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Completed

NCT Number: NCT04157855

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Leicester General Hospital

Leicester, Leicestershire, LE5 4PW, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Abdominal Plane Block(s) with depot Steroids

Procedure

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 names: Pulsed Radio frequency Treatment to Abdominal Planes

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospitals, Leicester

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 8, 2019
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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