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NCT Number: NCT07566312

Study of QL Analgesic Response and Extent

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.

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Key information

About this study

Regional anesthesia techniques are widely employed to achieve sensory blockade of the abdominal wall. Among these, the epidural remains the most well-established approach, offering bilateral spread. However, its association with neuraxial complications has led to a decline in its clinical use. In contrast, fascial plane blocks, avoid neuraxial-related risks. The advent of ultrasound-guided blocks has sparked growing interest in novel fascial plane blocks, that can deliver multi-dermatomal with a lower rate of complications.

Three Quadratus Lumborum (QL) blocks are an example of these fascial plane blocks, commonly performed for abdominal and pelvic surgery. Despite their widespread clinical use, no prior studies have directly compared the three techniques in terms of their cutaneous distribution. Additionally, case reports note that lower extremity weakness can sometimes temporarily occur as a result of accidental spread to the lumbar plexus. Thus, this randomized, double-blinded trial aims to investigate the cutaneous distribution of these three blocks in healthy adult volunteers. Lastly, this study will assess the incidence and severity of lower extremity weakness that may occur with each technique. In addition, this study also seeks to investigate the pharmacokinetics (PK) of lidocaine in each technique. The rationale for this lies in the anatomical differences between the blocks. Theoretically, there may be a difference in the anatomical target for these blocks, but the investigators hypothesize that there is no difference in the local anesthetic absorption. Therefore, as the investigators expect similar systemic absorption, the chances of local anesthetic systemic toxicity (LAST) should be equally low, and all blocks should be similarly safe.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 > 70kg

Exclusion criteria

  • 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
  • Abdominal tattoos in the area of block performance
  • Systemic neuromuscular disease
  • Contraindications to regional anesthesia (e.g., infection, allergy, challenging sonoanatomy)
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Number of participants with blocked areas as measured by skin temperature discrimination

    Time frame: 60 to 90 minutes post-block

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

  2. Number of participants with blocked areas as measured by mechanical discrimination

    Time frame: 60 to 90 minutes post-block

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

  3. Blocked area as measured by cutaneous distribution mapping

    Time frame: 60 to 90 minutes post-block

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

Secondary outcomes

  1. Skin temperature of the chest wall

    Time frame: 60 to 90 minutes post-block

    Infrared camera will assess skin temperature of the chest wall.

  2. Blocked area as measured by nociceptive discrimination

    Time frame: 60 to 90 minutes post-block

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

  3. Lidocaine systemic absorption

    Time frame: 0, 30, 60, 120, and 240 minutes after lidocaine administration

    Calculate lidocaine systemic absorption (Cmax).

Other outcomes

  1. Number of participants with block-related Adverse Events

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

    Any block-related adverse events will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Brian Mendelson, MD

CONTACT

[email protected]

818-456-7040

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Anterior Versus Posterior Versus Lateral Quadratus Lumborum Block: a Randomized Control Trial in Healthy Volunteers

Acronym: SQUARE

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
May 5, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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