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

Quadratus Lumborum Block in Total Hip Arthroplasty - Effect on Analgesia and Early Physiotherapy: a Randomised Controlled Trial

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03945630
Enrollment
62
Registered
2019-05-10
Start date
2019-05-14
Completion date
2020-04-30
Last updated
2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Hip Arthroplasty

Keywords

Quadratus Lumborum Block

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.

Interventions

Interfascial plane block

PROCEDUREStandard of Care

No QLB

Sponsors

Medical University of Gdansk
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

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)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
NRS score during mobility assessment with physiotherapist24 hoursPostoperative 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

Secondary

MeasureTime frameDescription
Opioid consumption48 hoursOpioid consumption (oxycodone)
Time to first request for rescue opioid analgesia48 hoursTime to first request for a rescue opioid administration (PRN oxycodone)
Ability to ambulate with physiotherapistup to 24 hoursDistance in metres will be recorded during the first attempt to ambulate with physiotherapist (usually on Day 1)
Operated limb sensory block6 hours after intervention. Within 24 hours (during the first attempt to ambulate with physiotherapist)The level of sensory block (to cold temperature), tested with cold spray, will be recorded by a trained assessor on the dermatome map chart.
Operated limb muscle weakness6 hours after intervention. Within 24 hours (during the first attempt to ambulate with physiotherapist)QLB's effect on muscles involved in hip joint movement will be evaluated. Additionally, muscles innervated by major motor nerves originating in the Lumbar and Sacral plexuses will be examined. The investigators will test patient's ability to perform the motor tasks below, using a 6-point Oxford scale (0 represents no muscle movement and 5 corresponds to normal strength): hip abduction, straight leg raise, heel slide, knee extension (while supporting the knee under the popliteal fossa), foot plantar flexion, foot dorsal flexion.
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 interventionThe Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain (0- no pain; 10- the worst pain imaginable). The investigators will record pain score at rest at the specified time intervals; except at 6 hours after intervention (block sited), when the pain score will be recorded simultaneously with hip range of motion assessment
Length of Stay in Recovery areaExpected 30 minutes to 3 hoursLength of Stay in Recovery area in minutes
The incidence of nausea and/or vomiting48 hoursThe incidence of nausea and/or vomiting (the total number recorded)
Patient satisfaction with anaesthesiaup to 6 daysPatient satisfaction with anaesthesia data will be collected on discharge from hospital on a scale of 0-4 (0=very dissatisfied, 4= very satisfied)
Overall patient satisfactionup to 6 daysOverall patient satisfaction data will be collected on discharge from hospital on a scale of 0-4 (0=very dissatisfied, 4= very satisfied)
Total operation timeDuring the expected duration of anaesthesia and surgery, which is on average 3 hoursStart to end of the recorded anaesthesia time (that includes the operation time)

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026