Recruiting
Phase 2

RSB Techniques

Sponsor:

Duke University

Code:

NCT07068243

Conditions

Acute Pain

Postoperative Pain, Acute

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

1.0% lidocaine with epinephrine (1:100,000)

Study Details

Brief summary:

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.

Conditions

Acute Pain

Postoperative Pain, Acute

Study ID

NCT07068243

Start date

Oct 26, 2026

Status verified date

Nov, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion criteria:

1. Ability to provide written informed consent
2. Ability and willingness to comply with the study procedures and duration requirements
3. ASA physical status 1 or 2
4. Age ≥ 18 years
5. Weight > 60kg

Exclusion criteria:

1. BMI > 40kg.m-2
2. Use of analgesics within 24 hours before the procedure
3. History of abdominal trauma or surgery
4. Abdominal deformities or abnormalities that may prevent proper block performance
5. Abdominal tattoos in the supraumbilical area
6. Systemic neuromuscular disease
7. Contraindications to regional anesthesia (e.g., infection, allergy)
8. Structures are unable to be visualized by ultrasound
9. Pregnancy
10. Other known health conditions that would affect the participant's ability to successfully complete the study

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Transverse Approach to the Rectus Sheath Block

In the transverse approach, the US probe will be positioned perpendicular to the he rectus abdominis muscle's fibers, and the needle will be inserted in-plane from lateral to medial.

experimental: Longitudinal Approach to the Rectus Sheath Block

In contrast, the longitudinal approach will involve aligning the probe parallel to the rectus muscle fibers, with the needle advanced in-plane from cephalad to caudad.

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

More Information

Sponsor

Duke University

Last update posted

Nov 6, 2026

Last verified

Nov, 2026

Keywords

  • Rectus Sheath Block
  • Abdominal Block
  • Fascial Plane Block
  • RSB

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-08. This information was provided to ClinicalTrials.gov by Duke University on 2026-11-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.