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

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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Pain; Abdominal Myofascial Pain Syndrome (AMPS); Abdominal Plane Blocks (APB)
• Intervention / Treatment: Procedure: Abdominal Plane Block(s) with depot Steroids

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United Kingdom
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE5 4PW
      • Leicester General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Data will be obtained from an online hospital database (ICE)	12 months

Collaborators and Investigators

• Sponsor: University Hospitals, Leicester
• Investigators: Principal Investigator: Niraj Gopinath, MD, University Hospitals, Leicester

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2019
• Primary Completion (Actual): April 8, 2022
• Study Completion (Actual): April 8, 2022

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Abdominal Pain; Myofascial Pain Syndromes
• Other Study ID Numbers: 113764

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No