PainPCANCT01187537
Effects of Continuous Nerve Block vs Single Injection Block With PCA vs PCA on Pain and Function After Knee Replacement
A study testing Continuous Femoral Nerve Block in people with Pain, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
The purpose of this study is to compare the effectiveness of three analgesia techniques on pain relief and functional recovery after knee replacement: continuous femoral nerve block vs single-injection femoral nerve block with intravenous patient controlled analgesia vs intravenous patient controlled analgesia. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Pain
- What is being tested?
- Continuous Femoral Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2009to Dec 2011
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years and above
- Osteoarthritis
- Primary unilateral total knee replacement
- No other lower extremity joint disease
- ASA I-III
- Body mass index < 35
Show all 10Show fewer
- No severe cardiac or pulmonary diseases
- No chronic narcotic therapy or illicit drug use
- Mentally competent to understand study procedures and use of pain scales
- Able to provide informed consent
Who cannot join
- Any cause for knee replacement other than osteoarthritis
- Total knee revision
- Any contraindication for femoral block
- Abnormal coagulation studies
- Thrombocytopenia less than 100,000/cc
- Known hepatic or renal insufficiency
Show all 14Show fewer
- Neurological disease involving lower extremities
- Major surgery during the last 2 weeks pre-operatively
- History of allergy to study medications
- History of post-operative bleeding over 2000 cc/24 hours
- History of opioid or alcohol abuse
- Currently taking or has taken opioid > 30 consecutive days of daily use at a daily dose > 15mg morphine, within the past 2 weeks prior to surgery
- Previously has not responded to opioid analgesics for treatment of pain
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Continuous Femoral Nerve Block Versus Single-Injection Femoral Nerve Block With Intravenous Patient Controlled Analgesia Versus Intravenous Patient Controlled Analgesia on Knee Pain and Function After Total Knee Replacement
The purpose of this study is to compare the effectiveness of three analgesia techniques on pain relief and functional recovery after knee replacement: continuous femoral nerve block vs single-injection femoral nerve block with intravenous patient controlled analgesia vs intravenous patient controlled analgesia.
Read the detailed description
Primary Outcome Measures:
- Incidence of patients with significant pain on movement on day 1 post surgery
- Range of knee flexion
Secondary Outcome Measures:
- Pain intensity (rest/movement)
- Functional recovery
- Knee Injury and Osteoarthritis Score
- Side effects/ Adverse outcomes
- SF12 Quality of Life Questionnaire
- Length of stay
- Conditions
- Pain
- Being tested
- Continuous Femoral Nerve Block
- Keywords
- Knee Replacement, Analgesia, Analgesics, Nerve blocks, Recovery of functions, Post operative analgesia
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Femoral Nerve BlockProcedure or surgery
Also called Bupivacaine
20mls of 0.25% Bupivacaine with 1/400,000 adrenaline (2.5mcg/ml) If catheter localized to < 1.0mA, 0.1mS with patella twitch, start Bupivacaine 0.125% 4ml/hr. If unable to get twitch through catheter in final location or twitch at current ≥ 1.0m/A, start Bupivacaine 0.125% 6ml/hr.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Femoral Nerve Block | Experimental | Not described Receives: Procedure: Continuous Femoral Nerve Block |
| Single-Inj Nerve Block with IV PCA | Active comparator | Not described Receives: Procedure: Continuous Femoral Nerve Block |
| IV PCA | Active comparator | Not described Receives: Procedure: Continuous Femoral Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of patients with significant pain on movement on day 1 post surgery
Measured: Post op day 1
Secondary outcomes (1)
Functional recovery
Measured: During hospitalization, week 2, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startJul 2009
- Primary completionJun 2011
- Study completionDec 2011
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 PainStudies 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
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chan Ee Yuee, Tan Tock Seng Hospital
- Investigators
- Ee Yuee Chan, Principal investigator, Tan Tock Seng HospitalNelson Chua, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187537
- Sponsor's protocol ID
- SIG/09052
- Acronym
- PCA
- Status last verified
- Aug 2010
- First submitted
- 22 Aug 2010
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chan EY, Teo YH, Assam PN, Fransen M. Functional discharge readiness and mobility following total knee arthroplasty for osteoarthritis: a comparison of analgesic techniques. Arthritis Care Res (Hoboken). 2014 Nov;66(11):1688-94. doi: 10.1002/acr.22361.
PubMed 24782108
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continuous Femoral Nerve Block Versus Single-Injection Femoral Nerve Block With Intravenous Patient Controlled Analgesia Versus Intravenous Patient Controlled Analgesia on Knee Pain and Function After Total Knee Replacement
- ClinicalTrials.gov ID
- NCT01187537
- Acronym / sponsor ID
- PCA / SIG/09052
- Conditions
- Pain
- Keywords
- Knee Replacement, Analgesia, Analgesics, Nerve blocks, Recovery of functions, Post operative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Aug 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.
The purpose of this study is to compare the effectiveness of three analgesia techniques on pain relief and functional recovery after knee replacement: continuous femoral nerve block vs single-injection femoral nerve block with intravenous patient controlled analgesia vs intravenous patient controlled analgesia.
Detailed description
Primary Outcome Measures:
- Incidence of patients with significant pain on movement on day 1 post surgery
- Range of knee flexion
Secondary Outcome Measures:
- Pain intensity (rest/movement)
- Functional recovery
- Knee Injury and Osteoarthritis Score
- Side effects/ Adverse outcomes
- SF12 Quality of Life Questionnaire
- Length of stay
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous Femoral Nerve Block | Experimental | Procedure: Continuous Femoral Nerve Block |
| Single-Inj Nerve Block with IV PCA | Active comparator | Procedure: Continuous Femoral Nerve Block |
| IV PCA | Active comparator | Procedure: Continuous Femoral Nerve Block |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 40 years and above
- Osteoarthritis
- Primary unilateral total knee replacement
- No other lower extremity joint disease
- ASA I-III
Key exclusion criteria (14 listed)
- Any cause for knee replacement other than osteoarthritis
- Total knee revision
- Any contraindication for femoral block
- Abnormal coagulation studies
- Thrombocytopenia less than 100,000/cc
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 |
|---|---|---|
| Continuous Femoral Nerve BlockAlso: Bupivacaine20mls of 0.25% Bupivacaine with 1/400,000 adrenaline (2.5mcg/ml) If catheter localized to < 1.0mA, 0.1mS with patella twitch, start Bupivacaine 0.125% 4ml/hr. If unable to get twitch through catheter in final location or twitch at current ≥ 1.0m/A, start Bupivacaine 0.125% 6ml/hr. | Procedure or surgery | Continuous Femoral Nerve Block, IV PCA, Single-Inj Nerve Block with IV PCA |
Primary outcome
Incidence of patients with significant pain on movement on day 1 post surgery
Time frame: Post op day 1
1 secondary outcome
Functional recovery
Time frame: During hospitalization, week 2, week 12
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 13 May 2016.
- Derived from this study: PubMed 24782108Chan EY, Teo YH, Assam PN, Fransen M. Functional discharge readiness and mobility following total knee arthroplasty for osteoarthritis: a comparison of analgesic techniques. Arthritis Care Res (Hoboken). 2014 Nov;66(11):1688-94. doi: 10.1002/acr.22361.
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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.
Ee Yuee Chan principal investigator
Tan Tock Seng Hospital
Nelson Chua principal investigator
Tan Tock Seng 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 Continuous Femoral Nerve Block in people with Pain, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 10 inclusion and 14 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 13 May 2016. 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 Singapore. 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?
Incidence of patients with significant pain on movement on day 1 post surgery (time frame: Post op day 1). 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 NCT01187537, 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 13 May 2016.