Post Operative PainPhase 4NCT01991288
Analgesic Efficacy of Saphenous Nerve Block in Total Knee Replacement
A Phase 4 study testing SNB Saphenous Nerve Block and NSNB Non Saphenous Nerve Block in people with Post Operative Pain, run by Cork University Hospital at 1 site in Ireland.
Trial summary
We hypothesize that preoperative saphenous nerve block (SNB) in combination with periarticular local infiltration provides better post operative pain relief (POPR) profile as compared to local infiltration alone Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- SNB Saphenous Nerve Block and NSNB Non Saphenous Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- Nov 2012to Jul 2013
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anaesthesia (ASA) Grade I-lll patients Undergoing elective Total Knee Arthroplasty Patients able to consent and understand all the components of the study.
Who cannot join
- Demented patients Patients having bilateral Knee Replacements Patients unable to comprehend the use of pain scales Allergy to any of the medications used in the study Renal dysfunction Coagulation disorders Peptic ulcer disease precluding use of non-steroidal anti-inflammatory drugs (NSAIDs) Patients unable to use regular opioid medication Any chronic pain condition other than osteoarthritis of the knee.
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Dept. of Anaesthesia & Intensive Care Unit, Cork University Hospital
Cork, Cork, 0000
About this study
Official title: Does Saphenous Nerve Block Improve Analgesia After Total Knee Replacement When Used in Combination With Local Infiltration Analgesia? A Prospective Randomised Double Blinded Trial.
We hypothesize that preoperative saphenous nerve block (SNB) in combination with periarticular local infiltration provides better post operative pain relief (POPR) profile as compared to local infiltration alone
Read the detailed description
Introduction:
Local infiltration analgesia (LIA) is considered acceptable after total knee replacements (TKR) in terms of analgesia, ease of performance, early mobilization and early hospital discharge . Continuous femoral nerve block has been used to enhance post op pain relief (POPR) for TKR but at the expense of motor blockade . A Sub sartorial approach to saphenous nerve block (SNB) spares the motor block . To date the role of saphenous nerve block for POPR in TKR has not been evaluated.
Methodology:
In order to test this hypothesis, we proposed to carry out a prospective randomized controlled double blinded (surgeon and assessor) trial study. With institutional ethics approval and having obtained written informed consent from each patient, 20 ASA 1 - 3 patients scheduled to undergo TKR under spinal anesthesia +/- sedation were allocated to one of two groups i.e. Group (SNB): patients receiving SNB sub sartorial approach and Group (NSNB): patients not receiving SNB.
Group allocation was determined using computer generated random number tables. Sealed envelopes were opened on the day of the surgery by the attending anesthetist responsible for the care of the recruited patient.
Postoperative period:
Patients were then assessed for pain at rest and on movement on arrival in recovery and then at 6 , 12 and 24 hrs. Visual analogue scale on a 10 cm straight line was used to assess postoperative pain scores as predictive value of post operative analgesia on rest and movement i.e passive flexion of knee to 30 degree . Patients were assessed for any motor block by using maximum tolerable range of active knee flexion (MKF) and maximum range of straight leg raise(MSLR) on arrival in recovery and at 6, 12 and 24 hrs. All patients received regular paracetamol 1g 6 hourly, diclofenac 75 mg 12 hourly, oxycontin 10-20 mg ( depending on age) 12 hourly and oxynorm 10 mg as rescue analgesia.
- Conditions
- Post Operative Pain
- Being tested
- SNB Saphenous Nerve Block, NSNB Non Saphenous Nerve Block
- Keywords
- Total Knee Replacement, Bupivacaine, Levobupivacaine, Saphenous Nerve Block, Local Infiltration Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNB Saphenous Nerve BlockProcedure or surgery
Also called Bupivacaine, Levobupivacaine, Adrenaline, 0.9% NaCl
Patients in group SNB received an ultrasound guided SNB (a sub sartorial approach) by a single operator with 10 mls 0.5% bupivacaine. At the end of surgery periarticular knee infiltration of 30 mls 0.5% levobupivacaine + 70 mls 0.9% saline + 0.5 mg adrenaline was performed in a staged fashion by the surgeon, beginning with infiltration of the deep structures on tibial surface at 1mm depth around all exposed tissues, medial and lateral collateral ligament origin, all cut surfaces of extensor mechanism, all cut surface of skin and subcutaneous tissue
NSNB Non Saphenous Nerve BlockProcedure or surgery
Also called Levobupivacaine, Adrenaline, 0.9% NaCl
All patients at the end of surgery received periarticular knee infiltration of 30 mls 0.5% levobupivacaine + 70 mls 0.9% saline + 0.5 mg adrenaline, in a staged fashion by the surgeon, beginning with infiltration of the deep structures on tibial surface at 1mm depth around all exposed tissues, medial and lateral collateral ligament origin, all cut surfaces of extensor mechanism, all cut surface of skin and subcutaneous tissue
| Study group | Role | What they receive |
|---|---|---|
| SNB Saphenous Nerve block | Experimental | Patients received SNB preoperatively at mid thigh level with ultrasound guidance. 10 mls 0.5% bupivacaine was administered for nerve block by the anesthetist. All patients also received peri operative Local Infiltration Analgesia by the surgeon. All patients will receive preoperative oxycontin, peri operative paracetamol and diclofenac. Post operatively all patients received regular paracetamol 1g 6 hourly, Diclofenac sodium 12 hourly and oxycontin 10-20 mg 12 hourly. All patients received standardized spinal block by the same anesthetist, post nerve block for surgery. Receives: Procedure: SNB Saphenous Nerve Block |
| NSNB Non Saphenous Nerve Block | Active comparator | Patients only received Local Infiltration Analgesia. As per protocol all patients received the same pre, peri and post operative analgesia as described in the experimental group. All patients had a standardized spinal block for surgery. Receives: Procedure: NSNB Non Saphenous Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on movement at 24 hours time point post operatively
Measured: 24 hours hours time point
Secondary outcomes (8)
pain on movement at 6 and 12 hour time point
Measured: 6 and 12 hours time points
pain at rest at 6, 12 and 24 hours time points
Measured: 6, 12 and 24 hours time points
Maximum Knee Flexion at 6, 12 and 24 hours time points
Measured: 6, 12 and 24 hours time points
Maximum Straight Leg Raise Test at 6, 12 and 24 hours time points
Measured: 6, 12 and 24 hours time points
Time to First request for rescue analgesia
Measured: 24 hours
Cumulative Opioid consumption in 24 hours
Measured: 24 hours
Cumulative opioid consumption till discharge
Measured: till discharge time
6 Minute walk test
Measured: At 24 hours Post block Conduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cork University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR. Jassim Rauf, Cork University Hospital
- Investigators
- George Shorten, FFARCSI, PhD, Study director, Dept. of Anaesthesia & ICU, Cork University Hospital, Cork, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991288
- Sponsor's protocol ID
- JR-0786-GI
- Status last verified
- Nov 2013
- First submitted
- 17 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Saphenous Nerve Block Improve Analgesia After Total Knee Replacement When Used in Combination With Local Infiltration Analgesia? A Prospective Randomised Double Blinded Trial.
- ClinicalTrials.gov ID
- NCT01991288
- Acronym / sponsor ID
- JR-0786-GI
- Conditions
- Post Operative Pain
- Keywords
- Total Knee Replacement, Bupivacaine, Levobupivacaine, Saphenous Nerve Block, Local Infiltration Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cork University HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 25 Nov 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.
We hypothesize that preoperative saphenous nerve block (SNB) in combination with periarticular local infiltration provides better post operative pain relief (POPR) profile as compared to local infiltration alone
Detailed description
Introduction:
Local infiltration analgesia (LIA) is considered acceptable after total knee replacements (TKR) in terms of analgesia, ease of performance, early mobilization and early hospital discharge . Continuous femoral nerve block has been used to enhance post op pain relief (POPR) for TKR but at the expense of motor blockade . A Sub sartorial approach to saphenous nerve block (SNB) spares the motor block . To date the role of saphenous nerve block for POPR in TKR has not been evaluated.
Methodology:
In order to test this hypothesis, we proposed to carry out a prospective randomized controlled double blinded (surgeon and assessor) trial study. With institutional ethics approval and having obtained written informed consent from each patient, 20 ASA 1 - 3 patients scheduled to undergo TKR under spinal anesthesia +/- sedation were allocated to one of two groups i.e. Group (SNB): patients receiving SNB sub sartorial approach and Group (NSNB): patients not receiving SNB.
Group allocation was determined using computer generated random number tables. Sealed envelopes were opened on the day of the surgery by the attending anesthetist responsible for the care of the recruited patient.
Postoperative period:
Patients were then assessed for pain at rest and on movement on arrival in recovery and then at 6 , 12 and 24 hrs. Visual analogue scale on a 10 cm straight line was used to assess postoperative pain scores as predictive value of post operative analgesia on rest and movement i.e passive flexion of knee to 30 degree . Patients were assessed for any motor block by using maximum tolerable range of active knee flexion (MKF) and maximum range of straight leg raise(MSLR) on arrival in recovery and at 6, 12 and 24 hrs. All patients received regular paracetamol 1g 6 hourly, diclofenac 75 mg 12 hourly, oxycontin 10-20 mg ( depending on age) 12 hourly and oxynorm 10 mg as rescue analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNB Saphenous Nerve block | Experimental | Procedure: SNB Saphenous Nerve BlockPatients received SNB preoperatively at mid thigh level with ultrasound guidance. 10 mls 0.5% bupivacaine was administered for nerve block by the anesthetist. All patients also received peri operative Local Infiltration Analgesia by the surgeon. All patients will receive preoperative oxycontin, peri operative paracetamol and diclofenac. Post operatively all patients received regular paracetamol 1g 6 hourly, Diclofenac sodium 12 hourly and oxycontin 10-20 mg 12 hourly. All patients received standardized spinal block by the same anesthetist, post nerve block for surgery. |
| NSNB Non Saphenous Nerve Block | Active comparator | Procedure: NSNB Non Saphenous Nerve BlockPatients only received Local Infiltration Analgesia. As per protocol all patients received the same pre, peri and post operative analgesia as described in the experimental group. All patients had a standardized spinal block for surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anaesthesia (ASA) Grade I-lll patients Undergoing elective Total Knee Arthroplasty Patients able to consent and understand all the components of the study.
Key exclusion criteria (1 listed)
- Demented patients Patients having bilateral Knee Replacements Patients unable to comprehend the use of pain scales Allergy to any of the medications used in the study Renal dysfunction Coagulation disorders Peptic ulcer disease precluding use of non-steroidal anti-inflammatory drugs (NSAIDs) Patients unable to use regular opioid medication Any chronic pain condition other than osteoarthritis of the knee.
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 |
|---|---|---|
| SNB Saphenous Nerve BlockAlso: Bupivacaine, Levobupivacaine, Adrenaline, 0.9% NaClPatients in group SNB received an ultrasound guided SNB (a sub sartorial approach) by a single operator with 10 mls 0.5% bupivacaine. At the end of surgery periarticular knee infiltration of 30 mls 0.5% levobupivacaine + 70 mls 0.9% saline + 0.5 mg adrenaline was performed in a staged fashion by the surgeon, beginning with infiltration of the deep structures on tibial surface at 1mm depth around all exposed tissues, medial and lateral collateral ligament origin, all cut surfaces of extensor mechanism, all cut surface of skin and subcutaneous tissue | Procedure or surgery | SNB Saphenous Nerve block |
| NSNB Non Saphenous Nerve BlockAlso: Levobupivacaine, Adrenaline, 0.9% NaClAll patients at the end of surgery received periarticular knee infiltration of 30 mls 0.5% levobupivacaine + 70 mls 0.9% saline + 0.5 mg adrenaline, in a staged fashion by the surgeon, beginning with infiltration of the deep structures on tibial surface at 1mm depth around all exposed tissues, medial and lateral collateral ligament origin, all cut surfaces of extensor mechanism, all cut surface of skin and subcutaneous tissue | Procedure or surgery | NSNB Non Saphenous Nerve Block |
Primary outcome
Pain on movement at 24 hours time point post operatively
Time frame: 24 hours hours time point
8 secondary outcomes
pain on movement at 6 and 12 hour time point
Time frame: 6 and 12 hours time points
pain at rest at 6, 12 and 24 hours time points
Time frame: 6, 12 and 24 hours time points
Maximum Knee Flexion at 6, 12 and 24 hours time points
Time frame: 6, 12 and 24 hours time points
Maximum Straight Leg Raise Test at 6, 12 and 24 hours time points
Time frame: 6, 12 and 24 hours time points
Time to First request for rescue analgesia
Time frame: 24 hours
Cumulative Opioid consumption in 24 hours
Time frame: 24 hours
Cumulative opioid consumption till discharge
Time frame: till discharge time
6 Minute walk test
Time frame: At 24 hours Post block Conduction
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 25 Nov 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.
George Shorten, FFARCSI, PhD study director
Dept. of Anaesthesia & ICU, Cork University Hospital, Cork, Ireland
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 SNB Saphenous Nerve Block and NSNB Non Saphenous Nerve Block in people with Post Operative Pain, run by Cork University Hospital at 1 site in Ireland.
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 25 Nov 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 Ireland. 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.
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 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?
Pain on movement at 24 hours time point post operatively (time frame: 24 hours hours time point). 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 25 Nov 2013.