NCT03100994

Brief Summary

Post-operative analgesia efficacy using ultrasound-guided transmuscular quadratus lumborum block versus ultrasound-guided quadratus lumborum type II block

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 24, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

March 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

March 24, 2017

Last Update Submit

March 29, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • morphine consumption

    morphine consumption

    48 hours

Secondary Outcomes (4)

  • Severity of postoperative pain via visual analogue pain scale (VAS)

    48 hours

  • Nausea or vomiting

    48 hours

  • time to mobilization

    48 hours

  • Skin itch

    48 hours

Study Arms (3)

Group A

NO INTERVENTION

without nerve block

Group B

ACTIVE COMPARATOR

Ultrasound guided transmuscular quadratus lumborum block with 0.125% bupivacaine 30ml

Drug: BupivacaineDevice: Ultrasound

Group C

ACTIVE COMPARATOR

Ultrasound guided quadratus lumborum type 2 block with 0.125% bupivacaine 30ml

Drug: BupivacaineDevice: Ultrasound

Interventions

injecting anesthetics to different local

Also known as: Marcaine
Group BGroup C

Ultrasound guided nerve block

Also known as: Philp
Group BGroup C

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists classification (ASA) 1\~3
  • adequate communication skills
  • Body mass index \< 32

You may not qualify if:

  • chronic pain neurological illness/ neuropathy contraindication against local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-Service General Hospital

Taipei, 114, Taiwan

RECRUITING

Related Publications (2)

  • Adhikary SD, El-Boghdadly K, Nasralah Z, Sarwani N, Nixon AM, Chin KJ. A radiologic and anatomic assessment of injectate spread following transmuscular quadratus lumborum block in cadavers. Anaesthesia. 2017 Jan;72(1):73-79. doi: 10.1111/anae.13647. Epub 2016 Oct 12.

  • Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.

MeSH Terms

Interventions

BupivacaineUltrasonography

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Hsuan-Cheng Wu

    Tri-Service General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsuan-Cheng Wu, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 3 group: Group A: without intervention; Group B: Ultrasound-guided transmuscular quadratus lumborum block; Group C: Ultrasound-guided quadratus lumborum type II block
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Department of Anesthesiology,Tri-ServiceGeneralHospital

Study Record Dates

First Submitted

March 24, 2017

First Posted

April 4, 2017

Study Start

March 28, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

April 4, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations