Quadratus Lumborum Block in Total Hip Arthroplasty - Effect on Analgesia and Early Physiotherapy

NCT03945630 | Suspended

• 1 other identifier: MK-1
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Currently there is no consensus on the optimal peripheral nerve block for Total Hip Arthroplasty (THA). Furthermore, there is a gap in the literature in regard to the efficacy of Quadratus Lumborum Block (QLB) for Total Hip Arthroplasty via posterior approach. This Randomised Controlled Trial aims to examine the effectiveness of anterior QLB in patients undergoing Total Hip Arthroplasty via posterior approach. The investigators hypothesise that anterior QLB and spinal anaesthesia is superior to spinal anaesthesia alone with reference to analgesic efficacy and functional ability to engage with physiotherapy in the first 24 hours postoperatively.

Conditions

Total Hip Arthroplasty

Keywords

Quadratus Lumborum Block

Outcome Measures

Primary Outcomes (1)

• NRS score during mobility assessment with physiotherapist

  Postoperative movement pain score using an 11-point Numeric Rating Scale (NRS) (0- no pain; 10- the worst pain imaginable) during the first postoperative mobility assessment by physiotherapist

  24 hours

Secondary Outcomes (11)

• Serial postoperative NRS pain scores (rest and movement)

  Time Frame: 3 hours after intervention. 6 hours after intervention. At 22:00 hour on Day 0. At 6:00 hour on Day 1. 36 hours after intervention

• Opioid consumption

  48 hours

• Time to first request for rescue opioid analgesia

  48 hours

• Ability to ambulate with physiotherapist

  up to 24 hours

• Operated limb sensory block

  6 hours after intervention. Within 24 hours (during the first attempt to ambulate with physiotherapist)

Study Arms (2)

anterior Quadratus Lumborum Block (QLB)

EXPERIMENTAL

Anterior QLB will be performed in the sitting position. This block is also known as TQL- Transmuscular QLB or QLB 3. A convex transducer will be placed in a transverse position, in the posterior axillary line and tilted caudad until the 'shamrock sign' at L4 level will be obtained. An 80-110 mm SonoTAP (PAJUNK Medizintechnologie, Geisingen, Germany) will be inserted in-plane from the lateral end of the transducer and advanced until the needle tip will be inside the interfascial plane between the Quadratus Lumborum and the Psoas muscles. The successful needle placement will be confirmed by observing the spread of 5 mls 0,9%NaCl. Subsequently, 30 ml 0.5% ropivacaine with 100 mcg dexmedetomidine and adrenaline 1:200,000 will be injected. Satisfactory interfascial spread will be assessed by longitudinal probe orientation. Following QLB, a spinal anaesthetic will be sited and a THA via posterior approach will be performed.

Procedure: anterior Quadratus Lumborum Block

Standard of Care (no QLB)

ACTIVE COMPARATOR

A spinal anaesthetic will be sited and a THA via posterior approach will be performed.

Procedure: Standard of Care

Interventions

anterior Quadratus Lumborum Block PROCEDURE

Interfascial plane block

Also known as: TQL, Transmuscular QLB, QLB 3

anterior Quadratus Lumborum Block (QLB)

Standard of Care PROCEDURE

No QLB

Standard of Care (no QLB)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing unilateral total hip arthroplasty
• Adults 18 - 90 years.
• ASA classification of I, II or III

You may not qualify if:

• Patients with allergies to local anaesthetic
• Patients with pre-existing neurologic or anatomic deficits in the lower extremity on the side of the operation
• BMI \> 40
• Extremes of stature (145cm \> Height \>210cm)
• Patients with co-existing coagulopathy
• Patients refusing spinal anaesthetic or regional block
• Revision hip arthroplasty
• Contraindications to spinal anaesthetic
• Unsatisfactory confirmation of the local anaesthetic spread in the interfascial plane
• Patients requiring transfusion \> 2 units of Red Packed Cells in the postoperative period

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care

Gdansk, 80-214, Poland

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Maciej Kaminski

  Medical University of Gdańsk, University Clinical Centre, Gdansk

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: * Procedure: Quadratus Lumborum Block (QLB) Ultrasound guided Quadratus Lumborum block using an anterior approach. (QLB3; TQL-Transmuscular Quadratus Lumborum) * Procedure: Standard of Care (no QLB)

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 10, 2019
• Study Start: May 14, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 6, 2020

Record last verified: 2020-04

Locations

PL (1)