Clinical trial NCT03945630: Quadratus Lumborum Block in Total Hip Arthroplasty - Effect on Analgesia and Early Physiotherapy
Official title: Quadratus Lumborum Block in Total Hip Arthroplasty - Effect on Analgesia and Early Physiotherapy: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Total Hip Arthroplasty
Keywords: Quadratus Lumborum Block
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * 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)
Primary purpose: TREATMENT

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.

Detailed description: Adequate analgesic strategies for Total Hip Arthroplasty (THA) are of paramount importance in early rehabilitation and enhanced recovery. Ultrasound guided peripheral nerve blocks emerge as the key element of multi-modal analgesia in modern orthopaedic surgery, but in this setting, given the complex sensory innervation of the hip joint, the optimal regional technique for THA is yet to be elucidated. Many centres incorporate Suprainguinal Fascia Iliaca Block in their THA regimen. Although it confers certain benefits, its analgesic efficacy may be suboptimal for posterior approach THA, especially with regards to dermatomal sensory distribution. The Quadratus Lumborum Block (QLB) is a relatively novel technique, yet its role is already established in providing somatic and visceral analgesia for abdominal and pelvic surgery. There are case reports indicating its utility in THA; Adhikary et al. report that QLB is non inferior to Lumbar Plexus Block in terms of its analgesic efficacy, while being easier to perform and carrying less risks.

There remains some debate regarding the QLB mechanism of action. Its clinical effect may be attributed to the spread to thoracic and lumbar paravertebral spaces, spread within the thoracolumbar fascia or even direct spread to the lumbar plexus branches; perhaps all three mechanisms are involved. Thus, QLB is biologically plausible to provide analgesia without significant motor block for posterior approach THA, but for that purpose, neither the optimal volume of local anaesthetic nor the site of injection (anterior vs posterior vs lateral QLB or the vertical height of injection endpoint) have been established in the literature. Based on the available evidence, as well as experience at our institution, the investigators hypothesise, that in patients undergoing THA via posterior approach, anterior QLB at L4 level using 30 ml 0,5% ropivacaine, 100mcg dexmedetomidine and 1:200,000 adrenaline will reduce movement pain scores within the first 24hours, without clinically significant motor block.

The participants will be randomised into one of two groups using an internet based randomisation tool (https://www.randomizer.org/), and subsequently allocated to either group, with the allocation concealed in a sealed opaque envelope.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: NRS score during mobility assessment with physiotherapist
timeFrame: 24 hours
Secondary outcomes:
measure: Serial postoperative NRS pain scores (rest and movement)
timeFrame: 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
measure: Opioid consumption
timeFrame: 48 hours
measure: Time to first request for rescue opioid analgesia
timeFrame: 48 hours
measure: Ability to ambulate with physiotherapist
timeFrame: up to 24 hours
measure: Operated limb sensory block
timeFrame: 6 hours after intervention. Within 24 hours (during the first attempt to ambulate with physiotherapist)
measure: Operated limb muscle weakness
timeFrame: 6 hours after intervention. Within 24 hours (during the first attempt to ambulate with physiotherapist)
measure: Total operation time
timeFrame: During the expected duration of anaesthesia and surgery, which is on average 3 hours
measure: Length of Stay in Recovery area
timeFrame: Expected 30 minutes to 3 hours
measure: The incidence of nausea and/or vomiting
timeFrame: 48 hours
measure: Patient satisfaction with anaesthesia
timeFrame: up to 6 days
measure: Overall patient satisfaction
timeFrame: up to 6 days
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care
Study officials:
affiliation: Medical University of Gdańsk, University Clinical Centre, Gdansk
name: Maciej Kaminski
role: PRINCIPAL_INVESTIGATOR
References: