An interventional study of lumbar plexus block and suprainguinal fascia iliaca block in Hip Osteoarthritis, Pain, Acute and Pain, Postoperative, sponsored by University of Chile. Completed at 1 site in Chile. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by University of Chile · Not applicable, Interventional, and Treatment
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.
628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.
This study's enrollment of 60 is below the median of 90 across 450 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →University of Chile is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients randomized to receive an ultrasound-guided lumbar plexus block
Procedure: lumbar plexus block
Patients randomized to receive an ultrasound-guided suprainguinal fascia iliaca block
Procedure: suprainguinal fascia iliaca block
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
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
Morphine consumption over 24 hours
Total morphine consumption over 24 hours post block
Time frame: 24 hours post block
Performance time
Interval between the start of skin disinfection and the end of local anesthetic injection
Time frame: 2 hours after surgery
Number of needle passes
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
Time frame: 2 hours after surgery
Postoperative static pain at 3 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time frame: 3 hours after the block
Postoperative static pain at 6 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time frame: 6 hours after the block
Postoperative static pain at 12 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time frame: 12 hours after the block
Postoperative static pain at 24 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time frame: 24 hours after the block
Postoperative dynamic pain at 3 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time frame: 3 hours after the block
Postoperative dynamic pain at 6 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time frame: 6 hours after the block
Postoperative dynamic pain at 12 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time frame: 12 hours after the block
Postoperative dynamic pain at 24 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time frame: 24 hours after the block
Postoperative static pain at 48 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time frame: 48 hours after the block
Postoperative dynamic pain at 48 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Time frame: 48 hours after the block
Time until first morphine demand
Time until first patient-controlled analgesia morphine demand
Time frame: 48 hours after the block
Block assessment at 3 hours
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.
Time frame: 3 hours after the block
Block assessment at 6 hours
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.
Time frame: 6 hours after the block
Block assessment at 24 hours
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.
Time frame: 24 hours after the block
Incidence of block related adverse events
Incidence of adverse events related to nerve block (vascular puncture, local anesthetic systemic toxicity, epidural spread)
Time frame: 3 hours after block
Incidence of opioid related adverse events
Incidence of adverse events related to opioid use (nausea/vomiting, pruritus, somnolence, respiratory depression)
Time frame: 48 hours after block
Incidence of Inability to perform physiotherapy
Inability to perform physiotherapy due to pain (score more than 4 in Numeric Rating Score from 0 to 10 points) or motor blockade.
Time frame: 24 hours after the block
Surgical duration
Time between skin incision and closure
Time frame: 4 hours
Readiness to discharge
Days to be ready for discharge following physiotherapist criteria
Time frame: 4 days after surgery
Length of hospital stay
Length of hospital stay after surgery
Time frame: 7 days after surgery
Plan to share: No
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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University of Chile