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

NCT03551860 | Unknown

• 1 other identifier: 2017/1/01-2018-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Replacement

Keywords

Total hip replacement; Motor block post-operatively; Morphine consumption post-operatively; Transmuscular Quadratus Nerve Block; Fascia Iliaca Nerve Block

Outcome Measures

Primary Outcomes (1)

• 24 hour morphine consumption between the two groups

  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.

  24 hour post-operative period

Secondary Outcomes (2)

• Motor Block

  24 hours post-operative period - measured at 6 and 24 hours

• Numerical Rating Scale (NRS) for Pain

  24 hours post-operative period - measured at 6 and 24 hours

Study Arms (2)

TQL Group

EXPERIMENTAL

Administration of a single shot transmuscular quadratus lumborum (TQL) peripheral nerve block following spinal neuraxial blockade.

Procedure: TQL

FIB Group

ACTIVE COMPARATOR

Administration of a single shot fascia iliac (FIB) peripheral nerve block following spinal neuraxial blockade.

Procedure: FIB

Interventions

TQL PROCEDURE

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.

Also known as: Transmuscular Quadratus Nerve Block

TQL Group

FIB PROCEDURE

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.

Also known as: Fascia Iliaca Nerve Block

FIB Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Local infection
• Allergy to local anaesthetics
• Severe coagulopathy

Sponsors & Collaborators

• The Adelaide and Meath Hospital, incorporating The National Children's Hospital: lead

Study Sites (1)

Adelaide and Meath Hospital, Incorporating National Children Hospital

Tallaght, Dublin 24, Ireland

RECRUITING

Related Publications (4)

• Petis SM, Howard JL, Lanting BA, Marsh JD, Vasarhelyi EM. In-Hospital Cost Analysis of Total Hip Arthroplasty: Does Surgical Approach Matter? J Arthroplasty. 2016 Jan;31(1):53-8. doi: 10.1016/j.arth.2015.08.034. Epub 2015 Aug 29.

  PMID: 26387922 BACKGROUND

• Gaffney CJ, Pelt CE, Gililland JM, Peters CL. Perioperative Pain Management in Hip and Knee Arthroplasty. Orthop Clin North Am. 2017 Oct;48(4):407-419. doi: 10.1016/j.ocl.2017.05.001. Epub 2017 Jun 29.

  PMID: 28870302 BACKGROUND

• Ueshima H, Yoshiyama S, Otake H. RETRACTED: The ultrasound-guided continuous transmuscular quadratus lumborum block is an effective analgesia for total hip arthroplasty. J Clin Anesth. 2016 Jun;31:35. doi: 10.1016/j.jclinane.2015.12.033. Epub 2016 Mar 22.

  PMID: 27185672 BACKGROUND

• La Colla L, Uskova A, Ben-David B. Single-shot Quadratus Lumborum Block for Postoperative Analgesia After Minimally Invasive Hip Arthroplasty: A New Alternative to Continuous Lumbar Plexus Block? Reg Anesth Pain Med. 2017 Jan/Feb;42(1):125-126. doi: 10.1097/AAP.0000000000000523. No abstract available.

  PMID: 27997495 BACKGROUND

Study Officials

• Karthikeyan K Srinivasan, MD.,FCARCSI

  Adelaide and Meath Hospital, Incorporating National Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karthikeyan K Srinivasan, MD.,FCARCSI

CONTACT

0141442653; k.srinivasan@amnch.ie

Barbara Cusack, MCAI

CONTACT

0857139074; barbaracusack@rcsi.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthetist

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: June 11, 2018
• Study Start: April 10, 2018
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)