Does Pre-operative Gastric Ultrasound Influence Anaesthetic Decision-Making in Chronic Pain Patients? A Prospective Observational Cohort.

NCT07537582 | Not Yet Recruiting

• 1 other identifier: RPDAE/2026/102
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Gastric POCUS has been validated and shown to be an accurate diagnostic tool in both healthy individuals and medically complex patient populations. Regional anaesthesiologists and pain management physicians frequently provide sedation or anaesthetic care for medically complex patients who fall outside the limited applicability of existing fasting guidelines, including patients with chronic pain, poor acute-on-chronic pain control, and those receiving acute or chronic opioid therapy. These patients are at risk of delayed gastric emptying and may therefore benefit from additional pre-procedural assessment using gastric ultrasound prior to elective interventions

Conditions

Gastric Ultrasound; Gastric Ultrasound in Chronic Opioid Use (≥2 Weeks); Gastric Ultrasound in Poorly Controlled Acute-on-chronic Pain; Gastric Ultrasound in Acute Opioid Administration Within 24 Hours Prior to the Procedure; Gastric Ultrasound in Diabetes Mellitus Without Established Autonomic Neuropathy; Gastric Ultrasound in Patient With Symptoms of Gastroesophageal Reflux; Gastric Ultrasound in Patients With Reduced Functional Mobility

Keywords

Gastric Ultrasound for patients with chronic pain undergoing interventional procedures under sedation; Gastric Ultrasound; Patients with chronic pain

Outcome Measures

Primary Outcomes (1)

• The proportion of patients in whom pre-procedural gastric ultrasound resulted in a change to the pre-defined anesthetic management plan.

  The Percentage of patients from the total number of patients involved in the study, in whom pre-procedural gastric ultrasound reveals signs of high aspiration risk which needed a change to the pre-defined anesthetic management plan, A management change was defined as any deviation from the originally documented sedation or airway strategy following review of ultrasound findings. (Patients with solid or mixed gastric contents, or fluid contents with a gastric volume of \>1.5 ml·kg-¹ body weight are classified as having a high aspiration risk).

  1- 2 hours

Secondary Outcomes (3)

• Prevalence of high-risk gastric contents despite adherence to fasting guidelines

  1- 2 hours

• Associations between gastric ultrasound findings and patient-related factors, including opioid use and comorbidities

  1-2 hours

• Qualitative and quantitative gastric ultrasound findings

  1-2 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This will be a single-center, prospective observational cohort study conducted at Danat Al Emarat Hospital, Abu Dhabi, UAE. Adult patients scheduled for elective chronic pain interventional procedures under procedural sedation will be screened for eligibility.

You may qualify if:

• Age ≥18 years
• Scheduled for elective chronic pain interventional procedures under procedural sedation
• Adherence to standard preoperative fasting guidelines (≥6 hours for clear fluids and ≥8 hours for solids)
• Presence of at least one clinical factor associated with delayed gastric emptying or increased risk of pulmonary aspiration, including:
• Chronic opioid use (≥2 weeks)
• Acute opioid administration within 24 hours prior to the procedure
• Poorly controlled acute-on-chronic pain
• Diabetes mellitus without established autonomic neuropathy
• Symptoms of gastroesophageal reflux
• Reduced functional mobility
• ASA physical status II-III

You may not qualify if:

• Age \<18 years
• Previous gastric or esophageal surgery
• Known pregnancy
• Known hiatal hernia
• Severe neurological disorders affecting swallowing or gastric motility
• Established autonomic neuropathy affecting gastric emptying (e.g. advanced diabetic gastroparesis)
• Morbid obesity (body mass index ≥35 kg·m-²), due to known limitations in gastric ultrasound image acquisition and reduced validity of volume estimation models
• Inability to provide informed consent

Sponsors & Collaborators

• Danat Al Emarat Hospital: lead

Study Sites (1)

Danat Al Emarat Women & Children Hospital

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates

Location

Related Publications (9)

• Gola W, Domagala M, Cugowski A. Ultrasound assessment of gastric emptying and the risk of aspiration of gastric contents in the perioperative period. Anaesthesiol Intensive Ther. 2018;50(4):297-302. doi: 10.5603/AIT.a2018.0029. Epub 2018 Sep 17.

  PMID: 30221339 BACKGROUND

• Charlesworth M, Wiles MD. Pre-operative gastric ultrasound - should we look inside Schrodinger's gut? Anaesthesia. 2019 Jan;74(1):109-112. doi: 10.1111/anae.14516. No abstract available.

  PMID: 30511749 BACKGROUND

• Pan X, Chai J, Gao X, Li S, Liu J, Li L, Li Y, Li Z. Diagnostic performance of ultrasound in the assessment of gastric contents: a meta-analysis and systematic review. Insights Imaging. 2024 Mar 27;15(1):98. doi: 10.1186/s13244-024-01665-0.

  PMID: 38536581 BACKGROUND

• Haskins SC, Kruisselbrink R, Boublik J, Wu CL, Perlas A. Gastric Ultrasound for the Regional Anesthesiologist and Pain Specialist. Reg Anesth Pain Med. 2018 Oct;43(7):689-698. doi: 10.1097/AAP.0000000000000846.

  PMID: 30052550 BACKGROUND

• Perlas A, Van de Putte P, Van Houwe P, Chan VW. I-AIM framework for point-of-care gastric ultrasound. Br J Anaesth. 2016 Jan;116(1):7-11. doi: 10.1093/bja/aev113. Epub 2015 May 7. No abstract available.

  PMID: 25951832 BACKGROUND

• Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.

  PMID: 29624530 BACKGROUND

• Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250.

  PMID: 19512861 BACKGROUND

• Bouvet L, Mazoit JX, Chassard D, Allaouchiche B, Boselli E, Benhamou D. Clinical assessment of the ultrasonographic measurement of antral area for estimating preoperative gastric content and volume. Anesthesiology. 2011 May;114(5):1086-92. doi: 10.1097/ALN.0b013e31820dee48.

  PMID: 21364462 BACKGROUND

• Perlas A, Mitsakakis N, Liu L, Cino M, Haldipur N, Davis L, Cubillos J, Chan V. Validation of a mathematical model for ultrasound assessment of gastric volume by gastroscopic examination. Anesth Analg. 2013 Feb;116(2):357-63. doi: 10.1213/ANE.0b013e318274fc19. Epub 2013 Jan 9.

  PMID: 23302981 BACKGROUND

Central Study Contacts

JINAN JAMEEL AL ALOOSI, CONSULTANT ANESTHESIOLOGIST

CONTACT

+97150 7291195; jinan.jameel@danatalemarat.ae

Waleed Riad, Pain medicine Anesthesiologist

CONTACT

+97152 5773423; waleed.riad@danatalemarat.ae

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anesthesiologist

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: April 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)