Acute PainPhase 4NCT03597776
Intravenous Lidocaine in Total Knee Replacement
A Phase 4 study testing Lidocaine and Saline in people with Acute Pain, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Osteoarthritis of knees and hips is a common medical problem present in elderly, which poses significant impairment to their mobility, independence, and quality of life. Despite the availability of conservative treatment, such as simple analgesics and physiotherapy, total joint replacement is the only curative option… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Lidocaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 Jan 2019to 14 Sep 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- Primary Elective Total Knee Replacement under Spinal Anaesthesia
Who cannot join
- Single Stage Bilateral Total Knee Replacement
- Revision Total Knee Replacement
- Contraindications to Spinal Anaesthesia or Failed Spinal Anaesthesia
- Allergy to amide local anaesthetics, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS), opioids
- Cardiac Disease: Any degree of Heart Block, Heart Failure
- Neurological: Any Seizure Disorder
Show all 16Show fewer
- Psychiatric illnesses affecting pain perception e.g. severe depression and anxiety disorder
- Alcohol or substance abuse
- Chronic Pain, other than chronic knee pain
- Daily use of strong opioids (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, or meperidine)
- Impaired Renal Function (defined as preoperative serum creatinine level over 200µmol/L)
- Impaired Hepatic Function
- Pregnancy
- Inability to use PCA
- Patient Refusal
- Patients do not understand Cantonese
Trial locations and contacts
1 site in 1 country.
About this study
Osteoarthritis of knees and hips is a common medical problem present in elderly, which poses significant impairment to their mobility, independence, and quality of life. Despite the availability of conservative treatment, such as simple analgesics and physiotherapy, total joint replacement is the only curative option for this disease entity.
The latter, however, is not without risk. A study by Poulakka has demonstrated that patients with poor pain control in the postoperative period were three to ten times more likely to develop chronic pain, which may significantly impair the patients' functional status and quality of life.
Read more
Optimal pain control is therefore essential in facilitating rehabilitation and in preventing long-term morbidities.
Lidocaine [2-(diethylamino)-N-(2,6-dimethylphenyl)acetamide] is an amide local anaesthetic that is characteristically fast in onset and short in duration of action. As such, it has long been used for providing regional anaesthesia for operation, but with limited role in terms of post operative analgesia.
Recently, intravenous infusion of lidocaine has been shown to be safe and effective in reducing post operative pain (resting and dynamic), opioid consumption, and chronic post-surgical pain. The mechanism of action involves both peripheral and central actions. In addition to blockade of the Voltage-gated Sodium Channel of the peripheral nerves, lidocaine also inhibits priming of the PolyMorphoNuclear granulocyte (PMN) by inducing a time-dependent inhibition of intracellular G-protein signalling molecule (Gq); thus reducing release of cytokines and Reactive Oxygen Species Centrally, lidocaine also causes blockade of NMDA receptors and Neurokinin Receptors of the Wide-Dynamic Range Neurons in the dorsal horn of spinal cord; thus reduces glutamate activity.
We therefore hypothesize that the use of intravenous lidocaine may reduce acute pain and improve the range of knee flexion after total knee replacement. Currently, there is strong evidence supporting its use in laparoscopic and open abdominal surgeries. There is, however, a paucity of studies in orthopedic surgeries. To date, there is no randomized controlled trial that studied its effect in total knee replacement.
Read the detailed description
OBJECTIVE:
The aim of this study is to estimate the effectiveness of a preemptive bolus of intravenous lidocaine on reduction in acute pain, improvement on the range of movement, other rehabilitation parameters and functional scoring in the post-operative period after total knee replacement.
DESIGN:
This is a double-blinded, randomized, placebo-controlled trial.
RECRUITMENT \& SAMPLE SIZE:
Over a one-year period, suitable patients will be approached at the pre-admission clinic and in the general ward before their operation. Informed consent will be obtained before enrollment.
The sample size required is calculated to be 45 subjects per group.
PATIENT CHARACTERISTICS:
In order to minimize potential confounding factors, the demographic data of each subject will be collected during preoperative assessment, including: age, gender, duration of preoperative pain duration, preoperative NRS (movement) and NRS (rest). Both active and passive ROM of the knee will be assessed by the attending physiotherapist.
RANDOMIZATION \& BLINDING:
Each subject will be assigned to either Lidocaine Group or Placebo Group. A randomization list will be established by a computer-generated random sequence before the study begins. An envelope containing the group assignment will be prepared, sealed, sequentially numbered, and allocated for each subject. A "blinded" anaesthetist will then prepare lidocaine or saline according to the group assigned for the attending anaesthetist. The subjects, the investigators, and all the parties involved in patient management or data collection will be blinded throughout the study period.
INTERVENTION:
For Lidocaine Group: a bolus of intravenous lidocaine of 2mg/kg over 5 mins will be given before skin incision.
For Placebo Group: Normal Saline of equal volume will be given as bolus before skin incision.
ANAESTHESIA \& ANALGESIA:
(I) PRE-OPERATIVE: Routine preoperative assessment will be taken at the pre-admission clinic or at the general ward; and standard fasting times (6 hours for solid food and 2 hours for clear liquid) will be ordered.
No analgesics or sedatives will be given as pre-medication. Holter machine will be used to document any arrhythmia preoperatively and will be attached to patient till Day 1 postoperatively.
(II) INTRA-OPERATIVE: In addition to continuous ECG monitoring, BP, heart rate and SpO2 will be monitored at no longer than every 5 mins throughout the operation. Signs and symptoms of local anaesthetic toxicity will be assessed at 30 minute intervals.
After establishing at least one patent intravenous cannula and ensuring the monitors are properly applied, Spinal Anaesthesia will be given by the attending anaesthetist under aseptic technique.
The choice of equipment (Whitacre or Quincke Needle), technique (landmark or ultrasound-guided), and approach (midline or paramedical) are at the discretion of the attending anaesthetist.
An intrathecal dose of 2.2-2.6ml 0.5% Heavy Bupivacaine with 15mcg of fentanyl will be given depending on the height of the patient. Vasopressors and intravenous fluids will be given as necessary to keep the patient's blood pressure within 20% of his/her baseline, and to keep the heart rate within normal range.
Bolus of lidocaine or placebo will then be given over 5 minutes before skin incision.
No Sedation will be given during operation in order to facilitate monitoring of systemic toxicity.
No Systemic Analgesics will be given, including Paracetamol, NSAIDS, Ketamine and Opioids.
The surgeries will be performed by the same team of orthopedic surgeons experienced in total knee replacement at a tertiary level university teaching hospital, using standardized surgical techniques. All patients will undergo posterior stabilized knee prosthesis.
Standardized dose of LIA (40ml 0.75% Ropivacaine, 0.5ml 1 in 200,000 Adrenaline, 30mg Ketorolac in 60ml Normal Saline) will be administered by the orthopedic team.
(III) POST-OPERATIVE (PHASE I RECOVERY IN PACU): Upon completion of surgery, the patient will be transferred to PACU for further monitoring for at least 30 minutes. BP, heart rate, and SpO2 will be monitored every 5 minutes in addition to continuous ECG monitoring. Signs and symptoms of local anaesthetic toxicity will be assessed at 15 minute intervals.
Pain will be evaluated every 5 mins using NRS. If the score is greater than 4/10, 2mg morphine will be given intravenously every 5 mins provided the patient has a respiratory rate of > 12/min and a sedation score of <1 until a NRS of < 4/10 is achieved. At which point, a patient-controlled analgesia (PCA) device will be connected to deliver morphine under a standardized regime: 1mg bolus with 5 mins lockout, an hourly maximum of 0.1mg/kg, and no background infusion.
(IV) POST-OPERATIVE (PHASE II RECOVERY IN WARD): Continuous ECG monitoring will continually be applied until Day 1 postoperatively.
Signs and symptoms of local anaesthetic toxicity will be assessed clinically at 1-hour intervals for 12 hours after operation.
BP, heart rate, SpO2, and sedation score will be monitored at 1-hour intervals while on PCA morphine; BP and heart rate will be monitored at 4-hour intervals once PCA morphine is terminated.
Postoperative analgesics will consist of:
PCA Morphine for at least 2 days postoperatively, and will be terminated on postoperative Day 3 once NRS (movement) is less than 4/10 or when 24-hour morphine consumption is less than 10mg.
Standardized analgesic regime, depending on body weight, will be started immediately after operation. For body weight > 50kg, Oral paracetamol 1gram QID, and pregabalin 75mg nocte for 1 week celecoxib 200mg BD for 5 days. For body weight < 50kg, Oral paracetamol 1gram TDS, and pregabalin 50mg nocte for 1 week. celecoxib 200mg daily for 5 days.
0.1mg/kg of intramuscular Morphine will be provided as necessary as rescue analgesic for any breakthrough pain. Intravenous Ondansetron of 0.1mg/kg will be given as necessary for nausea and vomiting.
Diet will be resumed on Postoperative Day 0. The rehabilitation programme will be standardized for all patients and be carried out by the same team of physiotherapists and occupational therapists with the goal of early mobilization on Postoperative Day 0.
- Conditions
- Acute Pain
- Being tested
- Lidocaine, Saline
- Keywords
- intravenous lidocaine, pain, total knee replacement, spinal anaesthesia
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Lignocaine HCL inj 2% B.P.
Bolus of lidocaine will be given over 5 minutes before skin incision
SalineDrug
Bolus of saline will be given over 5 minutes before skin incision
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Group | Experimental | Bolus of intravenous lidocaine of 2mg/kg over 5 mins will be given before skin incision. Receives: Drug: Lidocaine |
| Placebo Group | Placebo comparator | Normal Saline of 2mg/kg over 5 mins will be given as bolus before skin incision Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessed by numerical rating scales (NRS) pain scores
NRS pain scores (from 0-10, where 0 is the least satisfaction and 10 most satisfaction) will be recorded during movement and at rest, by NRS (movement) and NRS (rest) respectively
Measured: at postoperative day 1
Secondary outcomes (4)
Range of motion (ROM) of knee
Active and Passive ROM of knee (flexion and extension) will be recorded.
Measured: until postoperative day 6
Availability of usual activity of knee
Walking Distance, degree of assistance, and need for aids
Measured: until postoperative day 6
Self Care Assessment
Dressing trousers, toileting will be recorded
Measured: until postoperative day 6
Side Effects of PCA Morphine
Nausea, vomiting, dizziness, constipation
Measured: until postoperative day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start3 Jan 2019
- Primary completion10 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chi-Wai Cheung, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597776
- Sponsor's protocol ID
- UW18-276
- Status last verified
- May 2024
- First submitted
- 15 Jul 2018
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Lidocaine in Total Knee Replacement
- ClinicalTrials.gov ID
- NCT03597776
- Acronym / sponsor ID
- UW18-276
- Conditions
- Acute Pain
- Keywords
- intravenous lidocaine, pain, total knee replacement, spinal anaesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 24 Jul 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.
Osteoarthritis of knees and hips is a common medical problem present in elderly, which poses significant impairment to their mobility, independence, and quality of life. Despite the availability of conservative treatment, such as simple analgesics and physiotherapy, total joint replacement is the only curative option for this disease entity.
The latter, however, is not without risk. A study by Poulakka has demonstrated that patients with poor pain control in the postoperative period were three to ten times more likely to develop chronic pain, which may significantly impair the patients' functional status and quality of life.
Optimal pain control is therefore essential in facilitating rehabilitation and in preventing long-term morbidities.
Lidocaine [2-(diethylamino)-N-(2,6-dimethylphenyl)acetamide] is an amide local anaesthetic that is characteristically fast in onset and short in duration of action. As such, it has long been used for providing regional anaesthesia for operation, but with limited role in terms of post operative analgesia.
Recently, intravenous infusion of lidocaine has been shown to be safe and effective in reducing post operative pain (resting and dynamic), opioid consumption, and chronic post-surgical pain. The mechanism of action involves both peripheral and central actions. In addition to blockade of the Voltage-gated Sodium Channel of the peripheral nerves, lidocaine also inhibits priming of the PolyMorphoNuclear granulocyte (PMN) by inducing a time-dependent inhibition of intracellular G-protein signalling molecule (Gq); thus reducing release of cytokines and Reactive Oxygen Species Centrally, lidocaine also causes blockade of NMDA receptors and Neurokinin Receptors of the Wide-Dynamic Range Neurons in the dorsal horn of spinal cord; thus reduces glutamate activity.
We therefore hypothesize that the use of intravenous lidocaine may reduce acute pain and improve the range of knee flexion after total knee replacement. Currently, there is strong evidence supporting its use in laparoscopic and open abdominal surgeries. There is, however, a paucity of studies in orthopedic surgeries. To date, there is no randomized controlled trial that studied its effect in total knee replacement.
Detailed description
OBJECTIVE:
The aim of this study is to estimate the effectiveness of a preemptive bolus of intravenous lidocaine on reduction in acute pain, improvement on the range of movement, other rehabilitation parameters and functional scoring in the post-operative period after total knee replacement.
DESIGN:
This is a double-blinded, randomized, placebo-controlled trial.
RECRUITMENT \& SAMPLE SIZE:
Over a one-year period, suitable patients will be approached at the pre-admission clinic and in the general ward before their operation. Informed consent will be obtained before enrollment.
The sample size required is calculated to be 45 subjects per group.
PATIENT CHARACTERISTICS:
In order to minimize potential confounding factors, the demographic data of each subject will be collected during preoperative assessment, including: age, gender, duration of preoperative pain duration, preoperative NRS (movement) and NRS (rest). Both active and passive ROM of the knee will be assessed by the attending physiotherapist.
RANDOMIZATION \& BLINDING:
Each subject will be assigned to either Lidocaine Group or Placebo Group. A randomization list will be established by a computer-generated random sequence before the study begins. An envelope containing the group assignment will be prepared, sealed, sequentially numbered, and allocated for each subject. A "blinded" anaesthetist will then prepare lidocaine or saline according to the group assigned for the attending anaesthetist. The subjects, the investigators, and all the parties involved in patient management or data collection will be blinded throughout the study period.
INTERVENTION:
For Lidocaine Group: a bolus of intravenous lidocaine of 2mg/kg over 5 mins will be given before skin incision.
For Placebo Group: Normal Saline of equal volume will be given as bolus before skin incision.
ANAESTHESIA \& ANALGESIA:
(I) PRE-OPERATIVE: Routine preoperative assessment will be taken at the pre-admission clinic or at the general ward; and standard fasting times (6 hours for solid food and 2 hours for clear liquid) will be ordered.
No analgesics or sedatives will be given as pre-medication. Holter machine will be used to document any arrhythmia preoperatively and will be attached to patient till Day 1 postoperatively.
(II) INTRA-OPERATIVE: In addition to continuous ECG monitoring, BP, heart rate and SpO2 will be monitored at no longer than every 5 mins throughout the operation. Signs and symptoms of local anaesthetic toxicity will be assessed at 30 minute intervals.
After establishing at least one patent intravenous cannula and ensuring the monitors are properly applied, Spinal Anaesthesia will be given by the attending anaesthetist under aseptic technique.
The choice of equipment (Whitacre or Quincke Needle), technique (landmark or ultrasound-guided), and approach (midline or paramedical) are at the discretion of the attending anaesthetist.
An intrathecal dose of 2.2-2.6ml 0.5% Heavy Bupivacaine with 15mcg of fentanyl will be given depending on the height of the patient. Vasopressors and intravenous fluids will be given as necessary to keep the patient's blood pressure within 20% of his/her baseline, and to keep the heart rate within normal range.
Bolus of lidocaine or placebo will then be given over 5 minutes before skin incision.
No Sedation will be given during operation in order to facilitate monitoring of systemic toxicity.
No Systemic Analgesics will be given, including Paracetamol, NSAIDS, Ketamine and Opioids.
The surgeries will be performed by the same team of orthopedic surgeons experienced in total knee replacement at a tertiary level university teaching hospital, using standardized surgical techniques. All patients will undergo posterior stabilized knee prosthesis.
Standardized dose of LIA (40ml 0.75% Ropivacaine, 0.5ml 1 in 200,000 Adrenaline, 30mg Ketorolac in 60ml Normal Saline) will be administered by the orthopedic team.
(III) POST-OPERATIVE (PHASE I RECOVERY IN PACU): Upon completion of surgery, the patient will be transferred to PACU for further monitoring for at least 30 minutes. BP, heart rate, and SpO2 will be monitored every 5 minutes in addition to continuous ECG monitoring. Signs and symptoms of local anaesthetic toxicity will be assessed at 15 minute intervals.
Pain will be evaluated every 5 mins using NRS. If the score is greater than 4/10, 2mg morphine will be given intravenously every 5 mins provided the patient has a respiratory rate of > 12/min and a sedation score of <1 until a NRS of < 4/10 is achieved. At which point, a patient-controlled analgesia (PCA) device will be connected to deliver morphine under a standardized regime: 1mg bolus with 5 mins lockout, an hourly maximum of 0.1mg/kg, and no background infusion.
(IV) POST-OPERATIVE (PHASE II RECOVERY IN WARD): Continuous ECG monitoring will continually be applied until Day 1 postoperatively.
Signs and symptoms of local anaesthetic toxicity will be assessed clinically at 1-hour intervals for 12 hours after operation.
BP, heart rate, SpO2, and sedation score will be monitored at 1-hour intervals while on PCA morphine; BP and heart rate will be monitored at 4-hour intervals once PCA morphine is terminated.
Postoperative analgesics will consist of:
PCA Morphine for at least 2 days postoperatively, and will be terminated on postoperative Day 3 once NRS (movement) is less than 4/10 or when 24-hour morphine consumption is less than 10mg.
Standardized analgesic regime, depending on body weight, will be started immediately after operation. For body weight > 50kg, Oral paracetamol 1gram QID, and pregabalin 75mg nocte for 1 week celecoxib 200mg BD for 5 days. For body weight < 50kg, Oral paracetamol 1gram TDS, and pregabalin 50mg nocte for 1 week. celecoxib 200mg daily for 5 days.
0.1mg/kg of intramuscular Morphine will be provided as necessary as rescue analgesic for any breakthrough pain. Intravenous Ondansetron of 0.1mg/kg will be given as necessary for nausea and vomiting.
Diet will be resumed on Postoperative Day 0. The rehabilitation programme will be standardized for all patients and be carried out by the same team of physiotherapists and occupational therapists with the goal of early mobilization on Postoperative Day 0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Group | Experimental | Drug: LidocaineBolus of intravenous lidocaine of 2mg/kg over 5 mins will be given before skin incision. |
| Placebo Group | Placebo comparator | Drug: SalineNormal Saline of 2mg/kg over 5 mins will be given as bolus before skin incision |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-III
- Primary Elective Total Knee Replacement under Spinal Anaesthesia
Key exclusion criteria (16 listed)
- Single Stage Bilateral Total Knee Replacement
- Revision Total Knee Replacement
- Contraindications to Spinal Anaesthesia or Failed Spinal Anaesthesia
- Allergy to amide local anaesthetics, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS), opioids
- Cardiac Disease: Any degree of Heart Block, Heart Failure
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 |
|---|---|---|
| LidocaineAlso: Lignocaine HCL inj 2% B.P.Bolus of lidocaine will be given over 5 minutes before skin incision | Drug | Lidocaine Group |
| SalineBolus of saline will be given over 5 minutes before skin incision | Drug | Placebo Group |
Primary outcome
Pain assessed by numerical rating scales (NRS) pain scores
Time frame: at postoperative day 1
NRS pain scores (from 0-10, where 0 is the least satisfaction and 10 most satisfaction) will be recorded during movement and at rest, by NRS (movement) and NRS (rest) respectively
4 secondary outcomes
Range of motion (ROM) of knee
Time frame: until postoperative day 6
Availability of usual activity of knee
Time frame: until postoperative day 6
Self Care Assessment
Time frame: until postoperative day 6
Side Effects of PCA Morphine
Time frame: until postoperative day 6
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 16 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lidocaine and Saline in people with Acute Pain, run by The University of Hong Kong at 1 site in Hong Kong.
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 2 inclusion and 16 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 16 May 2024. 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 Hong Kong. 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.
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 assessed by numerical rating scales (NRS) pain scores (time frame: at postoperative day 1). 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 16 May 2024.