OsteoarthritisNCT01931332
Intrathecal Diamorphine Versus Femoral Nerve Block in Primary Total Knee Arthroplasty
A study testing Femoral Nerve Block with levobupivicaine and Intrathecal injection of diamorphine in people with Osteoarthritis, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Primary total knee arthroplasty (TKA) is commonly associated with moderate to severe early post-operative pain. The primary aim of this study was to investigate the impact of either a single-shot femoral nerve block (FNB) or intrathecal diamorphine (ID) on post-operative pain after TKA The Null Hypothesis is that… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Femoral Nerve Block with levobupivicaine and Intrathecal injection of diamorphine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2010to Jul 2012
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients scheduled for primary unilateral Total Knee Arthroplasty
Who cannot join
- Uni-compartmental surgery, bilateral surgery, contra-indication to spinal anaesthesia or peripheral nerve block (anticoagulation, hydrocephalus, raised intracranial pressure), allergy to local anaesthetics or diamorphine, malignant hyperthermia or other concerns over general anaesthesia, chronic opiate use and chronic pain medication use (e.g. gabapentin, pregabalin, amitriptyline).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Devon and Exeter Hospital
Exeter, Devon, EX1 2ED
About this study
Official title: Randomised, Observer Blinded, Controlled Trial of Intrathecal Diamorphine Versus Femoral Nerve Block for Post-operative Analgesia Following Primary Total Knee Arthroplasty
Primary total knee arthroplasty (TKA) is commonly associated with moderate to severe early post-operative pain. The primary aim of this study was to investigate the impact of either a single-shot femoral nerve block (FNB) or intrathecal diamorphine (ID) on post-operative pain after TKA
The Null Hypothesis is that there is no difference in the post operative pain relief provided for TKA by a single-shot femoral nerve block (FNB) as compared to intrathecal diamorphine (ID).
Read the detailed description
In 2008, the Prospect Working Group, a multidisciplinary expert panel, published their consensus guidelines on the relative merits of different anaesthetic and analgesic techniques for TKA based on a review of the available published literature up to 2005. These guidelines supported the use of general anaesthesia combined with a femoral nerve block for surgery and postoperative analgesia, or alternatively spinal anaesthesia with local anaesthetic combined with spinal morphine. The preference for femoral nerve block in favour of intrathecal opiates was as a consequence of the greater potential for side effects with the latter technique. The authors conceded that there were a lack of well-conducted studies on this subject, graded their recommendations as level D (expert opinion), and concluded further research was needed. Consequently there has been debate around the conclusions drawn and clinicians have not universally accepted the recommendations.
Most researchers to date have focused on short-term outcomes such as static pain scores and/or opiate consumption. It is also important however to investigate dynamic pain scores, patient reported outcomes, the attainment of rehabilitation goals, length of stay and longer term functional outcomes. In addition, the use of the total pain relief score (TOTPAR) as described by Cooper and Beaver, assesses the cumulative response to treatment. This is a well validated area under the time-analgesic effect curve (AUC) derivation for pain relief which is commonly used by meta-analyses of analgesic interventions. The aim of this study is to investigate all these endpoints in patients receiving a single-shot femoral nerve block (FNB) for TKA as compared to intrathecal diamorphine (ID), a more commonly used spinal opiate in United Kingdom anaesthetic practice.
- Conditions
- Osteoarthritis
- Being tested
- Femoral Nerve Block with levobupivicaine, Intrathecal injection of diamorphine
- Keywords
- Arthroplasty, Analgesia
- Medical subject headings
- Osteoarthritis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral Nerve Block with levobupivicaineProcedure or surgery
A single injection femoral nerve block (FNB) performed in the supine position with a 50mm insulated needle (NanoLine, Pajunk, Geisingen, Germany) and peripheral nerve stimulator set at 1Hz with pulse width 0.1ms. Once a quadriceps muscle twitch is identified at a stimulated current between 0.2 and 0.5mA, 20mls of 0.375% levobupivacaine (75mg) is injected in fractionated amounts after negative aspiration
Intrathecal injection of diamorphineProcedure or surgery
500mcg of intrathecal diamorphine (ID) (dissolved in 0.5mls normal saline)
| Study group | Role | What they receive |
|---|---|---|
| Femoral Nerve Block with levobupivicaine | Active comparator | A single injection femoral nerve block (FNB) was performed in the supine position with a 50mm insulated needle (NanoLine, Pajunk, Geisingen, Germany) and peripheral nerve stimulator set at 1Hertz (Hz) with pulse width 0.1ms. Once a quadriceps muscle twitch was identified at a stimulated current between 0.2 and 0.5milliamperes (mA), 20mls of 0.375% levobupivacaine (75mg) was injected in fractionated amounts after negative aspiration Receives: Procedure: Femoral Nerve Block with levobupivicaine |
| Intrathecal injection of diamorphine | Active comparator | 500mcg of intrathecal diamorphine (ID) (dissolved in 0.5mls normal saline) Receives: Procedure: Intrathecal injection of diamorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median pain score (NRS: see below) at rest
Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain) assessed at times 3, 6, 12, 24, 48 and 72 hrs postoperatively.
Measured: Over 72 hours post operatively
Secondary outcomes (13)
Pain on movement
Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)
Measured: At 3 hrs postoperatively
Pain on movement
Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)
Measured: At 6 hrs postoperatively
Pain on movement
Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)
Measured: At 12 hrs postoperatively
Pain on movement
Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)
Measured: At 24 hrs postoperatively
Pain on movement
Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)
Measured: At 48 hrs postoperatively
Pain on movement
Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)
Measured: At 72 hrs postoperatively
Pain at rest
Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)
Measured: At 3 hrs postoperatively
Pain at rest
Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)
Measured: At 6 hrs postoperatively
Pain at rest
Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)
Measured: At 12 hrs postoperatively
Pain at rest
Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)
Measured: At 24 hrs postoperatively
Pain at rest
Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)
Measured: At 48 hrs postoperatively
Pain at rest
Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)
Measured: At 72 hrs postoperatively
Morphine consumption
Cumulative consumption in milligrams
Measured: Over 72 hrs postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startFeb 2010
- Primary completionMay 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Grayling, Royal Devon and Exeter NHS Foundation Trust
- Investigators
- Matthew Grayling, MBBS, Principal investigator, Royal Devon and Exeter Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931332
- Sponsor's protocol ID
- 10/H0202/1
- Status last verified
- Aug 2013
- First submitted
- 20 Aug 2013
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Observer Blinded, Controlled Trial of Intrathecal Diamorphine Versus Femoral Nerve Block for Post-operative Analgesia Following Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01931332
- Acronym / sponsor ID
- 10/H0202/1
- Conditions
- Osteoarthritis
- Keywords
- Arthroplasty, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 29 Aug 2013 (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.
Primary total knee arthroplasty (TKA) is commonly associated with moderate to severe early post-operative pain. The primary aim of this study was to investigate the impact of either a single-shot femoral nerve block (FNB) or intrathecal diamorphine (ID) on post-operative pain after TKA
The Null Hypothesis is that there is no difference in the post operative pain relief provided for TKA by a single-shot femoral nerve block (FNB) as compared to intrathecal diamorphine (ID).
Detailed description
In 2008, the Prospect Working Group, a multidisciplinary expert panel, published their consensus guidelines on the relative merits of different anaesthetic and analgesic techniques for TKA based on a review of the available published literature up to 2005. These guidelines supported the use of general anaesthesia combined with a femoral nerve block for surgery and postoperative analgesia, or alternatively spinal anaesthesia with local anaesthetic combined with spinal morphine. The preference for femoral nerve block in favour of intrathecal opiates was as a consequence of the greater potential for side effects with the latter technique. The authors conceded that there were a lack of well-conducted studies on this subject, graded their recommendations as level D (expert opinion), and concluded further research was needed. Consequently there has been debate around the conclusions drawn and clinicians have not universally accepted the recommendations.
Most researchers to date have focused on short-term outcomes such as static pain scores and/or opiate consumption. It is also important however to investigate dynamic pain scores, patient reported outcomes, the attainment of rehabilitation goals, length of stay and longer term functional outcomes. In addition, the use of the total pain relief score (TOTPAR) as described by Cooper and Beaver, assesses the cumulative response to treatment. This is a well validated area under the time-analgesic effect curve (AUC) derivation for pain relief which is commonly used by meta-analyses of analgesic interventions. The aim of this study is to investigate all these endpoints in patients receiving a single-shot femoral nerve block (FNB) for TKA as compared to intrathecal diamorphine (ID), a more commonly used spinal opiate in United Kingdom anaesthetic practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral Nerve Block with levobupivicaine | Active comparator | Procedure: Femoral Nerve Block with levobupivicaineA single injection femoral nerve block (FNB) was performed in the supine position with a 50mm insulated needle (NanoLine, Pajunk, Geisingen, Germany) and peripheral nerve stimulator set at 1Hertz (Hz) with pulse width 0.1ms. Once a quadriceps muscle twitch was identified at a stimulated current between 0.2 and 0.5milliamperes (mA), 20mls of 0.375% levobupivacaine (75mg) was injected in fractionated amounts after negative aspiration |
| Intrathecal injection of diamorphine | Active comparator | Procedure: Intrathecal injection of diamorphine500mcg of intrathecal diamorphine (ID) (dissolved in 0.5mls normal saline) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients scheduled for primary unilateral Total Knee Arthroplasty
Key exclusion criteria (1 listed)
- Uni-compartmental surgery, bilateral surgery, contra-indication to spinal anaesthesia or peripheral nerve block (anticoagulation, hydrocephalus, raised intracranial pressure), allergy to local anaesthetics or diamorphine, malignant hyperthermia or other concerns over general anaesthesia, chronic opiate use and chronic pain medication use (e.g. gabapentin, pregabalin, amitriptyline).
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 |
|---|---|---|
| Femoral Nerve Block with levobupivicaineA single injection femoral nerve block (FNB) performed in the supine position with a 50mm insulated needle (NanoLine, Pajunk, Geisingen, Germany) and peripheral nerve stimulator set at 1Hz with pulse width 0.1ms. Once a quadriceps muscle twitch is identified at a stimulated current between 0.2 and 0.5mA, 20mls of 0.375% levobupivacaine (75mg) is injected in fractionated amounts after negative aspiration | Procedure or surgery | Femoral Nerve Block with levobupivicaine |
| Intrathecal injection of diamorphine500mcg of intrathecal diamorphine (ID) (dissolved in 0.5mls normal saline) | Procedure or surgery | Intrathecal injection of diamorphine |
Primary outcome
Median pain score (NRS: see below) at rest
Time frame: Over 72 hours post operatively
Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain) assessed at times 3, 6, 12, 24, 48 and 72 hrs postoperatively.
13 secondary outcomes
Pain on movement
Time frame: At 3 hrs postoperatively
Pain on movement
Time frame: At 6 hrs postoperatively
Pain on movement
Time frame: At 12 hrs postoperatively
Pain on movement
Time frame: At 24 hrs postoperatively
Pain on movement
Time frame: At 48 hrs postoperatively
Pain on movement
Time frame: At 72 hrs postoperatively
Pain at rest
Time frame: At 3 hrs postoperatively
Pain at rest
Time frame: At 6 hrs postoperatively
Pain at rest
Time frame: At 12 hrs postoperatively
Pain at rest
Time frame: At 24 hrs postoperatively
Pain at rest
Time frame: At 48 hrs postoperatively
Pain at rest
Time frame: At 72 hrs postoperatively
Morphine consumption
Time frame: Over 72 hrs postoperatively
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 29 Aug 2013.
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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.
Matthew Grayling, MBBS principal investigator
Royal Devon and Exeter Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral Nerve Block with levobupivicaine and Intrathecal injection of diamorphine in people with Osteoarthritis, run by Royal Devon and Exeter NHS Foundation Trust 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 1 inclusion and 1 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 29 Aug 2013. 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. 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?
Median pain score (NRS: see below) at rest (time frame: Over 72 hours post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2013.