Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744065
• Other study ID #: OAIC1001/18
• Status: Completed
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: January 23, 2020

Study information

• Verified date: June 2020
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 23, 2020
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Hip Osteoarthritis
• Opioid Use
• Osteoarthritis, Hip
• Pain, Acute
• Pain, Postoperative

Intervention

Procedure:
• lumbar plexus 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
• 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, underneath the fascia iliaca at the suprainguinal level

Locations

Country	Name	City	State
Chile	Hospital Clínico Universidad de Chile	Santiago	Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (18)

Aida S, Takahashi H, Shimoji K. Renal subcapsular hematoma after lumbar plexus block. Anesthesiology. 1996 Feb;84(2):452-5. — View Citation

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. — View Citation

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. Erratum in: Anesthesiology. 2003 Feb;98(2):595. Mercier Frédéric [corrected to Mercier Frédéric J]. — View Citation

Aveline C, Bonnet F. Delayed retroperitoneal haematoma after failed lumbar plexus block. Br J Anaesth. 2004 Oct;93(4):589-91. Epub 2004 Aug 20. — View Citation

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. Erratum in: Anesth Analg 1990 Apr;70(4):474. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Duarte LT, Saraiva RA. [Total spinal block after posterior lumbar plexus blockade: case report.]. Rev Bras Anestesiol. 2006 Oct;56(5):518-23. Portuguese. — View Citation

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. — View Citation

Gentili M, Aveline C, Bonnet F. [Total spinal anesthesia after posterior lumbar plexus block]. Ann Fr Anesth Reanim. 1998;17(7):740-2. French. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Pousman RM, Mansoor Z, Sciard D. Total spinal anesthetic after continuous posterior lumbar plexus block. Anesthesiology. 2003 May;98(5):1281-2. — View Citation

Sauter AR, Ullensvang K, Niemi G, Lorentzen HT, Bendtsen TF, Børglum 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption over 24 hours	Total morphine consumption over 24 hours post block	24 hours post block
Secondary	Performance time	Interval between the start of skin disinfection and the end of local anesthetic injection	2 hours after surgery
Secondary	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	2 hours after surgery
Secondary	Postoperative static pain at 3 hours after block	Pain evaluated in Numeric Rating Score from 0 to 10 points	3 hours after the block
Secondary	Postoperative static pain at 6 hours after block	Pain evaluated in Numeric Rating Score from 0 to 10 points	6 hours after the block
Secondary	Postoperative static pain at 12 hours after block	Pain evaluated in Numeric Rating Score from 0 to 10 points	12 hours after the block
Secondary	Postoperative static pain at 24 hours after block	Pain evaluated in Numeric Rating Score from 0 to 10 points	24 hours after the block
Secondary	Postoperative dynamic pain at 3 hours after block	Pain evaluated in Numeric Rating Score from 0 to 10 points	3 hours after the block
Secondary	Postoperative dynamic pain at 6 hours after block	Pain evaluated in Numeric Rating Score from 0 to 10 points	6 hours after the block
Secondary	Postoperative dynamic pain at 12 hours after block	Pain evaluated in Numeric Rating Score from 0 to 10 points	12 hours after the block
Secondary	Postoperative dynamic pain at 24 hours after block	Pain evaluated in Numeric Rating Score from 0 to 10 points	24 hours after the block
Secondary	Postoperative static pain at 48 hours after block	Pain evaluated in Numeric Rating Score from 0 to 10 points	48 hours after the block
Secondary	Postoperative dynamic pain at 48 hours after block	Pain evaluated in Numeric Rating Score from 0 to 10 points	48 hours after the block
Secondary	Time until first morphine demand	Time until first patient-controlled analgesia morphine demand	48 hours after the block
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of opioid related adverse events	Incidence of adverse events related to opioid use (nausea/vomiting, pruritus, somnolence, respiratory depression)	48 hours after block
Secondary	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
Secondary	Surgical duration	Time between skin incision and closure	4 hours
Secondary	Readiness to discharge	Days to be ready for discharge following physiotherapist criteria	4 days after surgery
Secondary	Length of hospital stay	Length of hospital stay after surgery	7 days after surgery