AnalgesiaNCT01217294
Study Comparing a Nerve Block With Spinal Opiate to Provide Pain Relief for Hip Replacement Surgery
A study testing ultrasound guided fascia iliaca block and spinal morphine in people with Analgesia, run by Rachel Kearns at 1 site in United Kingdom.
Trial summary
Pain control after hip replacement surgery is important to ensure patient comfort, allow mobilisation, and aid recovery. The investigators propose a simple and pragmatic study comparing two different anaesthetic techniques in the provision of pain relief after hip surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Analgesia
- What is being tested?
- ultrasound guided fascia iliaca block and spinal morphine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2011to Apr 2014
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- Competent to give consent
- ASA physical status I - III
- 18-85 years of age, inclusive
- 50-110 kg, inclusive
- Scheduled for unilateral primary hip arthroplasty
Who cannot join
- Contraindications to fascia iliaca plane block
- Contraindication to spinal anaesthesia
- Coagulopathy, malignancy or infection in the inguinal area
- Patient preference for general anaesthesia
- Allergy to opioids
- Significant peripheral neuropathy or neurologic disorder affecting the lower extremity
Show all 10Show fewer
- Pregnancy
- History of alcohol or drug dependency / abuse
- History of long term opioid intake
- History of significant psychiatric conditions that may affect patient assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrathecal Opioid Versus Ultrasound Guided Fascia Iliaca Plane Block for Analgesia After Primary Hip Arthroplasty
Pain control after hip replacement surgery is important to ensure patient comfort, allow mobilisation, and aid recovery. The investigators propose a simple and pragmatic study comparing two different anaesthetic techniques in the provision of pain relief after hip surgery. Patients will be randomised to receive either spinal anaesthesia containing morphine or spinal anaesthesia without morphine and an ultrasound guided fascia iliaca nerve block. Although morphine is an effective pain killer, its side effects include itch, urinary retention, nausea and potentially fatal breathing problems. If the nerve block can be shown to provide comparable pain relief to spinal morphine, then morphine could be removed from the spinal injection. This could reduce side effects and improve patient safety. The investigators wish to investigate whether ultrasound guided fascia iliaca plane block provides analgesia which is comparable to that of intrathecal opioid for primary hip arthroplasty in the first 24 hours after hip replacement surgery
Read the detailed description
There were 6312 primary hip replacements performed in Scotland during the one year period 2007 - 2008. Patients undergoing hip arthroplasty commonly have significant comorbidity and associated polypharmacy providing many potential challenges for the anaesthetic doctor. The optimal way to anaesthetise these patients remains to be fully established although many potential methods exist. The main choice is between general anaesthesia (GA) and regional anaesthesia (RA) or a combination of the two. In a recent systematic review, RA was found to reduce post-operative pain, morphine consumption and nausea and vomiting compared with systemic analgesia.
Spinal anaesthesia is a popular form of RA used in many patients undergoing hip arthroplasty. Opioid drugs are frequently added to the spinal injection in order to prolong post-operative pain relief. However, this is associated with side effects including respiratory depression, urinary retention, nausea and vomiting, and pruritus. Such adverse effects may be uncomfortable for the patient and can delay mobilisation, recovery and eventual discharge.
In patients undergoing hip arthroplasty, peripheral nerve blockade has been shown to improve pain scores and reduce morphine consumption. A peripheral nerve block called the fascia iliaca plane block has shown significant promise as a method of providing sensory blockade of the main nerves which supply pain to the hip. The use of ultrasound for the performance of fascia iliaca plane block has been shown to increase reliability compared with the landmark technique though the clinical benefits of this have not yet been fully investigated.
Compared to nerve stimulation or landmark techniques of nerve localisation, ultrasound has been shown to increase success rates, reduce block onset time, increase block duration, reduce volumes of local anaesthetic required and increase patient satisfaction.
The investigators hypothesise that by increasing the success rate of the fascia iliaca block with ultrasound, it will be possible to achieve superior analgesia post-operatively. Our aim is to assess whether the ultrasound guided fascia iliaca plane block can be used as an alternative to intrathecal morphine in the provision of post-operative analgesia for primary hip arthroplasty. If this is the case, intrathecal opioid could be removed from the spinal anaesthetic. This could in theory have significant safety benefits whilst also reducing side effects. Ultrasound guided fascia iliaca block has not yet been evaluated clinically as a method of providing post-operative analgesia following primary hip arthroplasty. The investigators believe that further investigation of this technique will provide a valuable contribution to existing knowledge and will change current practice.
- Conditions
- Analgesia
- Being tested
- ultrasound guided fascia iliaca block, spinal morphine
- Keywords
- anaesthetic techniques, regional, analgesia, post-operative, fascia iliaca compartment block, ultrasound guided, surgery, orthopaedic
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided fascia iliaca blockProcedure or surgery
Spinal anaesthesia with hyperbaric bupivacaine at a dose between 10 and 15mg as deemed appropriate by the anaesthetic doctor performing the spinal injection, no spinal morphine and ultrasound guided fascia iliaca plane block using 2mg/kg levobupivacaine diluted to a total of 40ml with sterile saline.
spinal morphineProcedure or surgery
Spinal anaesthesia with hyperbaric bupivacaine 10 - 15mg as deemed appropriate by the anaesthetists performing the spinal injection, and with the addition of intrathecal morphine 100 micrograms. Sham fascia iliaca plane injection with saline.
| Study group | Role | What they receive |
|---|---|---|
| spinal morphine, sham block | Sham comparator | Spinal anaesthesia with hyperbaric bupivacaine 10 - 15mg as specified by the anaesthetist performing the spinal injection, and with the addition of intrathecal morphine 100 micrograms. Sham ultrasound guided fascia iliaca plane block with saline.
Post-operative analgesia with Paracetamol 1g four times daily, and patient controlled analgesia (PCA) with morphine (1mg bolus, 5 minute lockout period) Receives: Procedure: spinal morphine |
| ultrasound guided fascia iliaca block | Active comparator | Spinal anaesthesia with hyperbaric bupivacaine at a dose between 10 and 15mg as deemed appropriate by the anaesthetic doctor performing the spinal injection, no spinal morphine and fascia iliaca plane block using 2mg/kg levobupivacaine diluted to a total of 40ml with sterile saline.
Post-operative analgesia with Paracetamol 1g four times daily, and patient controlled analgesia (PCA) with morphine (1mg bolus, 5 minute lockout period) Receives: Procedure: ultrasound guided fascia iliaca block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome will be post-operative morphine consumption in a 24 hour period as self-administered using a patient controlled analgesia (PCA) pump.
We hypothesise that ultrasound guided fasca iliaca plane block provides analgesia which is comparable to that of intrathecal opioid for primary hip arthroplasty in the first 24 hours after surgery. This study is powered to detect a difference of 10mg of morphine within a 24 hour period. We would consider a dose of 10mg as being significant clinically.
Measured: 24 hours
Secondary outcomes (8)
Pain scores
Pain scores at 48 hours as recorded post-operatively on the PCA chart where time zero is the end of the operation (numerical pain rating score 0 - 10 where 0 is no pain and 10 is worst pain imaginable).
Measured: 48 hours
Hypotension
Incidence of hypotension as defined by systolic blood pressure < 80mmHg or a drop of >25% from baseline systolic pressure, or requiring vasopressor in the first 48 hours post-operatively.
Measured: 48 hours
post-operative nausea and vomiting
Incidence of post-operative nausea and vomiting as defined by nausea score of greater than or equal to 2 (on a PONV scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe nausea and 4 = patient vomiting) or requiring the administration of an anti-emetic agent in the first 48 hours post-operatively.
Measured: 48 hours
Pruritus
Incidence of pruritus as defined by itch felt to be distressing by the patient on questioning after the first 48 hour period post-operatively or requiring treatment with naloxone.
Measured: 48 hours
Sedation
Incidence of sedation as defined by sedation score of greater than or equal to 2 (where 0 = awake, S = normal sleep, 1 = drowsy but easy to rouse, 2 = sedated and difficult to rouse, and 3 = unconscious) or requiring naloxone administration in the first 48 hours post-operatively.
Measured: 48 hours
Urinary retention
Incidence of urinary retention as defined by the requirement for urinary catheterisation due to failure to pass urine in the first 48 hours post-operatively.
Measured: 48 hours
First mobilisation
Time to first mobilisation as defined by patient able to mobilise from bed to chair in hours from time zero as recorded by physiotherapy staff.
Measured: 48 hours
Patient satisfaction
Patient satisfaction as measured using a visual analogue scale (VAS) from 0 - 100mm where 0 is absolutely not satisfied and 100 is completely satisfied. This will be performed after 48 hours and at a routine follow up appointment 3 months after discharge.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startMay 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rachel Kearns
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Responsible party
- Sponsor-investigator, Rachel Kearns, University of Glasgow
- Investigators
- John Kinsella, MBBS MD, Principal investigator, University Section of Anaesthesia, Glasgow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217294
- Sponsor's protocol ID
- GN10AN280
- Status last verified
- Apr 2014
- First submitted
- 6 Oct 2010
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kearns RJ, Macfarlane AJ, Anderson KJ, Kinsella J. Intrathecal opioid versus ultrasound guided fascia iliaca plane block for analgesia after primary hip arthroplasty: study protocol for a randomised, blinded, noninferiority controlled trial. Trials. 2011 Feb 21;12:51. doi: 10.1186/1745-6215-12-51.
PubMed 21338492
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Opioid Versus Ultrasound Guided Fascia Iliaca Plane Block for Analgesia After Primary Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01217294
- Acronym / sponsor ID
- GN10AN280
- Conditions
- Analgesia
- Keywords
- anaesthetic techniques, regional, analgesia, post-operative, fascia iliaca compartment block, ultrasound guided, surgery, orthopaedic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Rachel KearnsUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Study start
- May 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 8 Oct 2010 (estimated)
- 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.
Pain control after hip replacement surgery is important to ensure patient comfort, allow mobilisation, and aid recovery. The investigators propose a simple and pragmatic study comparing two different anaesthetic techniques in the provision of pain relief after hip surgery. Patients will be randomised to receive either spinal anaesthesia containing morphine or spinal anaesthesia without morphine and an ultrasound guided fascia iliaca nerve block. Although morphine is an effective pain killer, its side effects include itch, urinary retention, nausea and potentially fatal breathing problems. If the nerve block can be shown to provide comparable pain relief to spinal morphine, then morphine could be removed from the spinal injection. This could reduce side effects and improve patient safety. The investigators wish to investigate whether ultrasound guided fascia iliaca plane block provides analgesia which is comparable to that of intrathecal opioid for primary hip arthroplasty in the first 24 hours after hip replacement surgery
Detailed description
There were 6312 primary hip replacements performed in Scotland during the one year period 2007 - 2008. Patients undergoing hip arthroplasty commonly have significant comorbidity and associated polypharmacy providing many potential challenges for the anaesthetic doctor. The optimal way to anaesthetise these patients remains to be fully established although many potential methods exist. The main choice is between general anaesthesia (GA) and regional anaesthesia (RA) or a combination of the two. In a recent systematic review, RA was found to reduce post-operative pain, morphine consumption and nausea and vomiting compared with systemic analgesia.
Spinal anaesthesia is a popular form of RA used in many patients undergoing hip arthroplasty. Opioid drugs are frequently added to the spinal injection in order to prolong post-operative pain relief. However, this is associated with side effects including respiratory depression, urinary retention, nausea and vomiting, and pruritus. Such adverse effects may be uncomfortable for the patient and can delay mobilisation, recovery and eventual discharge.
In patients undergoing hip arthroplasty, peripheral nerve blockade has been shown to improve pain scores and reduce morphine consumption. A peripheral nerve block called the fascia iliaca plane block has shown significant promise as a method of providing sensory blockade of the main nerves which supply pain to the hip. The use of ultrasound for the performance of fascia iliaca plane block has been shown to increase reliability compared with the landmark technique though the clinical benefits of this have not yet been fully investigated.
Compared to nerve stimulation or landmark techniques of nerve localisation, ultrasound has been shown to increase success rates, reduce block onset time, increase block duration, reduce volumes of local anaesthetic required and increase patient satisfaction.
The investigators hypothesise that by increasing the success rate of the fascia iliaca block with ultrasound, it will be possible to achieve superior analgesia post-operatively. Our aim is to assess whether the ultrasound guided fascia iliaca plane block can be used as an alternative to intrathecal morphine in the provision of post-operative analgesia for primary hip arthroplasty. If this is the case, intrathecal opioid could be removed from the spinal anaesthetic. This could in theory have significant safety benefits whilst also reducing side effects. Ultrasound guided fascia iliaca block has not yet been evaluated clinically as a method of providing post-operative analgesia following primary hip arthroplasty. The investigators believe that further investigation of this technique will provide a valuable contribution to existing knowledge and will change current practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal morphine, sham block | Sham comparator | Procedure: spinal morphineSpinal anaesthesia with hyperbaric bupivacaine 10 - 15mg as specified by the anaesthetist performing the spinal injection, and with the addition of intrathecal morphine 100 micrograms. Sham ultrasound guided fascia iliaca plane block with saline. Post-operative analgesia with Paracetamol 1g four times daily, and patient controlled analgesia (PCA) with morphine (1mg bolus, 5 minute lockout period) |
| ultrasound guided fascia iliaca block | Active comparator | Procedure: ultrasound guided fascia iliaca blockSpinal anaesthesia with hyperbaric bupivacaine at a dose between 10 and 15mg as deemed appropriate by the anaesthetic doctor performing the spinal injection, no spinal morphine and fascia iliaca plane block using 2mg/kg levobupivacaine diluted to a total of 40ml with sterile saline. Post-operative analgesia with Paracetamol 1g four times daily, and patient controlled analgesia (PCA) with morphine (1mg bolus, 5 minute lockout period) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- English-speaking
- Competent to give consent
- ASA physical status I - III
- 18-85 years of age, inclusive
- 50-110 kg, inclusive
Key exclusion criteria (10 listed)
- Contraindications to fascia iliaca plane block
- Contraindication to spinal anaesthesia
- Coagulopathy, malignancy or infection in the inguinal area
- Patient preference for general anaesthesia
- Allergy to opioids
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 |
|---|---|---|
| ultrasound guided fascia iliaca blockSpinal anaesthesia with hyperbaric bupivacaine at a dose between 10 and 15mg as deemed appropriate by the anaesthetic doctor performing the spinal injection, no spinal morphine and ultrasound guided fascia iliaca plane block using 2mg/kg levobupivacaine diluted to a total of 40ml with sterile saline. | Procedure or surgery | ultrasound guided fascia iliaca block |
| spinal morphineSpinal anaesthesia with hyperbaric bupivacaine 10 - 15mg as deemed appropriate by the anaesthetists performing the spinal injection, and with the addition of intrathecal morphine 100 micrograms. Sham fascia iliaca plane injection with saline. | Procedure or surgery | spinal morphine, sham block |
Primary outcome
Primary outcome will be post-operative morphine consumption in a 24 hour period as self-administered using a patient controlled analgesia (PCA) pump.
Time frame: 24 hours
We hypothesise that ultrasound guided fasca iliaca plane block provides analgesia which is comparable to that of intrathecal opioid for primary hip arthroplasty in the first 24 hours after surgery. This study is powered to detect a difference of 10mg of morphine within a 24 hour period. We would consider a dose of 10mg as being significant clinically.
8 secondary outcomes
Pain scores
Time frame: 48 hours
Hypotension
Time frame: 48 hours
post-operative nausea and vomiting
Time frame: 48 hours
Pruritus
Time frame: 48 hours
Sedation
Time frame: 48 hours
Urinary retention
Time frame: 48 hours
First mobilisation
Time frame: 48 hours
Patient satisfaction
Time frame: 48 hours
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 10 Apr 2014.
- Derived from this study: PubMed 21338492Kearns RJ, Macfarlane AJ, Anderson KJ, Kinsella J. Intrathecal opioid versus ultrasound guided fascia iliaca plane block for analgesia after primary hip arthroplasty: study protocol for a randomised, blinded, noninferiority controlled trial. Trials. 2011 Feb 21;12:51. doi: 10.1186/1745-6215-12-51.
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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.
John Kinsella, MBBS MD principal investigator
University Section of Anaesthesia, Glasgow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided fascia iliaca block and spinal morphine in people with Analgesia, run by Rachel Kearns at 1 site in United Kingdom.
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 6 inclusion and 10 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 10 Apr 2014. 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 United Kingdom. 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.
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?
Primary outcome will be post-operative morphine consumption in a 24 hour period as self-administered using a patient controlled analgesia (PCA) pump. (time frame: 24 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 NCT01217294, which also lists 1 linked publication.
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 10 Apr 2014.