REctus Sheath Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 1.0% lidocaine with epinephrine (1:100,000).
- Who it may be relevant to
- Registry conditions: Acute Pain, Postoperative Pain, Acute. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Transverse Versus Longitudinal Approaches for Rectus Sheath Block: a Randomized Controlled Trial in Healthy Volunteers
Overview
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.
Detailed description
A total of 14-18 adult volunteers will be included. Each participant will receive bilateral rectus sheath blocks at a standardized supraumbilical level. The side receiving the transverse approach (US probe perpendicular to muscle fibers; needle in-plane lateral-to-medial) and the side receiving the longitudinal approach (US probe parallel to muscle fibers; needle in-plane cephalad-to-caudad) will be randomized. The blocks will be performed with a standardized volume and concentration of local anesthetic, under real-time US guidance by the same experienced anesthesiologist. The research team member assessing the block will be blinded. Immediately after injection of each block, US imaging will be used to assess and measure the length and pattern of spread within the posterior rectus sheath. At baseline and at 60 minutes post-block, dermatomal sensory mapping will be performed using standardized cold and pinprick stimuli over the anterior abdominal wall.
Interventions
- Drug 1.0% lidocaine with epinephrine (1:100,000)
The block will be performed by advancing the needle into the posterior rectus sheath compartment, with the local anesthetic deposited posterior to the rectus abdominis muscle and anterior to the posterior rectus sheath. Drug: 20 mL injection of 1.0% lidocaine with epinephrine (1:100,000) on each side (40mL total/subject)
Primary outcome measures
- Temperature discrimination [Time frame: 60 to 90 minutes post-block]
- Mechanical discrimination [Time frame: 60 to 90 minutes post-block]
- Cutaneous distribution mapping [Time frame: 60 to 90 minutes post-block]
Secondary outcome measures (2)
- Direct visualization of the local anesthetic spread [Time frame: Immediately post-block]
- Measurement of the local anesthetic spread in each dermatome with the US [Time frame: Immediately post-block]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07068243 · Pro00118293