Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Quadratus Lumborum Block Versus Fascia Iliaca Nerve Block for Patients Undergoing Total Hip Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03551860
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Karthikeyan Kallidaikurichi Srinivasan, The Adelaide and Meath Hospital, incorporating The National Children's Hospital

Brief Summary:
Investigators hypothesise that for patients undergoing elective total hip replacements, a single injection Transmuscular Quadratus Lumborum (TQL) block, when compared to a single injection Fascia Iliaca Block (FIB), will provide better analgesia and less motor block in the initial 24 hour period.

Condition or disease Intervention/treatment Phase
Hip Replacement Procedure: TQL Procedure: FIB Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Due to nature of intervention (one single injection vs a second single injection in different anatomical location) the participant and the care provider cannot be blinded.The investigator will use an already filled data collection sheet and enter randomised data into a master file. The data will be analysed by an individual blinded to the which group the participant was in.
Primary Purpose: Treatment
Official Title: A Comparative Evaluation of Quadratus Lumborum Block Versus Fascia Iliaca Nerve Block for Patients Undergoing Elective Total Hip Replacement Under Spinal Anaesthesia
Actual Study Start Date : April 10, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Experimental: TQL Group
Administration of a single shot transmuscular quadratus lumborum (TQL) peripheral nerve block following spinal neuraxial blockade.
Procedure: TQL

For the intervention of TQL peripheral nerve block the needle tip will be advanced by in-plane technique and local anaesthetic will be deposited between psoas major and quadratus lumborum muscles. 20 ml of 0.25% bupivacaine will be administered under ultrasound guidance following careful intermittent aspiration. The needle tip will not be repositioned unless the patient complains of paraesthesia.

For the intervention of spinal neuraxial blockade the needle will be advanced into the subarachnoid space. Once clear CSF is visualised 3.2ml 0.5% plain bupivacaine will be infiltrated.

Other Name: Transmuscular Quadratus Nerve Block

Active Comparator: FIB Group
Administration of a single shot fascia iliac (FIB) peripheral nerve block following spinal neuraxial blockade.
Procedure: FIB

The needle tip will be advanced by in-plane technique and local anaesthetic will be deposited deep to the fascia iliaca. 20ml of 0.25% bupivacaine will be administered under ultrasound guidance following careful intermittent aspiration. The needle tip will not be repositioned unless the patient complains of paraesthesia.

For the intervention of spinal neuraxial blockade the needle will be advanced into the subarachnoid space. Once clear CSF is visualised 3.2ml 0.5% plain bupivacaine will be infiltrated.

Other Name: Fascia Iliaca Nerve Block




Primary Outcome Measures :
  1. 24 hour morphine consumption between the two groups [ Time Frame: 24 hour post-operative period ]
    Intravenous Patient Controlled Analgesia (PCA) Morphine will be set up and explained to all participants. The AMNCH hospital standard will be use. This is 2mg/ml concentration; 1mg dose; 6 minute lockout period between administration; maximum morphine consumption of 40mg within a 4 hour period.


Secondary Outcome Measures :
  1. Motor Block [ Time Frame: 24 hours post-operative period - measured at 6 and 24 hours ]

    Modified Bromage Scale for use in Lower Limb will be used to assess residual motor block.

    Scale ranges:

    1. Complete block (unable to move feet or knee)
    2. Almost complete block (able to move feet only)
    3. Partial block (just able to move knees)
    4. Detectable weakness of hip flexion while supine (full flexion of knees)
    5. No detectable weakness of hip flexion while supine
    6. Able to perform partial knee bend.

    The higher the number value the better the outcome is considered to be and the less the residual nerve block.


  2. Numerical Rating Scale (NRS) for Pain [ Time Frame: 24 hours post-operative period - measured at 6 and 24 hours ]
    A Numerical Rating Scale is an 11 point scale that involves asking a patient to rate his or her pain from 0 to 10 with the understanding that 0 is equal to no pain and 10 is equal to the worst pain possible. The patient provides a verbal response to which the assessor can document the intensity of pain the patient reports.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing elective total hip replacements under spinal anaesthesia
  • ASA 1-3
  • Age > 18 yrs.
  • Patient is able to provide written informed consent

Exclusion Criteria:

  • Local infection
  • Allergy to local anaesthetics
  • Severe coagulopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551860


Contacts
Layout table for location contacts
Contact: Karthikeyan K Srinivasan, MD.,FCARCSI 0141442653 k.srinivasan@amnch.ie
Contact: Barbara Cusack, MCAI 0857139074 barbaracusack@rcsi.ie

Locations
Layout table for location information
Ireland
Adelaide and Meath Hospital, Incorporating National Children Hospital Recruiting
Tallaght, Dublin 24, Ireland
Contact: Karthikeyan Srinivasan, MD.,FCARCSI    0141442653    k.srinivasan@amnch.ie   
Sponsors and Collaborators
The Adelaide and Meath Hospital, incorporating The National Children's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Karthikeyan K Srinivasan, MD.,FCARCSI Adelaide and Meath Hospital, Incorporating National Children's Hospital
  Study Documents (Full-Text)

Documents provided by Karthikeyan Kallidaikurichi Srinivasan, The Adelaide and Meath Hospital, incorporating The National Children's Hospital:
Informed Consent Form  [PDF] April 30, 2018
Study Protocol  [PDF] April 30, 2018


Publications:
Layout table for additonal information
Responsible Party: Karthikeyan Kallidaikurichi Srinivasan, Consultant Anaesthetist, The Adelaide and Meath Hospital, incorporating The National Children's Hospital
ClinicalTrials.gov Identifier: NCT03551860     History of Changes
Other Study ID Numbers: 2017/1/01-2018-01
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karthikeyan Kallidaikurichi Srinivasan, The Adelaide and Meath Hospital, incorporating The National Children's Hospital:
Total hip replacement
Motor block post-operatively
Morphine consumption post-operatively
Transmuscular Quadratus Nerve Block
Fascia Iliaca Nerve Block