- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07566312
Study of QL Analgesic Response and Extent (SQUARE)
Anterior Versus Posterior Versus Lateral Quadratus Lumborum Block: a Randomized Control Trial in Healthy Volunteers
Panoramica dello studio
Stato
Intervento / Trattamento
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
Iscrizione (Stimato)
Fase
- Fase 4
Contatti e Sedi
Contatto studio
- Nome: Brian Mendelson, MD
- Numero di telefono: 818-456-7040
- Email: brian.mendelson@duke.edu
Criteri di partecipazione
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
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
Sponsor
Investigatori
- Investigatore principale: Brian Mendelson, MD, Duke University
Studiare le date dei record
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Pro00118381
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