Arthroplasty ComplicationsPhase 4NCT04653415
Large Doses of Methylprednisolone Combined With Gabapentin in Total Knee Arthroplasty
A Phase 4 study testing Gabapentin 300mg, Methylprednisolone 125 mg and Tablet in people with Arthroplasty Complications and Knee Osteoarthritis, run by Jagiellonian University at 1 site in Poland.
Trial summary
The aim of the study was to assess whether administration of gabapentin and methylprednisolone as "pre-emptive analgesia" in a group of patients above 65 years of age would be effective in complex pain management therapy following total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Arthroplasty Complications, Knee Osteoarthritis, Pain, Postoperative
- What is being tested?
- Gabapentin 300mg, Methylprednisolone 125 mg and Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2019to 1 May 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients over 65 years old operated on unilateral total knee arthroplasty
Who cannot join
- diabetes type 1 and 2,
- CRP levels above normal values (≥5 mg/l),
- chronic steroid treatment,
- peptic ulcers treated in the past 30 days,
- chronic pain in the course of gonarthrosis,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Pre-emptive Large Doses of Methylprednisolone Combined With Gabapentin on Pain Treatment and Convalescence After Total Knee Arthroplasty in Elderly: A Double-blind Randomized Study
The aim of the study was to assess whether administration of gabapentin and methylprednisolone as "pre-emptive analgesia" in a group of patients above 65 years of age would be effective in complex pain management therapy following total knee arthroplasty (TKA). For the study investigators will qualify one hundred seventy, above 65 years old patients. The participants will be double-blind randomized into two groups: the study and controls The study group will receive as "pre-emptive" analgesia a single dose of 300 mg oral gabapentin and 125 mg intravenous methylprednisolone, while the others placebo. Perioperatively, all the patients will receive opioid and nonopioid analgesic agents calculated for 1 kg of body weight. Investigators will measure the levels of inflammatory markers (leukocytosis, C-reactive protein - CRP), pain intensity level at rest (numerical rating scale - NRS), the life parameters and all complications.
Read the detailed description
The aim of the study was to assess whether administration of gabapentin and methylprednisolone as "pre-emptive analgesia" in a group of patients above 65 years of age would be effective in complex pain management therapy following total knee arthroplasty (TKA).170 patients operated on due to unilateral TKA will be double-blinded randomized into two groups: the study and the controls. Exclusion criteria are: clinical situation that 1/ restricted glucocorticoid administration: diabetes type 1 and 2, CRP levels above normal values (≥5 mg/l), chronic steroid treatment, peptic ulcers treated in the past 30 days and 2/and the chronic pain in the course of gonarthrosis, high intensity requiring use opioids.
The participants of the study will be subjected to the standardized procedure of subarachnoid anesthesia with subsequent unilateral femoral nerve block at the operated side, followed by the surgical procedure - unilateral TKA. The study group will receive as "pre-emptive" analgesia a single dose of 300 mg oral gabapentin and 125 mg intravenous methylprednisolone, while the others placebo. Prior to anesthesia induction, the patients receive: anti-infection prophylactics intravenous cephazolin 2.0 g, for hemostasis control - tranexamic acid 1.0 g, an anti-emetic agent - ondansetron 8 mg. Fluid supply (crystalloids) will be standardized: 12 ml/kg in the first hour of surgery and 6 ml/kg in the following hours, packed red blood cells if blood loss exceeded 600 ml and hemoglobin concentration <10g/l during the time of operation. Pain management will be carried out based on the results of the NRS scales at rest. Every 6 hours NRS will be checked and intravenous PCA (patient-controlled analgesia) oxycodone hydrochloride, if pain was ≥4 points NRS or intravenous paracetamol, metamizole, if the pain was 2 - 4 NRS points will be administered, all pain medications will be calculated for 1 kg of body weight. In keeping with the ERAS (Enhanced Recovery After Surgery) protocol, on the day of surgery the patients will receive orally fluids and meals, will be mobilized and rehabilitated.
The study was approved by the institutional review board (nr 1072.6120.11.2020). Oral and written informed consent to participate in the study will be collected from all participants of the study. The statistical analysis of the groups will be performed to asess the demographic dates, life parameters, general condition in keeping with the ASA (American Society of Anesthesiology), POSSUM (Physiologic and Operative Severity Score for the enUmeration of Mortality and Morbidity) score, total dose of analgesic medications administered parenterally calculated for 1 kg of body mass in response to value of NRS at rest on day 0, time of administration the first dose, and duration of peripheral nerve block. On the day of surgery and on subsequent days, determinations will be made of glycemia levels and inflammatory markers: C-reactive protein (CRP) and leukocytosis levels.
- Conditions
- Arthroplasty Complications, Knee Osteoarthritis, Pain, Postoperative, Perioperative Complication
- Being tested
- Gabapentin 300mg, Methylprednisolone 125 mg, Tablet, Normal Saline 10 mL Injection
- Keywords
- total knee arthroplasty, pre-emptive analgesia, methylprednisolone, gabapentin, opioid dose, pain intensity, infection rate
- Medical subject headings
- Osteoarthritis, Knee, Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin 300mgDrug
The study group will receive as "pre-emptive" analgesia a single dose of 300 mg oral gabapentin and 125 mg intravenous methylprednisolone.
Methylprednisolone 125 mgDrug
The study group will receive as "pre-emptive" analgesia a single dose of 300 mg oral gabapentin and 125 mg intravenous methylprednisolone.
TabletDrug
The controls group will receive placebo orally - a tablet without any pharmacological properties, intravenously - normal saline solution
Normal Saline 10 mL InjectionDrug
The controls group will receive placebo orally - a tablet without any pharmacological properties, intravenously - normal saline solution
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Active comparator | The study group will receive as "pre-emptive" analgesia a single dose of 300 mg oral gabapentin and 125 mg intravenous methylprednisolone. Receives: Drug: Gabapentin 300mg; Drug: Methylprednisolone 125 mg |
| Controls group | Placebo comparator | The controls group will receive placebo orally - a tablet without any pharmacological properties, intravenously - saline solution. Receives: Drug: Tablet; Drug: Normal Saline 10 mL Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity assessed by NRS
The level of postoperative pain measured in the numerical rating scale (NRS) at rest (minimum 0 - no pain, maximum 10 - the maximum of pain).
Measured: change in every 6 hours on day 0
the dose of parenteral analgesics agents
Dose of oxycodone hydrochloride in mg/kg body weight, paracetamol in mg/kg body weight, metamizole in g/kg body weight
Measured: 24 hours
C-reactive protein (CRP) level
C-reactive protein (CRP) level measured in mg/l
Measured: change in 0,1,2,3 days after surgery
Leukocytosis level
Leukocytosis level measured in µL
Measured: change in 0,1,2,3 days after surgery
Adverse effects
The occurrence of adverse effects that would delay early rehabilitation, possible complication development, perioperative mortality to the POSSUM scale, comorbidities
Measured: 0 day after surgery
Adverse effects
The occurrence of adverse effects that would delay early rehabilitation, possible complication development, perioperative mortality to the POSSUM scale, comorbidities
Measured: 1 day after surgery
Adverse effects
The occurrence of adverse effects that would delay early rehabilitation, possible complication development, perioperative mortality to the POSSUM scale, comorbidities
Measured: 2 day after surgery
Adverse effects
The occurrence of adverse effects that would delay early rehabilitation, possible complication development, perioperative mortality to the POSSUM scale, comorbidities
Measured: 3 day after surgery
Adverse effects
The occurrence of adverse effects that would delay early rehabilitation, possible complication development, perioperative mortality to the POSSUM scale, comorbidities
Measured: 14 day after surgery
Secondary outcomes (2)
Duration of femoral nerve blockade
The time of femoral nerve block
Measured: on the day of surgery
Blood glucose level
The level of glucose in blood in mmol/l
Measured: change in 0,1,2,3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Jun 2019
- Primary completion1 Jan 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty ComplicationsStudies 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
- Model description
- two groups: the study and controls
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henryk Liszka, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653415
- Sponsor's protocol ID
- 1072.6120.11.2020
- Status last verified
- Nov 2020
- First submitted
- 21 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
PubMed 23392233Lamplot JD, Wagner ER, Manning DW. Multimodal pain management in total knee arthroplasty: a prospective randomized controlled trial. J Arthroplasty. 2014 Feb;29(2):329-34. doi: 10.1016/j.arth.2013.06.005. Epub 2013 Jul 11.
PubMed 23850410Kehlet H, Lindberg-Larsen V. High-dose glucocorticoid before hip and knee arthroplasty: To use or not to use-that's the question. Acta Orthop. 2018 Oct;89(5):477-479. doi: 10.1080/17453674.2018.1475177. Epub 2018 May 21. No abstract available.
PubMed 29781366Luna IE, Kehlet H, Petersen MA, Aasvang EK. Clinical, nociceptive and psychological profiling to predict acute pain after total knee arthroplasty. Acta Anaesthesiol Scand. 2017 Jul;61(6):676-687. doi: 10.1111/aas.12899. Epub 2017 May 16.
PubMed 28508511Jorgensen CC, Pitter FT, Kehlet H; Lundbeck Foundation Center for Fast-track Hip and Knee Replacement Collaborative Group. Safety aspects of preoperative high-dose glucocorticoid in primary total knee replacement. Br J Anaesth. 2017 Aug 1;119(2):267-275. doi: 10.1093/bja/aex190.
PubMed 28854533Hartman J, Khanna V, Habib A, Farrokhyar F, Memon M, Adili A. Perioperative systemic glucocorticoids in total hip and knee arthroplasty: A systematic review of outcomes. J Orthop. 2017 Apr 12;14(2):294-301. doi: 10.1016/j.jor.2017.03.012. eCollection 2017 Jun.
PubMed 28442852Lindberg-Larsen V, Ostrowski SR, Lindberg-Larsen M, Rovsing ML, Johansson PI, Kehlet H. The effect of pre-operative methylprednisolone on early endothelial damage after total knee arthroplasty: a randomised, double-blind, placebo-controlled trial. Anaesthesia. 2017 Oct;72(10):1217-1224. doi: 10.1111/anae.13983. Epub 2017 Jul 26.
PubMed 28744857Gadek A, Liszka H, Zajac M. The effect of pre-operative high doses of methylprednisolone on pain management and convalescence after total hip replacement in elderly: a double-blind randomized study. Int Orthop. 2021 Apr;45(4):857-863. doi: 10.1007/s00264-020-04802-8. Epub 2020 Sep 17.
PubMed 32940751Lee JK, Chung KS, Choi CH. The effect of a single dose of preemptive pregabalin administered with COX-2 inhibitor: a trial in total knee arthroplasty. J Arthroplasty. 2015 Jan;30(1):38-42. doi: 10.1016/j.arth.2014.04.004. Epub 2014 Apr 13.
PubMed 24851793Lubis AMT, Rawung RBV, Tantri AR. Preemptive Analgesia in Total Knee Arthroplasty: Comparing the Effects of Single Dose Combining Celecoxib with Pregabalin and Repetition Dose Combining Celecoxib with Pregabalin: Double-Blind Controlled Clinical Trial. Pain Res Treat. 2018 Aug 7;2018:3807217. doi: 10.1155/2018/3807217. eCollection 2018.
PubMed 30174951Osinski T, Bekka S, Regnaux JP, Fletcher D, Martinez V. Functional recovery after knee arthroplasty with regional analgesia: A systematic review and meta-analysis of randomised controlled trials. Eur J Anaesthesiol. 2019 Jun;36(6):418-426. doi: 10.1097/EJA.0000000000000983.
PubMed 30950899Berg U, BuLow E, Sundberg M, Rolfson O. No increase in readmissions or adverse events after implementation of fast-track program in total hip and knee replacement at 8 Swedish hospitals: An observational before-and-after study of 14,148 total joint replacements 2011-2015. Acta Orthop. 2018 Oct;89(5):522-527. doi: 10.1080/17453674.2018.1492507. Epub 2018 Jul 9.
PubMed 29985681Pamilo KJ, Torkki P, Peltola M, Pesola M, Remes V, Paloneva J. Fast-tracking for total knee replacement reduces use of institutional care without compromising quality. Acta Orthop. 2018 Apr;89(2):184-189. doi: 10.1080/17453674.2017.1399643. Epub 2017 Nov 21.
PubMed 29160123Shen S, Gao Z, Liu J. The efficacy and safety of methylprednisolone for pain control after total knee arthroplasty: A meta-analysis of randomized controlled trials. Int J Surg. 2018 Sep;57:91-100. doi: 10.1016/j.ijsu.2018.07.009. Epub 2018 Aug 16.
PubMed 30120990Lei Y, Xie J, Xu B, Xie X, Huang Q, Pei F. The efficacy and safety of multiple-dose intravenous tranexamic acid on blood loss following total knee arthroplasty: a randomized controlled trial. Int Orthop. 2017 Oct;41(10):2053-2059. doi: 10.1007/s00264-017-3519-x. Epub 2017 May 31.
PubMed 28567578
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pre-emptive Large Doses of Methylprednisolone Combined With Gabapentin on Pain Treatment and Convalescence After Total Knee Arthroplasty in Elderly: A Double-blind Randomized Study
- ClinicalTrials.gov ID
- NCT04653415
- Acronym / sponsor ID
- 1072.6120.11.2020
- Conditions
- Arthroplasty Complications, Knee Osteoarthritis, Pain, Postoperative, Perioperative Complication
- Keywords
- total knee arthroplasty, pre-emptive analgesia, methylprednisolone, gabapentin, opioid dose, pain intensity, infection rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 4 Dec 2020 (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.
The aim of the study was to assess whether administration of gabapentin and methylprednisolone as "pre-emptive analgesia" in a group of patients above 65 years of age would be effective in complex pain management therapy following total knee arthroplasty (TKA). For the study investigators will qualify one hundred seventy, above 65 years old patients. The participants will be double-blind randomized into two groups: the study and controls The study group will receive as "pre-emptive" analgesia a single dose of 300 mg oral gabapentin and 125 mg intravenous methylprednisolone, while the others placebo. Perioperatively, all the patients will receive opioid and nonopioid analgesic agents calculated for 1 kg of body weight. Investigators will measure the levels of inflammatory markers (leukocytosis, C-reactive protein - CRP), pain intensity level at rest (numerical rating scale - NRS), the life parameters and all complications.
Detailed description
The aim of the study was to assess whether administration of gabapentin and methylprednisolone as "pre-emptive analgesia" in a group of patients above 65 years of age would be effective in complex pain management therapy following total knee arthroplasty (TKA).170 patients operated on due to unilateral TKA will be double-blinded randomized into two groups: the study and the controls. Exclusion criteria are: clinical situation that 1/ restricted glucocorticoid administration: diabetes type 1 and 2, CRP levels above normal values (≥5 mg/l), chronic steroid treatment, peptic ulcers treated in the past 30 days and 2/and the chronic pain in the course of gonarthrosis, high intensity requiring use opioids.
The participants of the study will be subjected to the standardized procedure of subarachnoid anesthesia with subsequent unilateral femoral nerve block at the operated side, followed by the surgical procedure - unilateral TKA. The study group will receive as "pre-emptive" analgesia a single dose of 300 mg oral gabapentin and 125 mg intravenous methylprednisolone, while the others placebo. Prior to anesthesia induction, the patients receive: anti-infection prophylactics intravenous cephazolin 2.0 g, for hemostasis control - tranexamic acid 1.0 g, an anti-emetic agent - ondansetron 8 mg. Fluid supply (crystalloids) will be standardized: 12 ml/kg in the first hour of surgery and 6 ml/kg in the following hours, packed red blood cells if blood loss exceeded 600 ml and hemoglobin concentration <10g/l during the time of operation. Pain management will be carried out based on the results of the NRS scales at rest. Every 6 hours NRS will be checked and intravenous PCA (patient-controlled analgesia) oxycodone hydrochloride, if pain was ≥4 points NRS or intravenous paracetamol, metamizole, if the pain was 2 - 4 NRS points will be administered, all pain medications will be calculated for 1 kg of body weight. In keeping with the ERAS (Enhanced Recovery After Surgery) protocol, on the day of surgery the patients will receive orally fluids and meals, will be mobilized and rehabilitated.
The study was approved by the institutional review board (nr 1072.6120.11.2020). Oral and written informed consent to participate in the study will be collected from all participants of the study. The statistical analysis of the groups will be performed to asess the demographic dates, life parameters, general condition in keeping with the ASA (American Society of Anesthesiology), POSSUM (Physiologic and Operative Severity Score for the enUmeration of Mortality and Morbidity) score, total dose of analgesic medications administered parenterally calculated for 1 kg of body mass in response to value of NRS at rest on day 0, time of administration the first dose, and duration of peripheral nerve block. On the day of surgery and on subsequent days, determinations will be made of glycemia levels and inflammatory markers: C-reactive protein (CRP) and leukocytosis levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- two groups: the study and controls
| Arm | Type | Receives |
|---|---|---|
| Study Group | Active comparator | Drug: Gabapentin 300mg, Drug: Methylprednisolone 125 mgThe study group will receive as "pre-emptive" analgesia a single dose of 300 mg oral gabapentin and 125 mg intravenous methylprednisolone. |
| Controls group | Placebo comparator | Drug: Tablet, Drug: Normal Saline 10 mL InjectionThe controls group will receive placebo orally - a tablet without any pharmacological properties, intravenously - saline solution. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- patients over 65 years old operated on unilateral total knee arthroplasty
Key exclusion criteria (5 listed)
- diabetes type 1 and 2,
- CRP levels above normal values (≥5 mg/l),
- chronic steroid treatment,
- peptic ulcers treated in the past 30 days,
- chronic pain in the course of gonarthrosis,
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 |
|---|---|---|
| Gabapentin 300mgThe study group will receive as "pre-emptive" analgesia a single dose of 300 mg oral gabapentin and 125 mg intravenous methylprednisolone. | Drug | Study Group |
| Methylprednisolone 125 mgThe study group will receive as "pre-emptive" analgesia a single dose of 300 mg oral gabapentin and 125 mg intravenous methylprednisolone. | Drug | Study Group |
| TabletThe controls group will receive placebo orally - a tablet without any pharmacological properties, intravenously - normal saline solution | Drug | Controls group |
| Normal Saline 10 mL InjectionThe controls group will receive placebo orally - a tablet without any pharmacological properties, intravenously - normal saline solution | Drug | Controls group |
Primary outcome
Pain intensity assessed by NRS
Time frame: change in every 6 hours on day 0
The level of postoperative pain measured in the numerical rating scale (NRS) at rest (minimum 0 - no pain, maximum 10 - the maximum of pain).
the dose of parenteral analgesics agents
Time frame: 24 hours
Dose of oxycodone hydrochloride in mg/kg body weight, paracetamol in mg/kg body weight, metamizole in g/kg body weight
C-reactive protein (CRP) level
Time frame: change in 0,1,2,3 days after surgery
C-reactive protein (CRP) level measured in mg/l
Leukocytosis level
Time frame: change in 0,1,2,3 days after surgery
Leukocytosis level measured in µL
Adverse effects
Time frame: 0 day after surgery
The occurrence of adverse effects that would delay early rehabilitation, possible complication development, perioperative mortality to the POSSUM scale, comorbidities
Adverse effects
Time frame: 1 day after surgery
The occurrence of adverse effects that would delay early rehabilitation, possible complication development, perioperative mortality to the POSSUM scale, comorbidities
Adverse effects
Time frame: 2 day after surgery
The occurrence of adverse effects that would delay early rehabilitation, possible complication development, perioperative mortality to the POSSUM scale, comorbidities
Adverse effects
Time frame: 3 day after surgery
The occurrence of adverse effects that would delay early rehabilitation, possible complication development, perioperative mortality to the POSSUM scale, comorbidities
Adverse effects
Time frame: 14 day after surgery
The occurrence of adverse effects that would delay early rehabilitation, possible complication development, perioperative mortality to the POSSUM scale, comorbidities
2 secondary outcomes
Duration of femoral nerve blockade
Time frame: on the day of surgery
Blood glucose level
Time frame: change in 0,1,2,3 days after surgery
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 4 Dec 2020.
- Background: PubMed 23392233Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
- Background: PubMed 23850410Lamplot JD, Wagner ER, Manning DW. Multimodal pain management in total knee arthroplasty: a prospective randomized controlled trial. J Arthroplasty. 2014 Feb;29(2):329-34. doi: 10.1016/j.arth.2013.06.005. Epub 2013 Jul 11.
- Background: PubMed 29781366Kehlet H, Lindberg-Larsen V. High-dose glucocorticoid before hip and knee arthroplasty: To use or not to use-that's the question. Acta Orthop. 2018 Oct;89(5):477-479. doi: 10.1080/17453674.2018.1475177. Epub 2018 May 21. No abstract available.
- Background: PubMed 28508511Luna IE, Kehlet H, Petersen MA, Aasvang EK. Clinical, nociceptive and psychological profiling to predict acute pain after total knee arthroplasty. Acta Anaesthesiol Scand. 2017 Jul;61(6):676-687. doi: 10.1111/aas.12899. Epub 2017 May 16.
- Background: PubMed 28854533Jorgensen CC, Pitter FT, Kehlet H; Lundbeck Foundation Center for Fast-track Hip and Knee Replacement Collaborative Group. Safety aspects of preoperative high-dose glucocorticoid in primary total knee replacement. Br J Anaesth. 2017 Aug 1;119(2):267-275. doi: 10.1093/bja/aex190.
- Background: PubMed 28442852Hartman J, Khanna V, Habib A, Farrokhyar F, Memon M, Adili A. Perioperative systemic glucocorticoids in total hip and knee arthroplasty: A systematic review of outcomes. J Orthop. 2017 Apr 12;14(2):294-301. doi: 10.1016/j.jor.2017.03.012. eCollection 2017 Jun.
- Background: PubMed 28744857Lindberg-Larsen V, Ostrowski SR, Lindberg-Larsen M, Rovsing ML, Johansson PI, Kehlet H. The effect of pre-operative methylprednisolone on early endothelial damage after total knee arthroplasty: a randomised, double-blind, placebo-controlled trial. Anaesthesia. 2017 Oct;72(10):1217-1224. doi: 10.1111/anae.13983. Epub 2017 Jul 26.
- Background: PubMed 32940751Gadek A, Liszka H, Zajac M. The effect of pre-operative high doses of methylprednisolone on pain management and convalescence after total hip replacement in elderly: a double-blind randomized study. Int Orthop. 2021 Apr;45(4):857-863. doi: 10.1007/s00264-020-04802-8. Epub 2020 Sep 17.
- Background: PubMed 24851793Lee JK, Chung KS, Choi CH. The effect of a single dose of preemptive pregabalin administered with COX-2 inhibitor: a trial in total knee arthroplasty. J Arthroplasty. 2015 Jan;30(1):38-42. doi: 10.1016/j.arth.2014.04.004. Epub 2014 Apr 13.
- Background: PubMed 30174951Lubis AMT, Rawung RBV, Tantri AR. Preemptive Analgesia in Total Knee Arthroplasty: Comparing the Effects of Single Dose Combining Celecoxib with Pregabalin and Repetition Dose Combining Celecoxib with Pregabalin: Double-Blind Controlled Clinical Trial. Pain Res Treat. 2018 Aug 7;2018:3807217. doi: 10.1155/2018/3807217. eCollection 2018.
- Background: PubMed 30950899Osinski T, Bekka S, Regnaux JP, Fletcher D, Martinez V. Functional recovery after knee arthroplasty with regional analgesia: A systematic review and meta-analysis of randomised controlled trials. Eur J Anaesthesiol. 2019 Jun;36(6):418-426. doi: 10.1097/EJA.0000000000000983.
- Background: PubMed 29985681Berg U, BuLow E, Sundberg M, Rolfson O. No increase in readmissions or adverse events after implementation of fast-track program in total hip and knee replacement at 8 Swedish hospitals: An observational before-and-after study of 14,148 total joint replacements 2011-2015. Acta Orthop. 2018 Oct;89(5):522-527. doi: 10.1080/17453674.2018.1492507. Epub 2018 Jul 9.
- 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.
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 Gabapentin 300mg, Methylprednisolone 125 mg and Tablet in people with Arthroplasty Complications and Knee Osteoarthritis, run by Jagiellonian University at 1 site in Poland.
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 5 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 4 Dec 2020. 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 Poland. 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 intensity assessed by NRS (time frame: change in every 6 hours on day 0). The study lists 9 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 NCT04653415, which also lists 15 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 4 Dec 2020.