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Study of QL Analgesic Response and Extent (SQUARE)

29 aprile 2026 aggiornato da: Duke University

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

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

25

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Lateral Quadratus Lumborum block
Participants receive quadratus lumborum block under ultrasound guidance, with 30mL of 1.5% lidocaine on one visit.
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.
Sperimentale: Anterior Quadratus Lumborum Block
Participants receive anterior quadratus lumborum block under ultrasound guidance, with 30mL of 1.5% lidocaine on one visit.
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.
Sperimentale: Posterior Quadratus Lumborum Block
Participants receive posterior quadratus lumborum block under ultrasound guidance, with 30mL of 1.5% lidocaine on one visit.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of participants with blocked areas as measured by skin temperature discrimination
Lasso di tempo: 60 to 90 minutes post-block
Skin temperature assessment using gloved ice on the chest wall, to discriminate blocked vs unblock areas.
60 to 90 minutes post-block
Number of participants with blocked areas as measured by mechanical discrimination
Lasso di tempo: 60 to 90 minutes post-block
Mechanical assessment using a neuropin (pinprick) on the chest wall, to discriminate blocked vs unblock areas.
60 to 90 minutes post-block
Blocked area as measured by cutaneous distribution mapping
Lasso di tempo: 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.
60 to 90 minutes post-block

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Skin temperature of the chest wall
Lasso di tempo: 60 to 90 minutes post-block
Infrared camera will assess skin temperature of the chest wall.
60 to 90 minutes post-block
Blocked area as measured by nociceptive discrimination
Lasso di tempo: 60 to 90 minutes post-block
Nociceptive stimuli will be delivered using controlled heat to discriminate blocked versus unblocked areas on the chest wall.
60 to 90 minutes post-block
Lidocaine systemic absorption
Lasso di tempo: 0, 30, 60, 120, and 240 minutes after lidocaine administration
Calculate lidocaine systemic absorption (Cmax).
0, 30, 60, 120, and 240 minutes after lidocaine administration

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of participants with block-related Adverse Events
Lasso di tempo: End of study (2 days post blocks)
Any block-related adverse events will be recorded.
End of study (2 days post blocks)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: Brian Mendelson, MD, Duke University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 novembre 2026

Completamento dello studio (Stimato)

1 dicembre 2026

Date di iscrizione allo studio

Primo inviato

29 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

5 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Dolore postoperatorio

Prove cliniche su Quadratus Lumborum with 1.5% Lidocaine

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