REctus Sheath Trial
Starting soon · Phase 2
Conditions studied: Acute Pain, Postoperative Pain, Acute
In brief
Regional anesthesia techniques (or nerve blocks) are used to provide sensory blockade over the abdominal wall. The most established technique is thoracic epidural. This provides bilateral spread but is also associated with neuraxial complications, which has led to a decrease in clinical usage. The rectus sheath block (RSB) is an established regional anesthesia technique used to provide somatic analgesia to the midline anterior abdominal wall by depositing local anesthetic in the posterior rectus sheath, thereby targeting the terminal anterior branches of the lower thoracic intercostal nerves. The conventional approach involves placing the ultrasound (US) probe transversely across the rectus abdominis muscle and advancing the needle in-plane either lateral-to-medial or medial-to-lateral. While this technique achieves spread within the sheath, the cephalocaudal distribution of local anesthetic may be suboptimal, potentially limiting the extent of dermatomal coverage. A longitudinal probe orientation, with needle insertion from cephalad to caudad, may theoretically facilitate a more extensive cranio-caudal spread by aligning the injection axis with the anatomical fascial plane of the posterior rectus sheath. However, the relative efficacy of these two approaches has not been investigated in a controlled, comparative setting. Thus, this randomized, single-blinded trial aims to evaluate the dermatomal sensory distribution and ultrasound-assessed local anesthetic spread achieved by the transverse versus longitudinal in-plane approaches to ultrasound-guided RSB in healthy adult volunteers. To compare the dermatomal sensory block distribution, investigators will use dermatomal mapping with pinprick, and cold.
Key facts
- Study ID
- NCT07068243
- Run by
- Duke University
- People needed
- 25
- Starts
- 2026-09-01
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-06-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Ability to provide written informed consent
- Ability and willingness to comply with the study procedures and duration requirements
- ASA physical status 1 or 2
- Age ≥ 18 years
- Weight > 60kg
You may not qualify if…
- BMI > 40kg.m-2
- Use of analgesics within 24 hours before the procedure
- History of abdominal trauma or surgery
- Abdominal deformities or abnormalities that may prevent proper block performance
- Abdominal tattoos in the supraumbilical area
- Systemic neuromuscular disease
- Contraindications to regional anesthesia (e.g., infection, allergy)
- Structures are unable to be visualized by ultrasound
- Pregnancy
- Other known health conditions that would affect the participant's ability to successfully complete the study
Full record on ClinicalTrials.gov
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