Postoperative PainNCT07545824
Rectus Abdominis Muscle Parameters and Postoperative Opioid Consumption in Geriatric Patients
An observational study of Postoperative Pain, run by Istinye University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ultrasound-Guided Rectus Sheath Block
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2026to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
- Alcohol or substance abuse
- Emergency surgery
- Use of additional regional anesthesia techniques (e.g., epidural, TAP block)
- Inadequate ultrasound visualization of the target anatomical plane
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250
About this study
Official title: Association Between Ultrasound-Derived Rectus Abdominis Muscle Thickness and Thickening Fraction and Postoperative Opioid Consumption in Geriatric Patients Undergoing Abdominal Surgery: A Prospective Observational Study
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.
- Conditions
- Postoperative Pain
- Being tested
- Ultrasound-Guided Rectus Sheath Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Rectus Sheath BlockOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start25 Apr 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545824
- Sponsor's protocol ID
- rektus kas kalınlığı
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38435659Choi 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.
PubMed 28915276
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Ultrasound-Derived Rectus Abdominis Muscle Thickness and Thickening Fraction and Postoperative Opioid Consumption in Geriatric Patients Undergoing Abdominal Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07545824
- Acronym / sponsor ID
- rektus kas kalınlığı
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 25 Apr 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Rectus Sheath BlockUltrasound-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. | Other | – |
Primary outcome
Postoperative Total Opioid Consumption
Time frame: First 24 hours postoperatively
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 38435659Jeffries 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.
- Results publication: PubMed 28915276Choi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact İlke Dolgun (5555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Total Opioid Consumption (time frame: First 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07545824, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.