REctus Sheath Trial

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Drug

    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)

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Transverse Approach to the Rectus Sheath BlockActive comparator 1 intervention
Group B: Longitudinal Approach to the Rectus Sheath BlockExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Temperature discrimination

Skin temperature assessment using gloved ice on the chest wall, to discriminate blocked vs unblock areas.

Time frame
60 to 90 minutes post-block
2

Mechanical discrimination

Mechanical assessment using a neuropin (pinprick) on the chest wall, to discriminate blocked vs unblock areas.

Time frame
60 to 90 minutes post-block
3

Cutaneous distribution mapping

Mapping the blocked area (using the previous temperature and mechanical assessments, demarcating lines on the skin) to provide a visual map and, to calculate the area blocked.

Time frame
60 to 90 minutes post-block

Secondary outcomes

1

Direct visualization of the local anesthetic spread

Direct visualization of the local anesthetic spread cephalad and caudad, marking the highest and lowest dermatomes where local anesthetic was still seen on the US, with the US oriented longitudinally.

Time frame
Immediately post-block
2

Measurement of the local anesthetic spread in each dermatome with the US

Measurement of the local anesthetic spread in each dermatome with the US oriented transversely, by measuring hypoecoic area produced by the presence of local anesthetic.

Time frame
Immediately post-block

Other outcomes

1

Adverse Events

Any adverse events block-related will be recorded

Time frame
End of study (2 days post blocks).

Locations

This trial has no locations.

Sponsors and contacts

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