NCT07566312

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
7mo left

Started May 2026

Shorter than P25 for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
May 2026Dec 2026

First Submitted

Initial submission to the registry

April 29, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 29, 2026

Last Update Submit

April 29, 2026

Conditions

Keywords

Quadratus lumborum blockQL blockQLQuadratus lumborumFascial plane blockRegional anesthesiaAbdominal blocks

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    60 to 90 minutes post-block

Secondary Outcomes (3)

  • Skin temperature of the chest wall

    60 to 90 minutes post-block

  • Blocked area as measured by nociceptive discrimination

    60 to 90 minutes post-block

  • Lidocaine systemic absorption

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

Other Outcomes (1)

  • Number of participants with block-related Adverse Events

    End of study (2 days post blocks)

Study Arms (3)

Lateral Quadratus Lumborum block

ACTIVE COMPARATOR

Participants receive quadratus lumborum block under ultrasound guidance, with 30mL of 1.5% lidocaine on one visit.

Combination Product: Quadratus Lumborum with 1.5% Lidocaine

Anterior Quadratus Lumborum Block

EXPERIMENTAL

Participants receive anterior quadratus lumborum block under ultrasound guidance, with 30mL of 1.5% lidocaine on one visit.

Combination Product: Quadratus Lumborum with 1.5% Lidocaine

Posterior Quadratus Lumborum Block

EXPERIMENTAL

Participants receive posterior quadratus lumborum block under ultrasound guidance, with 30mL of 1.5% lidocaine on one visit.

Combination Product: Quadratus Lumborum with 1.5% Lidocaine

Interventions

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.

Anterior Quadratus Lumborum BlockLateral Quadratus Lumborum blockPosterior Quadratus Lumborum Block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute PainPain, Postoperative

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Brian Mendelson, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Mendelson, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2026

First Posted

May 5, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share