MORphine Use in the Fascia Iliaca Compartment Block With UltraSound
NCT ID: NCT03846102
Last Updated: 2021-05-06
Study Results
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Basic Information
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TERMINATED
PHASE4
55 participants
INTERVENTIONAL
2019-01-28
2020-02-18
Brief Summary
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Detailed Description
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The studies that have compared this specific block to standard analgesia have shown that regional anaesthesia may be superior. However these studies have low inclusion numbers and lack of randomisation and/or blinding.. Literature up until now has used the numerical rating scale (NRS) as a primary outcome. Although the NRS is a very trustworthy method of measuring pain, the score is a subjective outcome Morphine consumption on the other hand is more objective.
The FICB involves the anatomic space situated at the level of the groin in which important nerves that supply the hip joint lie. Anteriorly the space is covered by the iliac fascia. It is therefore known as the fascia iliaca compartment. By introducing a large volume of local anaesthetic solutions, the femoral, lateral femoral cutaneous and to a lesser extent the obturator nerve are anesthetized. Solutions can spread easily within the compartment. Therefore a safe position injection site can be chosen, minimizing the risk of intravascular injection and nerve damage. The classic position for injection is about 3 centimetres lateral from the femoral nerve. In the original FICB the injection site is determined by using landmarks. The fascia iliaca compartment is then approached by introducing a blunt needle, which enables the physician to feel a 'pop' twice. The first pop is felt when the fascia lata is pierced, the second when the fascia iliaca is passed.
Most ED's nowadays have access to ultrasound. When used for FICB placement, the local anaesthetic solution is visualized as it is introduced into the space. Therefore a higher chance of successful placement of agent and a lower risk of complications can be expected. So far no large double blind randomised placebo controlled trials have evaluated morphine use in ultrasound guided placement of local anaesthetic agents with FICB in the ED. This study is designed as such. Total morphine use will be taken as the primary outcome, administered in the form of patient controlled analgesia (PCA).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Levobupivacaïne
Fascia Iliaca Compartment Block with Levobupivacaine Hydrochloride (weight based dosage and volume)
Ideal Body Weight : Levobupivacaïne dose (mg) : Dose/kilogram (mg/kg) : Total volume (ml)
* \[\<64 kg : 100 mg : 2.0 mg/kg : 40 ml\]
* \[65-74 kg : 125 mg : 1.9 mg/kg : 45 ml\]
* \[≥ 75 kg : 150 mg : 2.0 mg/kg : 50 ml\]
Acetaminophen 1 gram (tablets) 4 times daily.
Patient Controlled Analgesia Pump with morphine 1 milligram per dose.
Levobupivacaine
Levobupivacaïne for injection 7.5 mg/kg diluted with Sodium Chloride 0,9%
Acetaminophen
Acetaminophen 500 milligram tablet
Morphine
Morphine 1 mg/ml solution for infusion.
Fascia Iliaca Compartment Block with Levobupivacaine
Ultrasound guided Fascia Iliaca Compartment Block with levobupivacaine placed in the emergency department by an emergency physician.
Placebo
Fascia Iliaca Compartment Block with placebo (Sodium Chloride 0.9%), similar volume to experimental arm.
Ideal Body Weight : Total volume (ml)
* \[\<64 kg : 40 ml\]
* \[65-74 kg : 45 ml\]
* \[≥ 75 kg : 50 ml\]
Acetaminophen 1 gram (tablets) 4 times daily.
Patient Controlled Analgesia Pump with morphine 1 milligram per dose.
Placebo
Sodium Chloride 0,9% for injection/infusion.
Acetaminophen
Acetaminophen 500 milligram tablet
Morphine
Morphine 1 mg/ml solution for infusion.
Fascia Iliaca Compartment Block with placebo
Ultrasound guided Fascia Iliaca Compartment Block with placebo placed in the emergency department by an emergency physician.
Interventions
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Levobupivacaine
Levobupivacaïne for injection 7.5 mg/kg diluted with Sodium Chloride 0,9%
Placebo
Sodium Chloride 0,9% for injection/infusion.
Acetaminophen
Acetaminophen 500 milligram tablet
Morphine
Morphine 1 mg/ml solution for infusion.
Fascia Iliaca Compartment Block with Levobupivacaine
Ultrasound guided Fascia Iliaca Compartment Block with levobupivacaine placed in the emergency department by an emergency physician.
Fascia Iliaca Compartment Block with placebo
Ultrasound guided Fascia Iliaca Compartment Block with placebo placed in the emergency department by an emergency physician.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Skin infection at injection site(s)
3. Morphine allergy
4. Levobupivacaïne allergy
5. Operation within an hour after admission
6. Inability to understand and quantify pain on a NRS
7. History of dementia
8. Neurological deficit of fractured leg upon arrival at the ED
9. Trauma with multiple fractures (more than 1)
10. Risk of compartment syndrome of ipsilateral lower leg
11. Proximal femoral fracture with other definitive treatment than operation
12. Transfer to another hospital
13. Actual morphine use
14. Distracting pain in other location than hip
15. Pregnancy
16. No physician/nurse available for procedure.
17. BMI \> 40
18. Saturation \< 90%
19. Previously unreported hypotension (systolic blood pressure \< 100 mmHg)
20. ASA IV or higher
18 Years
ALL
No
Sponsors
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Fresenius Kabi
INDUSTRY
Zuyderland Medisch Centrum
OTHER
Responsible Party
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Principal Investigators
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Sanne Postma, MD
Role: PRINCIPAL_INVESTIGATOR
Zuyderland Medical Center
Locations
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Zuyderland Medisch Centrum
Heerlen, Zuid Limburg, Netherlands
Countries
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References
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Hughes SG. Prescribing for the elderly patient: why do we need to exercise caution? Br J Clin Pharmacol. 1998 Dec;46(6):531-3. doi: 10.1046/j.1365-2125.1998.00842.x. No abstract available.
Cherny N, Ripamonti C, Pereira J, Davis C, Fallon M, McQuay H, Mercadante S, Pasternak G, Ventafridda V; Expert Working Group of the European Association of Palliative Care Network. Strategies to manage the adverse effects of oral morphine: an evidence-based report. J Clin Oncol. 2001 May 1;19(9):2542-54. doi: 10.1200/JCO.2001.19.9.2542.
Chau DL, Walker V, Pai L, Cho LM. Opiates and elderly: use and side effects. Clin Interv Aging. 2008;3(2):273-8. doi: 10.2147/cia.s1847.
Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80. doi: 10.1054/jpai.2002.123652. No abstract available.
Groot L, Dijksman LM, Simons MP, Zwartsenburg MM, Rebel JR. Single Fascia Iliaca Compartment Block is Safe and Effective for Emergency Pain Relief in Hip-fracture Patients. West J Emerg Med. 2015 Dec;16(7):1188-93. doi: 10.5811/westjem.2015.10.28270. Epub 2015 Dec 14.
Ritcey B, Pageau P, Woo MY, Perry JJ. Regional Nerve Blocks For Hip and Femoral Neck Fractures in the Emergency Department: A Systematic Review. CJEM. 2016 Jan;18(1):37-47. doi: 10.1017/cem.2015.75. Epub 2015 Sep 2.
Kearns R, Macfarlane A, Grant A, Puxty K, Harrison P, Shaw M, Anderson K, Kinsella J. A randomised, controlled, double blind, non-inferiority trial of ultrasound-guided fascia iliaca block vs. spinal morphine for analgesia after primary hip arthroplasty. Anaesthesia. 2016 Dec;71(12):1431-1440. doi: 10.1111/anae.13620. Epub 2016 Oct 7.
Birnbaum A, Schechter C, Tufaro V, Touger R, Gallagher EJ, Bijur P. Efficacy of patient-controlled analgesia for patients with acute abdominal pain in the emergency department: a randomized trial. Acad Emerg Med. 2012 Apr;19(4):370-7. doi: 10.1111/j.1553-2712.2012.01322.x.
Walder B, Schafer M, Henzi I, Tramer MR. Efficacy and safety of patient-controlled opioid analgesia for acute postoperative pain. A quantitative systematic review. Acta Anaesthesiol Scand. 2001 Aug;45(7):795-804. doi: 10.1034/j.1399-6576.2001.045007795.x.
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.
Blackford D, Westhoffen P. Accidental bladder puncture: a complication of a modified fascia iliaca block. Anaesth Intensive Care. 2009 Jan;37(1):140-1. No abstract available.
Atchabahian A, Brown AR. Postoperative neuropathy following fascia iliaca compartment blockade. Anesthesiology. 2001 Mar;94(3):534-6. doi: 10.1097/00000542-200103000-00029. No abstract available.
Shelley BG, Haldane GJ. Pneumoretroperitoneum as a consequence of fascia iliaca block. Reg Anesth Pain Med. 2006 Nov-Dec;31(6):582-3. doi: 10.1016/j.rapm.2006.08.009. No abstract available.
Barrington MJ, Kluger R. Ultrasound guidance reduces the risk of local anesthetic systemic toxicity following peripheral nerve blockade. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):289-99. doi: 10.1097/AAP.0b013e318292669b.
Morrison RS, Dickman E, Hwang U, Akhtar S, Ferguson T, Huang J, Jeng CL, Nelson BP, Rosenblatt MA, Silverstein JH, Strayer RJ, Torrillo TM, Todd KH. Regional Nerve Blocks Improve Pain and Functional Outcomes in Hip Fracture: A Randomized Controlled Trial. J Am Geriatr Soc. 2016 Dec;64(12):2433-2439. doi: 10.1111/jgs.14386. Epub 2016 Oct 27.
Morrison RS, Magaziner J, Gilbert M, Koval KJ, McLaughlin MA, Orosz G, Strauss E, Siu AL. Relationship between pain and opioid analgesics on the development of delirium following hip fracture. J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):76-81. doi: 10.1093/gerona/58.1.m76.
Rashid A, Beswick E, Galitzine S, Fitton L. Regional analgesia in the emergency department for hip fractures: survey of current UK practice and its impact on services in a teaching hospital. Emerg Med J. 2014 Nov;31(11):909-13. doi: 10.1136/emermed-2013-202794. Epub 2013 Jul 22.
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.
Hogh A, Dremstrup L, Jensen SS, Lindholt J. Fascia iliaca compartment block performed by junior registrars as a supplement to pre-operative analgesia for patients with hip fracture. Strategies Trauma Limb Reconstr. 2008 Sep;3(2):65-70. doi: 10.1007/s11751-008-0037-9. Epub 2008 Sep 2.
Revill SI, Robinson JO, Rosen M, Hogg MI. The reliability of a linear analogue for evaluating pain. Anaesthesia. 1976 Nov;31(9):1191-8. doi: 10.1111/j.1365-2044.1976.tb11971.x.
Abrahams MS, Aziz MF, Fu RF, Horn JL. Ultrasound guidance compared with electrical neurostimulation for peripheral nerve block: a systematic review and meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Mar;102(3):408-17. doi: 10.1093/bja/aen384. Epub 2009 Jan 26.
Huang JJ, Taguchi A, Hsu H, Andriole GL Jr, Kurz A. Preoperative oral rofecoxib does not decrease postoperative pain or morphine consumption in patients after radical prostatectomy: a prospective, randomized, double-blinded, placebo-controlled trial. J Clin Anesth. 2001 Mar;13(2):94-7. doi: 10.1016/s0952-8180(01)00219-7.
Mouzopoulos G, Vasiliadis G, Lasanianos N, Nikolaras G, Morakis E, Kaminaris M. Fascia iliaca block prophylaxis for hip fracture patients at risk for delirium: a randomized placebo-controlled study. J Orthop Traumatol. 2009 Sep;10(3):127-33. doi: 10.1007/s10195-009-0062-6. Epub 2009 Aug 19.
Petre BM, Roxbury CR, McCallum JR, Defontes KW 3rd, Belkoff SM, Mears SC. Pain reporting, opiate dosing, and the adverse effects of opiates after hip or knee replacement in patients 60 years old or older. Geriatr Orthop Surg Rehabil. 2012 Mar;3(1):3-7. doi: 10.1177/2151458511432758.
Fletcher AK, Rigby AS, Heyes FL. Three-in-one femoral nerve block as analgesia for fractured neck of femur in the emergency department: a randomized, controlled trial. Ann Emerg Med. 2003 Feb;41(2):227-33. doi: 10.1067/mem.2003.51.
Foss NB, Kristensen BB, Bundgaard M, Bak M, Heiring C, Virkelyst C, Hougaard S, Kehlet H. Fascia iliaca compartment blockade for acute pain control in hip fracture patients: a randomized, placebo-controlled trial. Anesthesiology. 2007 Apr;106(4):773-8. doi: 10.1097/01.anes.0000264764.56544.d2.
Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
Related Links
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Guideline anticoagluants and regional anestesia and peripheral nerve blocks of the Dutch Society of Anesthesiology
Other Identifiers
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2016-004698-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16T215
Identifier Type: OTHER
Identifier Source: secondary_id
NL60104.096.16
Identifier Type: -
Identifier Source: org_study_id
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