Hip OsteoarthritisNCT03744065
Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement
A study testing lumbar plexus block and suprainguinal fascia iliaca block in people with Hip Osteoarthritis and Pain, Acute, run by University of Chile at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hip Osteoarthritis, Pain, Acute, Pain, Postoperative
- What is being tested?
- lumbar plexus block and suprainguinal fascia iliaca block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChile
- Study dates
- 19 Nov 2018to 23 Jan 2020
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years
- American Society of Anesthesiologists classification 1-3
- Body mass index between 20 and 35 (kg/m2)
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy
- Prior surgery in the corresponding side of the lumbar o suprainguinal area
- Chronic pain syndromes requiring opioid intake at home
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Clínico Universidad de Chile
Santiago, Santiago Metropolitan, 8380456
About this study
Official title: A Randomized Comparison Between Ultrasound Guided Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement Analgesia
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.
- Conditions
- Hip Osteoarthritis, Pain, Acute, Pain, Postoperative, Opioid Use
- Being tested
- lumbar plexus block, suprainguinal fascia iliaca block
- Keywords
- nerve block, fascia iliaca, hip replacement, lumbar plexus
- Medical subject headings
- Osteoarthritis, Hip, Acute Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar plexus blockProcedure or surgery
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 blockProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Lumbar plexus block | Active comparator | Patients randomized to receive an ultrasound-guided lumbar plexus block Receives: Procedure: lumbar plexus block |
| Suprainguinal fascia iliaca block | Experimental | Patients randomized to receive an ultrasound-guided suprainguinal fascia iliaca block Receives: Procedure: suprainguinal fascia iliaca block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption over 24 hours
Total morphine consumption over 24 hours post block
Measured: 24 hours post block
Secondary outcomes (22)
Performance time
Interval between the start of skin disinfection and the end of local anesthetic injection
Measured: 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
Measured: 2 hours after surgery
Postoperative static pain at 3 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Measured: 3 hours after the block
Postoperative static pain at 6 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Measured: 6 hours after the block
Postoperative static pain at 12 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Measured: 12 hours after the block
Postoperative static pain at 24 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Measured: 24 hours after the block
Postoperative dynamic pain at 3 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Measured: 3 hours after the block
Postoperative dynamic pain at 6 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Measured: 6 hours after the block
Postoperative dynamic pain at 12 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Measured: 12 hours after the block
Postoperative dynamic pain at 24 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Measured: 24 hours after the block
Postoperative static pain at 48 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Measured: 48 hours after the block
Postoperative dynamic pain at 48 hours after block
Pain evaluated in Numeric Rating Score from 0 to 10 points
Measured: 48 hours after the block
Time until first morphine demand
Time until first patient-controlled analgesia morphine demand
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 3 hours after block
Incidence of opioid related adverse events
Incidence of adverse events related to opioid use (nausea/vomiting, pruritus, somnolence, respiratory depression)
Measured: 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.
Measured: 24 hours after the block
Surgical duration
Time between skin incision and closure
Measured: 4 hours
Readiness to discharge
Days to be ready for discharge following physiotherapist criteria
Measured: 4 days after surgery
Length of hospital stay
Length of hospital stay after surgery
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start19 Nov 2018
- Primary completion22 Jan 2020
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Bravo Advis, University of Chile
- Investigators
- Daniela Bravo, MD, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744065
- Sponsor's protocol ID
- OAIC1001/18
- Status last verified
- Jun 2020
- First submitted
- 13 Nov 2018
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17961837Klein 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.
PubMed 9416746Aida 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.
PubMed 8602680Aveline 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.
PubMed 15321930Weller 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.
PubMed 12552223Gentili 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.
PubMed 9750813Pousman 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.
PubMed 12717153Duarte 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.
PubMed 19468598Dogan 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.
PubMed 24794455Gadsden 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.
PubMed 18813048Auroy 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 12411815Dalens 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.
PubMed 2589650Dolan 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.
PubMed 19258967Kumar 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.
PubMed 26767235Hebbard 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.
PubMed 21401544
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison Between Ultrasound Guided Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement Analgesia
- ClinicalTrials.gov ID
- NCT03744065
- Acronym / sponsor ID
- OAIC1001/18
- Conditions
- Hip Osteoarthritis, Pain, Acute, Pain, Postoperative, Opioid Use
- Keywords
- nerve block, fascia iliaca, hip replacement, lumbar plexus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 16 Nov 2018 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar plexus block | Active comparator | Procedure: lumbar plexus blockPatients randomized to receive an ultrasound-guided lumbar plexus block |
| Suprainguinal fascia iliaca block | Experimental | Procedure: suprainguinal fascia iliaca blockPatients randomized to receive an ultrasound-guided suprainguinal fascia iliaca block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 80 years
- American Society of Anesthesiologists classification 1-3
- Body mass index between 20 and 35 (kg/m2)
Key exclusion criteria (9 listed)
- 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)
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 |
|---|---|---|
| lumbar plexus blockInjection 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 | Procedure or surgery | Lumbar plexus block |
| suprainguinal fascia iliaca blockInjection 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 | Procedure or surgery | Suprainguinal fascia iliaca block |
Primary outcome
Morphine consumption over 24 hours
Time frame: 24 hours post block
Total morphine consumption over 24 hours post block
22 secondary outcomes
Performance time
Time frame: 2 hours after surgery
Number of needle passes
Time frame: 2 hours after surgery
Postoperative static pain at 3 hours after block
Time frame: 3 hours after the block
Postoperative static pain at 6 hours after block
Time frame: 6 hours after the block
Postoperative static pain at 12 hours after block
Time frame: 12 hours after the block
Postoperative static pain at 24 hours after block
Time frame: 24 hours after the block
Postoperative dynamic pain at 3 hours after block
Time frame: 3 hours after the block
Postoperative dynamic pain at 6 hours after block
Time frame: 6 hours after the block
Postoperative dynamic pain at 12 hours after block
Time frame: 12 hours after the block
Postoperative dynamic pain at 24 hours after block
Time frame: 24 hours after the block
Postoperative static pain at 48 hours after block
Time frame: 48 hours after the block
Postoperative dynamic pain at 48 hours after block
Time frame: 48 hours after the block
Time until first morphine demand
Time frame: 48 hours after the block
Block assessment at 3 hours
Time frame: 3 hours after the block
Block assessment at 6 hours
Time frame: 6 hours after the block
Block assessment at 24 hours
Time frame: 24 hours after the block
Incidence of block related adverse events
Time frame: 3 hours after block
Incidence of opioid related adverse events
Time frame: 48 hours after block
Incidence of Inability to perform physiotherapy
Time frame: 24 hours after the block
Surgical duration
Time frame: 4 hours
Readiness to discharge
Time frame: 4 days after surgery
Length of hospital stay
Time frame: 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Background: PubMed 17961837Siddiqui 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.
- Background: PubMed 9416746Klein 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.
- Background: PubMed 8602680Aida 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.
- Background: PubMed 15321930Aveline 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.
- Background: PubMed 12552223Weller 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.
- Background: PubMed 9750813Gentili 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.
- Background: PubMed 12717153Pousman 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.
- Background: PubMed 19468598Duarte 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.
- Background: PubMed 24794455Dogan 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.
- Background: PubMed 18813048Gadsden 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.
- Background: 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.
- Background: PubMed 2589650Dalens 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.
- 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.
Daniela Bravo, MD principal investigator
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lumbar plexus block and suprainguinal fascia iliaca block in people with Hip Osteoarthritis and Pain, Acute, run by University of Chile at 1 site in Chile.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 4 Jun 2020. 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 Chile. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Morphine consumption over 24 hours (time frame: 24 hours post block). 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 NCT03744065, which also lists 18 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 4 Jun 2020.