Study of QL Analgesic Response and Extent (SQUARE)
7. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
25
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Brian Mendelson, MD
- Telefonnummer: 818-456-7040
- E-post: brian.mendelson@duke.edu
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
|
Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants with blocked areas as measured by skin temperature discrimination
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Skin temperature of the chest wall
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants with block-related Adverse Events
Tidsramme: End of study (2 days post blocks)
|
Any block-related adverse events will be recorded.
|
End of study (2 days post blocks)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Brian Mendelson, MD, Duke University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. januar 2027
Primær fullføring (Antatt)
1. april 2027
Studiet fullført (Antatt)
1. april 2027
Datoer for studieregistrering
Først innsendt
29. april 2026
Først innsendt som oppfylte QC-kriteriene
29. april 2026
Først lagt ut (Faktiske)
5. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. juli 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00118381
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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