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Completed

NCT Number: NCT03744065

Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement

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.

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Key information

Conditions

Hip Osteoarthritis Acute Pain Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Opioid Use Osteoarthritis Osteoarthritis, Hip Pain Pain, Acute Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rheumatic Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Universidad de Chile

Santiago, Santiago Metropolitan, 8380456, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lumbar plexus block

Procedure

Injection with ultrasound guidance of 40 mL of levobupivacaine 0.25% with 5 micrograms of epinephrine per mL and dexamethasone 4 milligrams, in the posteromedial quadrant of psoas muscle

suprainguinal fascia iliaca block

Procedure

Injection with ultrasound guidance of 40 mL of levobupivacaine 0.25% with 5 micrograms of epinephrine per mL and dexamethasone 4 milligrams, underneath the fascia iliaca at the suprainguinal level

Primary outcomes

  1. Morphine consumption over 24 hours

    Time frame: 24 hours post block

    Total morphine consumption over 24 hours post block

Secondary outcomes

  1. Performance time

    Time frame: 2 hours after surgery

    Interval between the start of skin disinfection and the end of local anesthetic injection

  2. Number of needle passes

    Time frame: 2 hours after surgery

    The initial needle insertion counted as the first pass. Any subsequent needle advancement that is preceded by a retraction of at least 10 mm counts as an additional pass

  3. Postoperative static pain at 3 hours after block

    Time frame: 3 hours after the block

    Pain evaluated in Numeric Rating Score from 0 to 10 points

  4. Postoperative static pain at 6 hours after block

    Time frame: 6 hours after the block

    Pain evaluated in Numeric Rating Score from 0 to 10 points

  5. Postoperative static pain at 12 hours after block

    Time frame: 12 hours after the block

    Pain evaluated in Numeric Rating Score from 0 to 10 points

  6. Postoperative static pain at 24 hours after block

    Time frame: 24 hours after the block

    Pain evaluated in Numeric Rating Score from 0 to 10 points

  7. Postoperative dynamic pain at 3 hours after block

    Time frame: 3 hours after the block

    Pain evaluated in Numeric Rating Score from 0 to 10 points

  8. Postoperative dynamic pain at 6 hours after block

    Time frame: 6 hours after the block

    Pain evaluated in Numeric Rating Score from 0 to 10 points

  9. Postoperative dynamic pain at 12 hours after block

    Time frame: 12 hours after the block

    Pain evaluated in Numeric Rating Score from 0 to 10 points

  10. Postoperative dynamic pain at 24 hours after block

    Time frame: 24 hours after the block

    Pain evaluated in Numeric Rating Score from 0 to 10 points

  11. Postoperative static pain at 48 hours after block

    Time frame: 48 hours after the block

    Pain evaluated in Numeric Rating Score from 0 to 10 points

  12. Postoperative dynamic pain at 48 hours after block

    Time frame: 48 hours after the block

    Pain evaluated in Numeric Rating Score from 0 to 10 points

  13. Time until first morphine demand

    Time frame: 48 hours after the block

    Time until first patient-controlled analgesia morphine demand

  14. Block assessment at 3 hours

    Time frame: 3 hours after the block

    Sensorimotor block assessed using a 10-point composite score evaluating sensory block of the lateral femoral cutaneous, femoral and obturator nerves, and motor block of femoral and obturator nerves.

    Sensation will be assessed with ice on then lateral, anterior and medial thigh using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.

    Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.

  15. Block assessment at 6 hours

    Time frame: 6 hours after the block

    Sensorimotor block assessed using a 10-point composite score evaluating sensory block of the lateral femoral cutaneous, femoral and obturator nerves, and motor block of femoral and obturator nerves.

    Sensation will be assessed with ice on then lateral, anterior and medial thigh using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.

    Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.

  16. Block assessment at 24 hours

    Time frame: 24 hours after the block

    Sensorimotor block assessed using a 10-point composite score evaluating sensory block of the lateral femoral cutaneous, femoral and obturator nerves, and motor block of femoral and obturator nerves.

    Sensation will be assessed with ice on then lateral, anterior and medial thigh using a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, patient can feel touch but not cold; 2= anesthetic block, patient cannot feel cold or touch.

    Motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.

  17. Incidence of block related adverse events

    Time frame: 3 hours after block

    Incidence of adverse events related to nerve block (vascular puncture, local anesthetic systemic toxicity, epidural spread)

  18. Incidence of opioid related adverse events

    Time frame: 48 hours after block

    Incidence of adverse events related to opioid use (nausea/vomiting, pruritus, somnolence, respiratory depression)

  19. Incidence of Inability to perform physiotherapy

    Time frame: 24 hours after the block

    Inability to perform physiotherapy due to pain (score more than 4 in Numeric Rating Score from 0 to 10 points) or motor blockade.

  20. Surgical duration

    Time frame: 4 hours

    Time between skin incision and closure

  21. Readiness to discharge

    Time frame: 4 days after surgery

    Days to be ready for discharge following physiotherapist criteria

  22. Length of hospital stay

    Time frame: 7 days after surgery

    Length of hospital stay after surgery

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

A Randomized Comparison Between Ultrasound Guided Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement Analgesia

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 16, 2018
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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