Rectus Sheath Block as an Adjunct to General Anesthesia for Midline Laparotomy Pain (NCT07393763) | Clinical Trial Compass
CompletedNot Applicable
Rectus Sheath Block as an Adjunct to General Anesthesia for Midline Laparotomy Pain
Indonesia46 participantsStarted 2022-02-01
Plain-language summary
This study evaluates whether adding an ultrasound-guided rectus sheath block (RSB) to general anesthesia can improve pain control after midline laparotomy. Adult patients undergoing midline incision laparotomy will be randomly assigned to receive either general anesthesia alone or general anesthesia plus bilateral RSB with local anesthetic (bupivacaine 0.25%). After surgery, pain will be assessed using the Numeric Rating Scale (NRS) at 15 minutes, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours. The study will also compare the time to first opioid request, total opioid use during the first 24 hours after surgery, and changes in inflammation measured by the neutrophil-to-lymphocyte ratio (NLR). The goal is to determine whether RSB can reduce postoperative pain and opioid requirements and help limit postoperative inflammatory response.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18-64 years.
* Patients undergoing midline laparotomy incision (incision extending above to below the umbilicus) for digestive, obstetric, or oncology cases (corresponding to T7-T12 dermatomes) under general anesthesia.
* ASA physical status I-III.
* Body mass index (BMI) 18.5-30 kg/m².
* Willing and able to provide written informed consent.
Exclusion Criteria:
* Refusal to participate.
* Infection or wound at the planned block site.
* Decreased level of consciousness.
* Known allergy to local anesthetics or opioids.
* Coagulation disorder.
* History of chronic pain.
* Hyperalgesia.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.