HumansPhase 4MORFICUSNCT03846102
MORphine Use in the Fascia Iliaca Compartment Block With UltraSound
A Phase 4 study testing Levobupivacaine, Acetaminophen and Morphine in people with Humans and Anesthetics, Local, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
Appropriate management of analgesia for proximal femoral fractures is a common problem in the emergency department (ED). Side effects from morphine usage such as nausea, vomiting, respiratory depression, sedation, and obstipation are especially pronounced in elderly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Humans, Anesthetics, Local, Morphine
- What is being tested?
- Levobupivacaine, Acetaminophen and Morphine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Jan 2019to 18 Feb 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient diagnosed with a proximal femoral fracture (femoral neck, trochanteric and sub trochanteric femoral fracture) upon arrival at the ED.
Who cannot join
- No informed consent patient
- Skin infection at injection site(s)
- Morphine allergy
- Levobupivacaïne allergy
- Operation within an hour after admission
- Inability to understand and quantify pain on a NRS
Show all 20Show fewer
- History of dementia
- Neurological deficit of fractured leg upon arrival at the ED
- Trauma with multiple fractures (more than 1)
- Risk of compartment syndrome of ipsilateral lower leg
- Proximal femoral fracture with other definitive treatment than operation
- Transfer to another hospital
- Actual morphine use
- Distracting pain in other location than hip
- Pregnancy
- No physician/nurse available for procedure.
- BMI > 40
- Saturation < 90%
- Previously unreported hypotension (systolic blood pressure < 100 mmHg)
- ASA IV or higher
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Zuyderland Medisch Centrum
Heerlen, Zuid Limburg, 6419PC
About this study
Appropriate management of analgesia for proximal femoral fractures is a common problem in the emergency department (ED). Side effects from morphine usage such as nausea, vomiting, respiratory depression, sedation, and obstipation are especially pronounced in elderly. Fascia Iliaca Compartment Block (FICB) holds promise as a simple and safe, and effective alternative method to reduce pain. Local anaesthetic injected in the anatomic space underlying the fascia iliaca, spreads to block the nerves traversing it. This regional anaesthesia includes the femoral nerve. Previous studies in the ED showed promise but lacked blinding, involved low numbers of subjects, or did not use ultrasound localisation of the injection site. The latter is becoming common practice. In this randomised placebo controlled trial the FICB with ultrasound localisation of injection of levobupivacaïne will be compared to the FICB with placebo. It aims to prove that less morphine is used in the intervention group. Other research parameters are pain scores and minor adverse events related to morphine use.
Read the detailed description
Proximal femoral fractures are common in the ED. A major challenge in such subjects is pain management. Suboptimal pain control is associated with stress, a prolonged hospital stay and delirium. Pain or fear of pain can limit early mobilisation, an important goal in treatment. Therefore early pain management is essential. Standard analgesic care consists of acetaminophen, opiates and/or Non-steroidal anti-inflammatory drugs (NSAID's). Opiates can cause respiratory depression, constipation, drowsiness, nausea and vomiting. Especially elderly patients are at risk for these side effects Regional nerve blocks are increasingly being adopted as an alternative pain management to systemic analgesia in the ED. One of such is the Fascia Iliaca Compartment Block (FICB). This is safe and simple to perform. Results from studies, despite lacking ultrasound guidance are promising. No permanent disability resulted from the few minor complications that have been reported. These include bladder perforation, pneumoretroperitoneum and neuropathy of the femoral nerve. Furthermore no additional treatment was necessary. Ultrasound prevents occurrence of such complications.
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
- Humans, Anesthetics, Local, Morphine, Pain Management, Analgesia, Pain
- Being tested
- Levobupivacaine, Placebo, Acetaminophen, Morphine, Fascia Iliaca Compartment Block with Levobupivacaine
- Keywords
- Fascia Iliaca Compartment Block, Peripheral Nerve Block, Elderly, Hip fracture, Levobupivacaïne, Morphine, Emergency Physician, Emergency department, Ultrasound, Pain score, Numerical Rating scale
- Medical subject headings
- Agnosia, Pain, Femoral Fractures, Hip Fractures, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Also called Chirocaïne, Levobupivacaine Hydrochloride
Levobupivacaïne for injection 7.5 mg/kg diluted with Sodium Chloride 0,9%
PlaceboDrug
Also called Placebo (for levobupivacaïne)
Sodium Chloride 0,9% for injection/infusion.
AcetaminophenDrug
Also called Paracetamol
Acetaminophen 500 milligram tablet
MorphineDrug
Also called Morphine hydrochloride
Morphine 1 mg/ml solution for infusion.
Fascia Iliaca Compartment Block with LevobupivacaineProcedure or surgery
Also called Fascia Iliaca Compartment Block, FIC Block
Ultrasound guided Fascia Iliaca Compartment Block with levobupivacaine placed in the emergency department by an emergency physician.
Fascia Iliaca Compartment Block with placeboProcedure or surgery
Also called Fascia Iliaca Compartment Block, FIC Block
Ultrasound guided Fascia Iliaca Compartment Block with placebo placed in the emergency department by an emergency physician.
| Study group | Role | What they receive |
|---|---|---|
| Levobupivacaïne | Experimental | 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. Receives: Drug: Levobupivacaine; Drug: Acetaminophen; Drug: Morphine; Procedure: Fascia Iliaca Compartment Block with Levobupivacaine |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo; Drug: Acetaminophen; Drug: Morphine; Procedure: Fascia Iliaca Compartment Block with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean morphine consumption in milligrams per hour with PCA pump, extracted from PCA-pump memory (mg / hour).
The primary objective is to assess if ultrasound guided FICB with levobupivacaïne results in reduced morphine consumption in ED patients with a proximal femoral fracture at six hours after FICB placement. The morphine consumption will be extracted from the memory from the PCA pump.
Measured: From FICB placement up to 6 hours.
Secondary outcomes (10)
Morphine consumption in milligrams per hour at each hour in the time preceding operation. (mg / hour)
To assess if there is a difference in morphine consumption at different time points in the time until operation. Data will be extracted from PCA pump memory.
Measured: Time from FICB placement until operation, up to 24 hours. Time point: each hour
Average of PCA-pump requests for morphine per hour (presses / hour)
The amount of times per hour a patient presses the PCA-pump to receive a bolus of morphine preoperatively.
Measured: Time from FICB placement until operation, up to 24 hours. Time point: each hour
Average time to first morphine administration with PCA-pump (minutes)
Average time until patient requests first morphine dose by pressing PCA-pump button.
Measured: Time from FICB placement until operation, up to 24 hours.
Average pain score at different time points.
Pain scores will be reported with the Numerical Rating Scale (NRS). The NRS is a 11 point scale that is used in the hospital pain protocol. 0 equals to no pain at all, 10 is the worst pain one can imagine. It is regarded as a reliable instrument for pain assessment in patients. Patients will be asked to keep track of their pain score at different time points, starting after FICB placement. They will be asked to report their pain score hourly until 22.00h and from 7.00h the next day. The pain scores will be measured with a dedicated android application, with which patients are asked to self-report their hourly pain scores. When patients are asleep no NRS will be recorded, unless they are awake. Also nurses will report pain scores following their normal rounds when changing shifts. A sleeping patient will be regarded as having a low pain score.
Measured: Time from FICB placement until operation, up to 24 hours. Time point: each hour
Difference in pain scores at movement.
The ED or ward nurse will ask and record the NRS when mobilising patients when necessary. Such situations include for example: bedpan for micturition or stools and bed to bed transfer. The recorded data will include time point, situation and NRS.
Pain scores will be reported with the Numerical Rating Scale (NRS). The NRS is a 11 point scale that is used in the hospital pain protocol. 0 equals to no pain at all, 10 is the worst pain one can imagine.
Measured: Time from FICB placement until operation, up to 24 hours. Time point: each hour
Patients with occurence of NRS > 3.
The number of patient with a NRS > 3, recorded by the patient in the preoperative time.
Measured: Time from FICB placement until operation, up to 24 hours. Time point at 24 hours.
Number of patients with a delirium in preoperative period.
The Delirium Observation Screening (DOS) scale is a validated screening tool for detecting delirium in hospitalised patients. In this hospital the DOS scale is routinely screened three times daily by ward nurses. The DOS will also be reported for participating patients in the preoperative period. Subjects with a reported DOS of ≥ 3 are regarded as being at high risk for having a delirium.
Measured: Time from FICB placement until operation, up to 24 hours. Time point at 24 hours.
The number of patients with morphine related side effects.
A patient will be regarded of having a side effect of morphine in case of any of the following:
- Occurrence of nausea
- Occurrence of vomiting
- Administration of antiemetic medication
- Episode of respiratory depression (< 10 breaths/minute)
- Episode of new hypoxia (SaO2 < 90 % )
- Administration of naloxone, which will be registered by the nurse on the CRF.
- Episodes of new hypotension. In this trial hypotension is defined as a systolic blood pressure <90 mmHg, mean arterial pressure <60 mmHg or a drop in systolic blood pressure >40 mmHg.
- Sedation score > 1. This wil be reported by the nurse with the Pasero Opioïd Induced Sedation Scale, as is prescribed by hospital protocol. S = normal sleep, 1 = drowsy but easy to rouse, 2 = sedated and difficult to rouse, and 3 = unconscious).
Measured: This will be assessed by the nurse at the rounds each shift up to 3 times daily until operation or up to 24 hours.
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0.
Adverse events relating to the fascia iliaca compartment block or morphine use will be reported.
Measured: Time from FICB placement until operation, up to 24 hours.
Time spent on FICB placement in seconds.
The duration of ultrasound guided FICB placement will be measured.
Measured: The time from needle entering patient, until procedure is terminated by the emergency physician.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start28 Jan 2019
- Primary completion18 Feb 2020
- Study completion18 Feb 2020
Why it stopped: COVID-19 crisis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for HumansStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blinded randomized placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Kabi
- Responsible party
- Sponsor
- Investigators
- Sanne Postma, MD, Principal investigator, Zuyderland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846102
- Sponsor's protocol ID
- NL60104.096.16
- Other IDs
- 2016-004698-42, 16T215, 2016
- Acronym
- MORFICUS
- Status last verified
- May 2021
- First submitted
- 7 Feb 2019
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9862240Cherny 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.
PubMed 11331334Chau 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.
PubMed 18686750Wheeler 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.
PubMed 14622770Groot 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.
PubMed 26759680Ritcey 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.
PubMed 26330019Kearns 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.
PubMed 27714758Birnbaum 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.
PubMed 22506940Walder 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.
PubMed 11472277Auroy 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.
PubMed 12411815Blackford 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.
PubMed 19157368Atchabahian 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.
PubMed 11374619Shelley 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.
PubMed 17138203Barrington 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.
PubMed 23788067Morrison 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.
PubMed 27787895
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MORphine Use in the Fascia Iliaca Compartment Block With UltraSound
- ClinicalTrials.gov ID
- NCT03846102
- Acronym / sponsor ID
- MORFICUS / NL60104.096.16
- Conditions
- Humans, Anesthetics, Local, Morphine, Pain Management, Analgesia, Pain
- Keywords
- Fascia Iliaca Compartment Block, Peripheral Nerve Block, Elderly, Hip fracture, Levobupivacaïne, Morphine, Emergency Physician, Emergency department
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 crisis.
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Collaborators
- Fresenius Kabi
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Appropriate management of analgesia for proximal femoral fractures is a common problem in the emergency department (ED). Side effects from morphine usage such as nausea, vomiting, respiratory depression, sedation, and obstipation are especially pronounced in elderly. Fascia Iliaca Compartment Block (FICB) holds promise as a simple and safe, and effective alternative method to reduce pain. Local anaesthetic injected in the anatomic space underlying the fascia iliaca, spreads to block the nerves traversing it. This regional anaesthesia includes the femoral nerve. Previous studies in the ED showed promise but lacked blinding, involved low numbers of subjects, or did not use ultrasound localisation of the injection site. The latter is becoming common practice. In this randomised placebo controlled trial the FICB with ultrasound localisation of injection of levobupivacaïne will be compared to the FICB with placebo. It aims to prove that less morphine is used in the intervention group. Other research parameters are pain scores and minor adverse events related to morphine use.
Detailed description
Proximal femoral fractures are common in the ED. A major challenge in such subjects is pain management. Suboptimal pain control is associated with stress, a prolonged hospital stay and delirium. Pain or fear of pain can limit early mobilisation, an important goal in treatment. Therefore early pain management is essential. Standard analgesic care consists of acetaminophen, opiates and/or Non-steroidal anti-inflammatory drugs (NSAID's). Opiates can cause respiratory depression, constipation, drowsiness, nausea and vomiting. Especially elderly patients are at risk for these side effects Regional nerve blocks are increasingly being adopted as an alternative pain management to systemic analgesia in the ED. One of such is the Fascia Iliaca Compartment Block (FICB). This is safe and simple to perform. Results from studies, despite lacking ultrasound guidance are promising. No permanent disability resulted from the few minor complications that have been reported. These include bladder perforation, pneumoretroperitoneum and neuropathy of the femoral nerve. Furthermore no additional treatment was necessary. Ultrasound prevents occurrence of such complications.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blinded randomized placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Levobupivacaïne | Experimental | Drug: Levobupivacaine, Drug: Acetaminophen, Drug: Morphine, Procedure: Fascia Iliaca Compartment Block with LevobupivacaineFascia 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. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Acetaminophen, Drug: Morphine, Procedure: Fascia Iliaca Compartment Block with placeboFascia 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient diagnosed with a proximal femoral fracture (femoral neck, trochanteric and sub trochanteric femoral fracture) upon arrival at the ED.
Key exclusion criteria (20 listed)
- No informed consent patient
- Skin infection at injection site(s)
- Morphine allergy
- Levobupivacaïne allergy
- Operation within an hour after admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevobupivacaineAlso: Chirocaïne, Levobupivacaine HydrochlorideLevobupivacaïne for injection 7.5 mg/kg diluted with Sodium Chloride 0,9% | Drug | Levobupivacaïne |
| PlaceboAlso: Placebo (for levobupivacaïne)Sodium Chloride 0,9% for injection/infusion. | Drug | Placebo |
| AcetaminophenAlso: ParacetamolAcetaminophen 500 milligram tablet | Drug | Levobupivacaïne, Placebo |
| MorphineAlso: Morphine hydrochlorideMorphine 1 mg/ml solution for infusion. | Drug | Levobupivacaïne, Placebo |
| Fascia Iliaca Compartment Block with LevobupivacaineAlso: Fascia Iliaca Compartment Block, FIC BlockUltrasound guided Fascia Iliaca Compartment Block with levobupivacaine placed in the emergency department by an emergency physician. | Procedure or surgery | Levobupivacaïne |
| Fascia Iliaca Compartment Block with placeboAlso: Fascia Iliaca Compartment Block, FIC BlockUltrasound guided Fascia Iliaca Compartment Block with placebo placed in the emergency department by an emergency physician. | Procedure or surgery | Placebo |
Primary outcome
Mean morphine consumption in milligrams per hour with PCA pump, extracted from PCA-pump memory (mg / hour).
Time frame: From FICB placement up to 6 hours.
The primary objective is to assess if ultrasound guided FICB with levobupivacaïne results in reduced morphine consumption in ED patients with a proximal femoral fracture at six hours after FICB placement. The morphine consumption will be extracted from the memory from the PCA pump.
10 secondary outcomes
Morphine consumption in milligrams per hour at each hour in the time preceding operation. (mg / hour)
Time frame: Time from FICB placement until operation, up to 24 hours. Time point: each hour
Average of PCA-pump requests for morphine per hour (presses / hour)
Time frame: Time from FICB placement until operation, up to 24 hours. Time point: each hour
Average time to first morphine administration with PCA-pump (minutes)
Time frame: Time from FICB placement until operation, up to 24 hours.
Average pain score at different time points.
Time frame: Time from FICB placement until operation, up to 24 hours. Time point: each hour
Difference in pain scores at movement.
Time frame: Time from FICB placement until operation, up to 24 hours. Time point: each hour
Patients with occurence of NRS > 3.
Time frame: Time from FICB placement until operation, up to 24 hours. Time point at 24 hours.
Number of patients with a delirium in preoperative period.
Time frame: Time from FICB placement until operation, up to 24 hours. Time point at 24 hours.
The number of patients with morphine related side effects.
Time frame: This will be assessed by the nurse at the rounds each shift up to 3 times daily until operation or up to 24 hours.
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: Time from FICB placement until operation, up to 24 hours.
Time spent on FICB placement in seconds.
Time frame: The time from needle entering patient, until procedure is terminated by the emergency physician.
Results and safety
The study was stopped early (reason given: COVID-19 crisis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Results publication: PubMed 9862240Hughes 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.
- Results publication: PubMed 11331334Cherny 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.
- Results publication: PubMed 18686750Chau 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.
- Results publication: PubMed 14622770Wheeler 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.
- Results publication: PubMed 26759680Groot 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.
- Results publication: PubMed 26330019Ritcey 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.
- Results publication: PubMed 27714758Kearns 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.
- Results publication: PubMed 22506940Birnbaum 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.
- Results publication: PubMed 11472277Walder 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.
- Results publication: PubMed 12411815Auroy 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.
- Results publication: PubMed 19157368Blackford 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.
- Results publication: PubMed 11374619Atchabahian 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.
- Guideline anticoagluants and regional anestesia and peripheral nerve blocks of the Dutch Society of AnesthesiologyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanne Postma, MD principal investigator
Zuyderland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levobupivacaine, Acetaminophen and Morphine in people with Humans and Anesthetics, Local, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: COVID-19 crisis.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean morphine consumption in milligrams per hour with PCA pump, extracted from PCA-pump memory (mg / hour). (time frame: From FICB placement up to 6 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03846102, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.