Clinical trial NCT03744065: Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement
Official title: A Randomized Comparison Between Ultrasound Guided Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Pain, Acute
Pain, Postoperative
Opioid Use
Keywords: nerve block
fascia iliaca
hip replacement
lumbar plexus
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The nerves from lumbar plexus (LP) are the current target to achieve analgesia after a total hip arthroplasty (THA). Lumbar plexus block (LPB) is an alternative that provides optimal postoperative analgesia. However, many adverse effects and complications have been reported due to its proximity to vital structures. Because of these shortcomings, an alternative to block the LP nerves is required.

In a recent trial suprainguinal Fascia Iliaca Block (SFIB) was reported to provide reliable analgesia in THA. SFIB may carry a lower risk profile, however, no study has compared the efficacy of LPB and SFIB in this setting.

Thus, this randomized trial is set out to compare US guided LPB and SFIB for analgesia after THA. The hypothesis is that both blocks would result in similar postoperative opioid (morphine) consumption at 24 hours and, therefore, designed the study as an equivalence trial.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years
* American Society of Anesthesiologists classification 1-3
* Body mass index between 20 and 35 (kg/m2)

Exclusion Criteria:

* Adults who are unable to give their own consent
* Pre-existing neuropathy (assessed by history and physical examination)
* Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
* Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
* Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
* Allergy to local anesthetics (LAs) or morphine
* Pregnancy
* Prior surgery in the corresponding side of the lumbar o suprainguinal area
* Chronic pain syndromes requiring opioid intake at home

Primary outcomes:
measure: Morphine consumption over 24 hours
timeFrame: 24 hours post block
Secondary outcomes:
measure: Performance time
timeFrame: 2 hours after surgery
measure: Number of needle passes
timeFrame: 2 hours after surgery
measure: Postoperative static pain at 3 hours after block
timeFrame: 3 hours after the block
measure: Postoperative static pain at 6 hours after block
timeFrame: 6 hours after the block
measure: Postoperative static pain at 12 hours after block
timeFrame: 12 hours after the block
measure: Postoperative static pain at 24 hours after block
timeFrame: 24 hours after the block
measure: Postoperative dynamic pain at 3 hours after block
timeFrame: 3 hours after the block
measure: Postoperative dynamic pain at 6 hours after block
timeFrame: 6 hours after the block
measure: Postoperative dynamic pain at 12 hours after block
timeFrame: 12 hours after the block
measure: Postoperative dynamic pain at 24 hours after block
timeFrame: 24 hours after the block
measure: Postoperative static pain at 48 hours after block
timeFrame: 48 hours after the block
measure: Postoperative dynamic pain at 48 hours after block
timeFrame: 48 hours after the block
measure: Time until first morphine demand
timeFrame: 48 hours after the block
measure: Block assessment at 3 hours
timeFrame: 3 hours after the block
measure: Block assessment at 6 hours
timeFrame: 6 hours after the block
measure: Block assessment at 24 hours
timeFrame: 24 hours after the block
measure: Incidence of block related adverse events
timeFrame: 3 hours after block
measure: Incidence of opioid related adverse events
timeFrame: 48 hours after block
measure: Incidence of Inability to perform physiotherapy
timeFrame: 24 hours after the block
measure: Surgical duration
timeFrame: 4 hours
measure: Readiness to discharge
timeFrame: 4 days after surgery
measure: Length of hospital stay
timeFrame: 7 days after surgery
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
state: Metropolitana
Study officials:
affiliation: University of Chile
name: Daniela Bravo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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