Total Knee ReplacementPhase 4NCT03901768
Effects of Combined Topical and Systemic Steroid Administrations on Better Early Postoperative Pain Management in Total Knee Arthroplasty
A Phase 4 study testing Dexamethasone and Triamcinolone in people with Total Knee Replacement, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
With the aging of population, osteoarthritis of knees and hips has become major orthopaedic problems in Hong Kong. Osteoarthritis of knees and hips is associated with significant pain problems and functional disability. Total joint replacement is the ultimate surgical procedure to deal with such problems. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Dexamethasone and Triamcinolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteHong Kong
- Study dates
- 26 Apr 2018to 1 Jan 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I-III
- Age 18-80 years old (For patients recruited from the Duchess of Kent Children's Hospital at Sandy Bay, they will also be aged from 18 to 80 years old)
- Scheduled for elective primary unilateral total knee replacement
- Chinese patients
- Able to speak and understand Cantonese
- Able to provide informed oral and written consent
Who cannot join
- Revision total knee replacement
- Single stage bilateral total knee replacement
- Known allergy to opioids, local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors
- History of chronic pain other than chronic knee pain
- History of insulin dependent diabetic mellitus, but not diabetic mellitus on oral hyperglycaemic agents
- History of hepatitis B or C carrier
Show all 22Show fewer
- History of peptic ulcer
- Hx of tuberculosis
- History of immunosuppression
- Daily use of glucocorticoids
- Daily use of strong opioids (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, or meperidine)
- History of severe heart disease (NYHA 2)
- Alcohol or drug abuse
- Impaired renal function, defined as preoperative serum creatinine level over 120 micromol/L
- Pre-existing neurological or muscular disorders
- Psychiatric illness or neurologic or psychiatric diseases potentially influencing pain perception
- Impaired or retarded mental state
- Difficulties in using patient controlled analgesia (PCA)
- Pregnancy
- Local infection
- On immunosuppresants
- Patient refusal
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Orthopaedics and Traumatology, The University of Hong Kong
Hong Kong
Ping Keung Chan, MBBS, +852 2255 4654, ortho@hku.hk
About this study
Official title: Effects of Combined Topical and Systemic Steroid Administrations on Better Early Postoperative Pain Management in Total Knee Arthroplasty: a Prospective Double-blinded Placebo Controlled Randomised Clinical Trial
With the aging of population, osteoarthritis of knees and hips has become major orthopaedic problems in Hong Kong. Osteoarthritis of knees and hips is associated with significant pain problems and functional disability. Total joint replacement is the ultimate surgical procedure to deal with such problems.
However total joint replacement is associated with significant tissue damage and post-operative pain problems, which would affect post-operative recovery and rehabilitation.
Read more
The primary aims of total knee replacement are improvement in functional activities and reducing pain due to degenerated knee joints. However, there are around 20-30% of patients would develop significant pain problems despite uncomplicated total knee replacement. It accounts for major post-operative problems and burdens.
Procedure specific analgesic method with multi-model analgesia technique is well-known to be useful in post-operative pain management, which reduces the post-operative pain score. Despite the use of multi-modal analgesic technique, pain after total joint replacement is still an unsolved issue. It prolongs the recovery period and increases post-operative analgesic consumption.
Dexamethasone is a glucocorticoid which is associated with anti-inflammatory response. It is well known to have prophylaxis effect on post-operative nausea and vomiting. Perioperative single dose of systemic dexamethasone have shown to be useful for reduction in pain and cumulative opioid consumption. Meta-analysis from De Oliveira et al supports that dexamethasone (up to 0.2 mg/kg) is a safe and effective multimodal pain strategy after surgical procedures. However, this dose recommendation is not surgery specific. Recently, one review also supports even higher systemic steroid dose to ameliorate post-operative pain after hip and knee surgery. This is based on 3 RCTs using high dose steroid (125 mg methylpresnisolone and 40mg dexamethasone). However, large-scale safety and dose-finding studies are warranted before final recommendations. In view of these, it is essential to have more RCTs evaluating the optimal dose of steroid for pain management after hip and knee surgery.
Chronic steroid use is known to be associated with infection and gastrointestinal bleeding. It is essential to evaluate the safety profile associated with the use of high dose steroid -- risk of infection, gastrointestinal bleeding and hyperglycaemia etc. Published reviews have not raised concerns with perioperative single-dose administration in surgical patients. For hyperglycemia, P. Hans et al have shown that after the use of 10 mg dexamethasone, blood glucose level was increased in non-diabetic and type 2 diabetic patients undergoing abdominal surgery, in which glucose level and percentage change of glucose level were significant higher in diabetic group with glucose level peaked at around 2 hours after injection. Recent study by Basem B. Abdelmalak et al have shown that there was a comparable dexamethasone-induced hyperglycemic response in the diabetic and non-diabetic groups. Nevertheless, there was dexamethasone-induced hyperglycaemia in both groups. Close monitoring of blood glucose and correction of hyperglycaemia in those patients are recommended.
In previous studies, high-dose dexamethasone has shown to be effective and safe to be administered. The addition of dexamethasone to the multi-model analgesia is associated with anti-inflammatory response, thus extending the analgesic effect period for up to 72 hrs as purposed to 24-48 hrs. However, the recommended dose of dexamethasone is not surgery-specific and needs more studies to define the optimal dose. Therefore, it is essential to have more RCTs which evaluate the optimal dose of steroid for better pain management after hip and knee surgeries.
Investigators have recently performed a study evaluating the effect of high-dose dexemathasone. It is shown that dexamethasone 16mg is effective in managing acute postoperative pain after total knee arthroplasty. Another study have been performed by investigators to show the effectiveness of local application of triamcinolone to surgical sites after total knee arthroplasty.
In view of the above findings, the aim of this study is to compare the effect of intravenous dexamethasone, local application of triamcinolone and combined use of intravenous dexamethasone and local application of triamcinolone after total knee arthroplasty.
- Conditions
- Total Knee Replacement
- Being tested
- Dexamethasone, Triamcinolone, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
a syringe having 4ml of 4mg/ml of dexamethasone is used for intravenous injection.
TriamcinoloneDrug
1ml of 40mg triamcinolone is mixed in the syringes containing solution for intrarticualar local infiltration. The solution is injected intraarticularly.
PlacebosDrug
A syringe having 4ml of saline is used for intravenous injection. 1ml of saline is mixed in the syringes containing solution for intrarticualar local infiltration. The solution is injected intraarticularly.
| Study group | Role | What they receive |
|---|---|---|
| Group dexamethasone | Experimental | A syringe having 4ml of 4mg/ml of dexamethasone is used for intravenous injection Receives: Drug: Dexamethasone |
| Group triamcinolone | Experimental | 1ml of 40mg triamcinolone is mixed in the syringes containing solution for intrarticualar local infiltration. The solution is injected intraarticularly. Receives: Drug: Triamcinolone |
| Group dexamethasone with triamcinolone | Experimental | A syringe having 4ml of 4mg/ml of dexamethasone is used for intravenous injection. 1ml of 40mg triamcinolone is mixed in the syringes containing solution for intrarticualar local infiltration. The solution is injected intraarticularly. Receives: Drug: Dexamethasone; Drug: Triamcinolone |
| Placebo group | Placebo comparator | A syringe having 4ml of saline is used for intravenous injection. 1ml of saline is mixed in the syringes containing solution for intrarticualar local infiltration. The solution is injected intraarticularly. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (rest, moment)
Numeric rating scale is used to assess pain intensity in persons who are able to self report. It ranges from 0 to 10. Pain increases with the number.
Measured: From day 0 to 12 months after surgery
PCA morphine consumption
Number of demands and goods
Measured: From day 0 to the day on which patient was discharged from the hospital, assessed up to day 7
Active and passive ROM of knee (flexion and extension)
Active and passive range of motion of knee (flexion and extension)
Measured: From day 0 to 12 months after surgery
Local Knee function e.g. KSKS
Knee society knee score is a total score which rates the knee joint and its function. Higher score represents better knee recovery. It ranges from 0 to 100. Total score is the sum of subscores. Subscales are pain, passive range of motion, stabilty, fixed flexion contracture, extension lag and alignment. Pain ranges from 0 to 50. Higher score represents milder pain. Passive range of motion ranges from 0 to 25. Higher score represents better recovery. Stability ranges from 0 to 25. Higher score represents better recovery. Fixed flexion contracture ranges from 0 to -15. Lower score represents worse recovery. Extension lag ranges from 0 to -15. Lower score represents worse recovery. Alignment ranges from 0 to -20. Lower score represents worse recovery.
Measured: From day 0 to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start26 Apr 2018
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chan Ping-Keung, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901768
- Sponsor's protocol ID
- UW 18-234
- Status last verified
- Apr 2019
- First submitted
- 29 Mar 2019
- Last updated
- 3 Apr 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.
PubMed 21799397Waldron NH, Jones CA, Gan TJ, Allen TK, Habib AS. Impact of perioperative dexamethasone on postoperative analgesia and side-effects: systematic review and meta-analysis. Br J Anaesth. 2013 Feb;110(2):191-200. doi: 10.1093/bja/aes431. Epub 2012 Dec 5.
PubMed 23220857Lunn TH, Kehlet H. Perioperative glucocorticoids in hip and knee surgery - benefit vs. harm? A review of randomized clinical trials. Acta Anaesthesiol Scand. 2013 Aug;57(7):823-34. doi: 10.1111/aas.12115. Epub 2013 Apr 15.
PubMed 23581549Srinivasa S, Kahokehr AA, Yu TC, Hill AG. Preoperative glucocorticoid use in major abdominal surgery: systematic review and meta-analysis of randomized trials. Ann Surg. 2011 Aug;254(2):183-91. doi: 10.1097/SLA.0b013e3182261118.
PubMed 21694581Salerno A, Hermann R. Efficacy and safety of steroid use for postoperative pain relief. Update and review of the medical literature. J Bone Joint Surg Am. 2006 Jun;88(6):1361-72. doi: 10.2106/JBJS.D.03018.
PubMed 16757774Sauerland S, Nagelschmidt M, Mallmann P, Neugebauer EA. Risks and benefits of preoperative high dose methylprednisolone in surgical patients: a systematic review. Drug Saf. 2000 Nov;23(5):449-61. doi: 10.2165/00002018-200023050-00007.
PubMed 11085349Holte K, Kehlet H. Perioperative single-dose glucocorticoid administration: pathophysiologic effects and clinical implications. J Am Coll Surg. 2002 Nov;195(5):694-712. doi: 10.1016/s1072-7515(02)01491-6. No abstract available.
PubMed 12437261Smeulers NJ, Wierda JM, van den Broek L, Gallandat Huet RC, Hennis PJ. Effects of hypothermic cardiopulmonary bypass on the pharmacodynamics and pharmacokinetics of rocuronium. J Cardiothorac Vasc Anesth. 1995 Dec;9(6):700-5. doi: 10.1016/s1053-0770(05)80232-0.
PubMed 8664462Hans P, Vanthuyne A, Dewandre PY, Brichant JF, Bonhomme V. Blood glucose concentration profile after 10 mg dexamethasone in non-diabetic and type 2 diabetic patients undergoing abdominal surgery. Br J Anaesth. 2006 Aug;97(2):164-70. doi: 10.1093/bja/ael111. Epub 2006 May 12.
PubMed 16698859Abdelmalak BB, Bonilla AM, Yang D, Chowdary HT, Gottlieb A, Lyden SP, Sessler DI. The hyperglycemic response to major noncardiac surgery and the added effect of steroid administration in patients with and without diabetes. Anesth Analg. 2013 May;116(5):1116-1122. doi: 10.1213/ANE.0b013e318288416d. Epub 2013 Apr 4.
PubMed 23558840Bailey IS, Karran SE, Toyn K, Brough P, Ranaboldo C, Karran SJ. Community surveillance of complications after hernia surgery. BMJ. 1992 Feb 22;304(6825):469-71. doi: 10.1136/bmj.304.6825.469.
PubMed 1547415Maldonado CC, Bentley AJ, Mitchell D. A pictorial sleepiness scale based on cartoon faces. Sleep. 2004 May 1;27(3):541-8. doi: 10.1093/sleep/27.3.541.
PubMed 15164912
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Topical and Systemic Steroid Administrations on Better Early Postoperative Pain Management in Total Knee Arthroplasty: a Prospective Double-blinded Placebo Controlled Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03901768
- Acronym / sponsor ID
- UW 18-234
- Conditions
- Total Knee Replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 3 Apr 2019 (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.
With the aging of population, osteoarthritis of knees and hips has become major orthopaedic problems in Hong Kong. Osteoarthritis of knees and hips is associated with significant pain problems and functional disability. Total joint replacement is the ultimate surgical procedure to deal with such problems.
However total joint replacement is associated with significant tissue damage and post-operative pain problems, which would affect post-operative recovery and rehabilitation.
The primary aims of total knee replacement are improvement in functional activities and reducing pain due to degenerated knee joints. However, there are around 20-30% of patients would develop significant pain problems despite uncomplicated total knee replacement. It accounts for major post-operative problems and burdens.
Procedure specific analgesic method with multi-model analgesia technique is well-known to be useful in post-operative pain management, which reduces the post-operative pain score. Despite the use of multi-modal analgesic technique, pain after total joint replacement is still an unsolved issue. It prolongs the recovery period and increases post-operative analgesic consumption.
Dexamethasone is a glucocorticoid which is associated with anti-inflammatory response. It is well known to have prophylaxis effect on post-operative nausea and vomiting. Perioperative single dose of systemic dexamethasone have shown to be useful for reduction in pain and cumulative opioid consumption. Meta-analysis from De Oliveira et al supports that dexamethasone (up to 0.2 mg/kg) is a safe and effective multimodal pain strategy after surgical procedures. However, this dose recommendation is not surgery specific. Recently, one review also supports even higher systemic steroid dose to ameliorate post-operative pain after hip and knee surgery. This is based on 3 RCTs using high dose steroid (125 mg methylpresnisolone and 40mg dexamethasone). However, large-scale safety and dose-finding studies are warranted before final recommendations. In view of these, it is essential to have more RCTs evaluating the optimal dose of steroid for pain management after hip and knee surgery.
Chronic steroid use is known to be associated with infection and gastrointestinal bleeding. It is essential to evaluate the safety profile associated with the use of high dose steroid -- risk of infection, gastrointestinal bleeding and hyperglycaemia etc. Published reviews have not raised concerns with perioperative single-dose administration in surgical patients. For hyperglycemia, P. Hans et al have shown that after the use of 10 mg dexamethasone, blood glucose level was increased in non-diabetic and type 2 diabetic patients undergoing abdominal surgery, in which glucose level and percentage change of glucose level were significant higher in diabetic group with glucose level peaked at around 2 hours after injection. Recent study by Basem B. Abdelmalak et al have shown that there was a comparable dexamethasone-induced hyperglycemic response in the diabetic and non-diabetic groups. Nevertheless, there was dexamethasone-induced hyperglycaemia in both groups. Close monitoring of blood glucose and correction of hyperglycaemia in those patients are recommended.
In previous studies, high-dose dexamethasone has shown to be effective and safe to be administered. The addition of dexamethasone to the multi-model analgesia is associated with anti-inflammatory response, thus extending the analgesic effect period for up to 72 hrs as purposed to 24-48 hrs. However, the recommended dose of dexamethasone is not surgery-specific and needs more studies to define the optimal dose. Therefore, it is essential to have more RCTs which evaluate the optimal dose of steroid for better pain management after hip and knee surgeries.
Investigators have recently performed a study evaluating the effect of high-dose dexemathasone. It is shown that dexamethasone 16mg is effective in managing acute postoperative pain after total knee arthroplasty. Another study have been performed by investigators to show the effectiveness of local application of triamcinolone to surgical sites after total knee arthroplasty.
In view of the above findings, the aim of this study is to compare the effect of intravenous dexamethasone, local application of triamcinolone and combined use of intravenous dexamethasone and local application of triamcinolone after total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group dexamethasone | Experimental | Drug: DexamethasoneA syringe having 4ml of 4mg/ml of dexamethasone is used for intravenous injection |
| Group triamcinolone | Experimental | Drug: Triamcinolone1ml of 40mg triamcinolone is mixed in the syringes containing solution for intrarticualar local infiltration. The solution is injected intraarticularly. |
| Group dexamethasone with triamcinolone | Experimental | Drug: Dexamethasone, Drug: TriamcinoloneA syringe having 4ml of 4mg/ml of dexamethasone is used for intravenous injection. 1ml of 40mg triamcinolone is mixed in the syringes containing solution for intrarticualar local infiltration. The solution is injected intraarticularly. |
| Placebo group | Placebo comparator | Drug: PlacebosA syringe having 4ml of saline is used for intravenous injection. 1ml of saline is mixed in the syringes containing solution for intrarticualar local infiltration. The solution is injected intraarticularly. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ASA I-III
- Age 18-80 years old (For patients recruited from the Duchess of Kent Children's Hospital at Sandy Bay, they will also be aged from 18 to 80 years old)
- Scheduled for elective primary unilateral total knee replacement
- Chinese patients
- Able to speak and understand Cantonese
Key exclusion criteria (22 listed)
- Revision total knee replacement
- Single stage bilateral total knee replacement
- Known allergy to opioids, local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors
- History of chronic pain other than chronic knee pain
- History of insulin dependent diabetic mellitus, but not diabetic mellitus on oral hyperglycaemic agents
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 |
|---|---|---|
| Dexamethasonea syringe having 4ml of 4mg/ml of dexamethasone is used for intravenous injection. | Drug | Group dexamethasone, Group dexamethasone with triamcinolone |
| Triamcinolone1ml of 40mg triamcinolone is mixed in the syringes containing solution for intrarticualar local infiltration. The solution is injected intraarticularly. | Drug | Group dexamethasone with triamcinolone, Group triamcinolone |
| PlacebosA syringe having 4ml of saline is used for intravenous injection. 1ml of saline is mixed in the syringes containing solution for intrarticualar local infiltration. The solution is injected intraarticularly. | Drug | Placebo group |
Primary outcome
Pain (rest, moment)
Time frame: From day 0 to 12 months after surgery
Numeric rating scale is used to assess pain intensity in persons who are able to self report. It ranges from 0 to 10. Pain increases with the number.
PCA morphine consumption
Time frame: From day 0 to the day on which patient was discharged from the hospital, assessed up to day 7
Number of demands and goods
Active and passive ROM of knee (flexion and extension)
Time frame: From day 0 to 12 months after surgery
Active and passive range of motion of knee (flexion and extension)
Local Knee function e.g. KSKS
Time frame: From day 0 to 12 months after surgery
Knee society knee score is a total score which rates the knee joint and its function. Higher score represents better knee recovery. It ranges from 0 to 100. Total score is the sum of subscores. Subscales are pain, passive range of motion, stabilty, fixed flexion contracture, extension lag and alignment. Pain ranges from 0 to 50. Higher score represents milder pain. Passive range of motion ranges from 0 to 25. Higher score represents better recovery. Stability ranges from 0 to 25. Higher score represents better recovery. Fixed flexion contracture ranges from 0 to -15. Lower score represents worse recovery. Extension lag ranges from 0 to -15. Lower score represents worse recovery. Alignment ranges from 0 to -20. Lower score represents worse recovery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Background: PubMed 21799397De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.
- Background: PubMed 23220857Waldron NH, Jones CA, Gan TJ, Allen TK, Habib AS. Impact of perioperative dexamethasone on postoperative analgesia and side-effects: systematic review and meta-analysis. Br J Anaesth. 2013 Feb;110(2):191-200. doi: 10.1093/bja/aes431. Epub 2012 Dec 5.
- Background: PubMed 23581549Lunn TH, Kehlet H. Perioperative glucocorticoids in hip and knee surgery - benefit vs. harm? A review of randomized clinical trials. Acta Anaesthesiol Scand. 2013 Aug;57(7):823-34. doi: 10.1111/aas.12115. Epub 2013 Apr 15.
- Background: PubMed 21694581Srinivasa S, Kahokehr AA, Yu TC, Hill AG. Preoperative glucocorticoid use in major abdominal surgery: systematic review and meta-analysis of randomized trials. Ann Surg. 2011 Aug;254(2):183-91. doi: 10.1097/SLA.0b013e3182261118.
- Background: PubMed 16757774Salerno A, Hermann R. Efficacy and safety of steroid use for postoperative pain relief. Update and review of the medical literature. J Bone Joint Surg Am. 2006 Jun;88(6):1361-72. doi: 10.2106/JBJS.D.03018.
- Background: PubMed 11085349Sauerland S, Nagelschmidt M, Mallmann P, Neugebauer EA. Risks and benefits of preoperative high dose methylprednisolone in surgical patients: a systematic review. Drug Saf. 2000 Nov;23(5):449-61. doi: 10.2165/00002018-200023050-00007.
- Background: PubMed 12437261Holte K, Kehlet H. Perioperative single-dose glucocorticoid administration: pathophysiologic effects and clinical implications. J Am Coll Surg. 2002 Nov;195(5):694-712. doi: 10.1016/s1072-7515(02)01491-6. No abstract available.
- Background: PubMed 8664462Smeulers NJ, Wierda JM, van den Broek L, Gallandat Huet RC, Hennis PJ. Effects of hypothermic cardiopulmonary bypass on the pharmacodynamics and pharmacokinetics of rocuronium. J Cardiothorac Vasc Anesth. 1995 Dec;9(6):700-5. doi: 10.1016/s1053-0770(05)80232-0.
- Background: PubMed 16698859Hans P, Vanthuyne A, Dewandre PY, Brichant JF, Bonhomme V. Blood glucose concentration profile after 10 mg dexamethasone in non-diabetic and type 2 diabetic patients undergoing abdominal surgery. Br J Anaesth. 2006 Aug;97(2):164-70. doi: 10.1093/bja/ael111. Epub 2006 May 12.
- Background: PubMed 23558840Abdelmalak BB, Bonilla AM, Yang D, Chowdary HT, Gottlieb A, Lyden SP, Sessler DI. The hyperglycemic response to major noncardiac surgery and the added effect of steroid administration in patients with and without diabetes. Anesth Analg. 2013 May;116(5):1116-1122. doi: 10.1213/ANE.0b013e318288416d. Epub 2013 Apr 4.
- Background: PubMed 1547415Bailey IS, Karran SE, Toyn K, Brough P, Ranaboldo C, Karran SJ. Community surveillance of complications after hernia surgery. BMJ. 1992 Feb 22;304(6825):469-71. doi: 10.1136/bmj.304.6825.469.
- Background: PubMed 15164912Maldonado CC, Bentley AJ, Mitchell D. A pictorial sleepiness scale based on cartoon faces. Sleep. 2004 May 1;27(3):541-8. doi: 10.1093/sleep/27.3.541.
- Individual participant dataSharing planned: No
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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.
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 Dexamethasone and Triamcinolone in people with Total Knee Replacement, 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 6 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 3 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping Keng Chan, MBBS (+852 9195 1883, cpk464@yahoo.com.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (rest, moment) (time frame: From day 0 to 12 months after surgery). The study lists 4 primary outcomes in all. 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 NCT03901768, which also lists 12 linked publications.
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 3 Apr 2019.