Post-operative Analgesia Efficacy Using Ultrasound-guided Transmuscular Quadratus Lumborum Block Versus Ultrasound-guided Quadratus Lumborum Type II Block.

March 29, 2017 updated by: Wu Hsuan-Cheng, Tri-Service General Hospital
Post-operative analgesia efficacy using ultrasound-guided transmuscular quadratus lumborum block versus ultrasound-guided quadratus lumborum type II block

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The Quadratus Lumborum (QL) Block is an ultrasound-guided technique described by Rafael Blanco in 2007. The nerves to the lower abdominal wall can be anesthetized by injecting local anesthetics between the quadratus lumborum muscle and latissimus dorsi muscle, which is called quadratus lumborum type II block. 〝 Transmuscular quadratus lumborum block demonstrates that injectate spreads over the posterior abdominal wall to the psoas major muscle and includes the upper branches of the lumbar plexus.〞described by Adhikary in 2016. However there are no published reports comparing the 2 techniques. In our study, compared of ultrasound-guided QL2-blocks with transmuscular quadratus lumborum block to investigate analgesic consumption, pain level, opioid related side effects and mobilization.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 114
        • Recruiting
        • Tri-Service General Hospital
        • Contact:
          • Shih-Hua Lin, PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

chronic pain neurological illness/ neuropathy contraindication against local anesthetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group A
without nerve block
Active Comparator: Group B
Ultrasound guided transmuscular quadratus lumborum block with 0.125% bupivacaine 30ml
Drug: Bupivacaine
injecting anesthetics to different local
Other Names:
  • Marcaine
Device: Ultrasound
Ultrasound guided nerve block
Other Names:
  • Philp
Active Comparator: Group C
Ultrasound guided quadratus lumborum type 2 block with 0.125% bupivacaine 30ml
Drug: Bupivacaine
injecting anesthetics to different local
Other Names:
  • Marcaine
Device: Ultrasound
Ultrasound guided nerve block
Other Names:
  • Philp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morphine consumption
Time Frame: 48 hours
morphine consumption
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of postoperative pain via visual analogue pain scale (VAS)
Time Frame: 48 hours
Total cumulative morphine dose in mg used in the first 48 hours after surgery
48 hours
Nausea or vomiting
Time Frame: 48 hours
Severity of nausea or vomiting in the first 48 hours after surgery. Severe :3 Moderate:2 Mild:1 None: 0
48 hours
time to mobilization
Time Frame: 48 hours
Time to mobile in the first 48 hours after surgery
48 hours
Skin itch
Time Frame: 48 hours
Severity of skin itch in the first 48 hours after surgery. Severe :3 Moderate:2 Mild:1 None: 0
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Investigators

  • Principal Investigator: Hsuan-Cheng Wu, Tri-Service General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2017

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

March 24, 2017

First Submitted That Met QC Criteria

March 29, 2017

First Posted (Actual)

April 4, 2017

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-105-05-157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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