Study of QL Analgesic Response and Extent

ConditionsAcute Pain Postoperative Pain Regional Anesthesia Block

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorDuke University

About this trial

A total of 14-18 healthy volunteers will be included. There will be three different procedure days, separated by at least one week. On each visit, the subjects will receive a QL block, according to the randomization process. Each volunteer will undergo pre-procedure screening on the first visit. The blocks will be performed on the same side, by the same anesthesiologist, with at least one week between each block. An anterior QL block will be administered on one day, a posterior QL block on another, and a lateral QL block on the third. The order will be randomized, and both the subject and the research team member assessing the block will be blinded. To compare the dermatomal sensory block distribution, the investigators will use detailed mapping with pinprick, cold, and heat stimuli. A handheld dynamometric assessment of lower extremity strength. The testing will be performed 60 to 90 minutes after performance of the blocks.

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 > 35kg.m2

Use of analgesics within 24 hours before the procedure

History of thoracic trauma or surgery

Abdominal deformities or abnormalities that may prevent proper block performance

Trial design

Design model

Parallel

Treatments tested in this trial

Quadratus Lumborum with 1.5% Lidocaine
Combination product
For the anterior QL block, a curvilinear probe and nerve stimulator will be used. Local anesthetic will be deposited anterior to the QL muscle but posterior to the psoas muscle. A nerve stimulator at 2 Hz frequency, 1.5 mA will be used to aid in identification of intramuscular placement of the needle. Local anesthetic will only be deposited if no twitch is seen in either the QL or psoas muscle with an appropriate circuit formed. For the posterior QL block, a linear or curvilinear probe will be used, at the discretion of the anesthesiologist. Local anesthetic will be deposited posterior to the QL muscle such that anterior depression of the muscle is seen. For the lateral QL block, local anesthetic will be deposited lateral to the QL muscle.

Treatment groups

25 Participants

are divided into 3 treatment groups

Group A: Lateral Quadratus Lumborum blockActive comparator 1 intervention

Group B: Anterior Quadratus Lumborum BlockExperimental treatment 1 intervention

Group C: Posterior Quadratus Lumborum BlockExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Number of participants with blocked areas as measured by skin 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

Number of participants with blocked areas as measured by 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

Blocked area as measured by cutaneous distribution mapping

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

Time frame

60 to 90 minutes post-block

Secondary outcomes

Skin temperature of the chest wall

Infrared camera will assess skin temperature of the chest wall.

Time frame

60 to 90 minutes post-block

Blocked area as measured by nociceptive discrimination

Nociceptive stimuli will be delivered using controlled heat to discriminate blocked versus unblocked areas on the chest wall.

Time frame

60 to 90 minutes post-block

Lidocaine systemic absorption

Calculate lidocaine systemic absorption (Cmax).

Time frame

0, 30, 60, 120, and 240 minutes after lidocaine administration

Other outcomes

Number of participants with block-related Adverse Events

Any block-related adverse events will be recorded.

Time frame

End of study (2 days post blocks)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: