NCT07545824

Brief Summary

This prospective observational study aims to evaluate the relationship between ultrasound-derived rectus abdominis muscle thickness and thickening fraction and postoperative opioid consumption in geriatric patients undergoing abdominal surgery. Preoperative ultrasonographic measurements will be performed during routine clinical care, and postoperative pain scores and analgesic requirements will be recorded within the first 24 hours. The findings may help improve individualized analgesic strategies by identifying patient-specific predictors of postoperative opioid needs.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Apr 2026Nov 2026

First Submitted

Initial submission to the registry

April 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

April 25, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 16, 2026

Last Update Submit

April 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative Total Opioid Consumption

    Total opioid consumption within the first 24 hours after surgery will be recorded and converted to morphine equivalents (mg). This measure will be used to evaluate the association between ultrasound-derived rectus abdominis muscle parameters and postoperative analgesic requirements.

    First 24 hours postoperatively

Interventions

Ultrasound-guided rectus sheath block will be performed as part of routine clinical practice in geriatric patients undergoing abdominal surgery. No additional intervention will be introduced for study purposes. Ultrasound-derived rectus abdominis muscle thickness and thickening fraction will be measured preoperatively, and postoperative opioid consumption and pain scores will be recorded within the first 24 hours.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of geriatric patients (≥65 years) scheduled for elective midline abdominal surgery at S.B.U. Haseki Training and Research Hospital. All participants will receive bilateral ultrasound-guided rectus sheath block as part of routine clinical practice under general anesthesia. Eligible patients who meet the inclusion criteria and provide written informed consent will be prospectively enrolled.

You may qualify if:

  • Age ≥65 years
  • Scheduled for elective midline abdominal surgery
  • ASA physical status I-III
  • Planned to receive bilateral ultrasound-guided rectus sheath block as part of routine clinical practice
  • Provided written informed consent

You may not qualify if:

  • Known allergy or hypersensitivity to local anesthetics
  • Infection or skin lesion at the injection site
  • Systemic infection or sepsis
  • Coagulopathy (INR \>1.5 or platelet count \<100,000/mm³)
  • Use of therapeutic anticoagulation not safely managed perioperatively
  • History of previous midline laparotomy
  • History of abdominal mesh implantation or abdominal wall reconstruction
  • Significant abdominal wall pathology (e.g., large hernia) affecting anatomy
  • Neuromuscular disease (e.g., myasthenia gravis, ALS, muscular dystrophy)
  • Inability to perform required maneuver for dynamic ultrasound measurement
  • Moderate to severe cognitive impairment or poor cooperation
  • Body mass index (BMI) \>40 kg/m²
  • Cachexia or severe malnutrition
  • Chronic opioid use (≥3 months)
  • Chronic pain syndromes requiring regular analgesic use
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Location

Related Publications (2)

  • Jeffries SD, Harutyunyan R, Morse J, Hemmerling TM. Investigation into the clinical performance of rectus sheath block in reducing postoperative pain following surgical intervention: A systematic review and meta-analysis of randomised controlled trials. Indian J Anaesth. 2024 Feb;68(2):142-152. doi: 10.4103/ija.ija_1099_23. Epub 2024 Jan 29.

  • Choi ES, Cho SH, Kim JH. Relationship between rectus abdominis muscle thickness and metabolic syndrome in middle-aged men. PLoS One. 2017 Sep 15;12(9):e0185040. doi: 10.1371/journal.pone.0185040. eCollection 2017.

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc.prof

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 22, 2026

Study Start

April 25, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations