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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumbar plexus block | Active Comparator | Patients randomized to receive an ultrasound-guided lumbar plexus block |
|
| Suprainguinal fascia iliaca block | Experimental | Patients randomized to receive an ultrasound-guided suprainguinal fascia iliaca block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption over 24 hours | Total morphine consumption over 24 hours post block | 24 hours post block |
| Measure | Description | Time Frame |
|---|---|---|
| Performance time | Interval between the start of skin disinfection and the end of local anesthetic injection | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniela Bravo, MD | University of Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnico Universidad de Chile | Santiago | Santiago Metropolitan | 8380456 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17961837 | Background | Siddiqui ZI, Cepeda MS, Denman W, Schumann R, Carr DB. Continuous lumbar plexus block provides improved analgesia with fewer side effects compared with systemic opioids after hip arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):393-8. doi: 10.1016/j.rapm.2007.04.008. | |
| 9416746 | Background |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D059787 | Acute Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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 |
|
| 2 hours after surgery |
| Postoperative static pain at 3 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 3 hours after the block |
| Postoperative static pain at 6 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 6 hours after the block |
| Postoperative static pain at 12 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 12 hours after the block |
| Postoperative static pain at 24 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 24 hours after the block |
| Postoperative dynamic pain at 3 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 3 hours after the block |
| Postoperative dynamic pain at 6 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 6 hours after the block |
| Postoperative dynamic pain at 12 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 12 hours after the block |
| Postoperative dynamic pain at 24 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 24 hours after the block |
| Postoperative static pain at 48 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 48 hours after the block |
| Postoperative dynamic pain at 48 hours after block | Pain evaluated in Numeric Rating Score from 0 to 10 points | 48 hours after the block |
| Time until first morphine demand | Time until first patient-controlled analgesia morphine demand | 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. | 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. | 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. | 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) | 3 hours after block |
| Incidence of opioid related adverse events | Incidence of adverse events related to opioid use (nausea/vomiting, pruritus, somnolence, respiratory depression) | 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. | 24 hours after the block |
| Surgical duration | Time between skin incision and closure | 4 hours |
| Readiness to discharge | Days to be ready for discharge following physiotherapist criteria | 4 days after surgery |
| Length of hospital stay | Length of hospital stay after surgery | 7 days after surgery |
| Klein SM, D'Ercole F, Greengrass RA, Warner DS. Enoxaparin associated with psoas hematoma and lumbar plexopathy after lumbar plexus block. Anesthesiology. 1997 Dec;87(6):1576-9. doi: 10.1097/00000542-199712000-00040. No abstract available. |
| 8602680 | Background | Aida S, Takahashi H, Shimoji K. Renal subcapsular hematoma after lumbar plexus block. Anesthesiology. 1996 Feb;84(2):452-5. doi: 10.1097/00000542-199602000-00027. No abstract available. |
| 15321930 | Background | Aveline C, Bonnet F. Delayed retroperitoneal haematoma after failed lumbar plexus block. Br J Anaesth. 2004 Oct;93(4):589-91. doi: 10.1093/bja/aeh242. Epub 2004 Aug 20. |
| 12552223 | Background | Weller RS, Gerancher JC, Crews JC, Wade KL. Extensive retroperitoneal hematoma without neurologic deficit in two patients who underwent lumbar plexus block and were later anticoagulated. Anesthesiology. 2003 Feb;98(2):581-5. doi: 10.1097/00000542-200302000-00044. No abstract available. |
| 9750813 | Background | Gentili M, Aveline C, Bonnet F. [Total spinal anesthesia after posterior lumbar plexus block]. Ann Fr Anesth Reanim. 1998;17(7):740-2. doi: 10.1016/s0750-7658(98)80112-3. French. |
| 12717153 | Background | Pousman RM, Mansoor Z, Sciard D. Total spinal anesthetic after continuous posterior lumbar plexus block. Anesthesiology. 2003 May;98(5):1281-2. doi: 10.1097/00000542-200305000-00034. No abstract available. |
| 19468598 | Background | Duarte LT, Saraiva RA. [Total spinal block after posterior lumbar plexus blockade: case report.]. Rev Bras Anestesiol. 2006 Oct;56(5):518-23. doi: 10.1590/s0034-70942006000500010. Portuguese. |
| 24794455 | Background | Dogan Z, Bakan M, Idin K, Esen A, Uslu FB, Ozturk E. Total spinal block after lumbar plexus block: a case report. Braz J Anesthesiol. 2014 Mar-Apr;64(2):121-3. doi: 10.1016/j.bjane.2013.03.002. Epub 2013 Oct 11. |
| 18813048 | Background | Gadsden JC, Lindenmuth DM, Hadzic A, Xu D, Somasundarum L, Flisinski KA. Lumbar plexus block using high-pressure injection leads to contralateral and epidural spread. Anesthesiology. 2008 Oct;109(4):683-8. doi: 10.1097/ALN.0b013e31818631a7. |
| 12411815 | Background | Auroy Y, Benhamou D, Bargues L, Ecoffey C, Falissard B, Mercier FJ, Bouaziz H, Samii K. Major complications of regional anesthesia in France: The SOS Regional Anesthesia Hotline Service. Anesthesiology. 2002 Nov;97(5):1274-80. doi: 10.1097/00000542-200211000-00034. |
| 2589650 | Background | Dalens B, Vanneuville G, Tanguy A. Comparison of the fascia iliaca compartment block with the 3-in-1 block in children. Anesth Analg. 1989 Dec;69(6):705-13. |
| 19258967 | Background | Dolan J, Williams A, Murney E, Smith M, Kenny GN. Ultrasound guided fascia iliaca block: a comparison with the loss of resistance technique. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):526-31. doi: 10.1016/j.rapm.2008.03.008. |
| 26767235 | Background | Kumar K, Pandey RK, Bhalla AP, Kashyap L, Garg R, Darlong V, Malhotra R, Yadav CS. Comparison of conventional infrainguinal versus modified proximal suprainguinal approach of Fascia Iliaca Compartment Block for postoperative analgesia in Total Hip Arthroplasty. A prospective randomized study. Acta Anaesthesiol Belg. 2015;66(3):95-100. |
| 21401544 | Background | Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24. |
| 28059869 | Background | Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543. |
| 26426575 | Background | Sauter AR, Ullensvang K, Niemi G, Lorentzen HT, Bendtsen TF, Borglum J, Pripp AH, Romundstad L. The Shamrock lumbar plexus block: A dose-finding study. Eur J Anaesthesiol. 2015 Nov;32(11):764-70. doi: 10.1097/EJA.0000000000000265. |
| 29135692 | Background | Arnuntasupakul V, Chalachewa T, Leurcharusmee P, Tiyaprasertkul W, Finlayson RJ, Tran DQ. Ultrasound with neurostimulation compared with ultrasound guidance alone for lumbar plexus block: A randomised single blinded equivalence trial. Eur J Anaesthesiol. 2018 Mar;35(3):224-230. doi: 10.1097/EJA.0000000000000736. |
| D012216 |
| Rheumatic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |