ]
    Data will be obtained from an online hospital database (ICE)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study is based on a cohort of adult patients who are admitted to the hospital with acute exacerbation of chronic abdominal pain.

Chronic Abdominal Pain is defined as persistent abdominal pain that lasts for more than three months.

Criteria

Inclusion Criteria:

  1. All patients aged over 18 years.
  2. Chronic abdominal pain for above 6 months
  3. Moderate to severe pain in the abdomen: Baseline NRS >4 (worst pain the last 24 hours)

Exclusion Criteria:

  1. Lack of consent, including from those patients who lack mental capacity to give informed consent.
  2. Patients with known history of drug allergy to depomedrone
  3. Patients with infection at injection site at on day of treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157855


Contacts
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Contact: Niraj Gopinath, MD 01162588253 niraj.g@nihr.ac.uk

Locations
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United Kingdom
Leicester General Hospital Recruiting
Leicester, Leicestershire, United Kingdom, LE5 4PW
Contact: Lisa Wann    +44 116 258 8239      
Sponsors and Collaborators
University Hospitals, Leicester
Investigators
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Principal Investigator: Niraj Gopinath, MD University Hospitals, Leicester

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Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT04157855    
Other Study ID Numbers: 113764
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Fibromyalgia
Abdominal Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases