Ignite Creation Date:
2024-05-06 @ 1:52 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04157855
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2019-11-06
Brief Title:
Abdominal Plane Blocks APB in Chronic Abdominal Pain CAP
Sponsor:
University Hospitals Leicester
Organization:
University Hospitals Leicester
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None