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Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement

U

University of Chile

Status

Completed

Conditions

Hip Osteoarthritis
Pain, Acute
Pain, Postoperative
Opioid Use

Treatments

Procedure: suprainguinal fascia iliaca block
Procedure: lumbar plexus block

Study type

Interventional

Funder types

Other

Identifiers

NCT03744065
OAIC1001/18

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Lumbar plexus block
Active Comparator group
Description:
Patients randomized to receive an ultrasound-guided lumbar plexus block
Treatment:
Procedure: lumbar plexus block
Suprainguinal fascia iliaca block
Experimental group
Description:
Patients randomized to receive an ultrasound-guided suprainguinal fascia iliaca block
Treatment:
Procedure: suprainguinal fascia iliaca block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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