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Duloxetine and pregabalin: High-dose monotherapy or their combination? -A prospective, randomised, triple-blind, parallel-group study of patients with postoperative pain after TKA based on the classification of Central Sensitization Inventory scores

Duloxetine and pregabalin: High-dose monotherapy or their combination? -A prospective, randomised, triple-blind, parallel-group study of patients with postoperative pain after TKA based on the classification of Central Sensitization Inventory scores

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081990
Enrollment
Unknown
Registered
2024-03-18
Start date
2024-03-20
Completion date
Unknown
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoarthritis of the knee

Interventions

group 1:All received 200 mg celecoxib as prophylactic pain control 2 hours before surgery, and all were given 1 mL of a 100-mL mixture containing 2,000 mg of fentanyl as needed after surgery using an
group 2:During the initial 6-week treatment period, patients received 60 mg of duloxetine per day and thereafter, during the 6-week combination/high-dose treatment period, only non-responders (respons
group 3:During the initial 6-week treatment period, patients received 60 mg of duloxetine per day. Thereafter, during the 6-week combination/high-dose treatment period, only non-responders (response r
group 4:During the initial 6-week treatment period, patients received 300 mg of pregabalin daily. Thereafter, during the 6-week combination/high-dose treatment period, only non-responders (response ra
group 5:During the initial 6-week treatment period, patients received 300 mg of pregabalin per day. Thereafter, during the 6-week combination/high-dose treatment period, only non-responders (response

Sponsors

Honghui Hospital, Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Diagnosed with osteoarthritis of the knee through clinical and imaging tests and scheduled to undergo initial total knee replacement; 2) =50 years of age; 3) No barriers to communication; 4) have a physical status of I-III as assessed by the American Society of Anaesthesiologists; 5) Volunteer to participate in the study and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1) other surgical procedures (e.g., major hip, thoracic, or abdominal surgery) within the past year; 2) Previous open surgery on the same side of the knee; 3) have had an intra-articular knee injection or knee arthroscopy within the last three months; 4) planned contralateral TKA surgery or any other surgical procedure during the study period; 5) have a serious preoperative comorbidity that could result in hospitalisation during the study or an illness that would seriously interfere with study participation; 6) have a history of significant peripheral nerve injury; 7) neurological disease or cognitive impairment (e.g., Alzheimer's disease, dementia) that would interfere with the questionnaire; 8) Allergy to or intolerance of duloxetine, pregabalin or anaesthetic drugs; 9) Long-term use of gabapentin or pregabalin (regular use for more than 3 months); 10) Use of duloxetine or other SNRIs, SSRIs, MAOIs, tricyclic antidepressants; 11) Allergy to sulfonamides; 12) History of peptic ulcer or history of bleeding disorders; 13) Impaired hepatic function ((alanine aminotransferase (ALT) or menthionine aminotransferase (AST) >100 IU/L or elevated prothrombin time (International Normalised Ratio (INR)) >1.5), or known cirrhosis or liver transplantation; 14) Severe renal impairment (creatinine clearance less than 30 ml/min), previous renal transplantation or in renal dialysis; 15) Hamilton Depression Scale score >7; 16) History of alcohol or other drug abuse or dependence within 5 years prior to enrolment; 17) History of arrhythmia, heart failure, myocardial infarction or arrhythmia at the time of enrolment; 18) Hyponatraemia (180 mm Hg or diastolic blood pressure >110 mm Hg at the time of enrolment; 20) History of glaucoma (or elevated intraocular pressure), uncontrolled thyroid disease or uncontrolled seizures; 21) Inability to complete the study questionnaire; 22) Patients who refuse randomisation

Design outcomes

Primary

MeasureTime frame
brief pain inventory;Western Ontario and McMaster Universities;CSI;

Secondary

MeasureTime frame
Intermittent and Constant Osteoarthritis Pain;Knee range of motion;SF-36;HAMD;

Countries

China

Contacts

Public ContactXu Chao

Honghui Hospital, Xi'an Jiaotong University

383697196@qq.com+86 158 2961 3411

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026