Does a combination containing morphine and dexamethasone reduce pain after knee replacement surgery?
| ISRCTN | ISRCTN25027558 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25027558 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | CTR20181569 |
| Sponsor | First Affiliated Hospital of Dalian Medical University |
| Funder | First Affiliated Hospital of Dalian Medical University |
- Submission date
- 22/01/2022
- Registration date
- 27/02/2022
- Last edited
- 25/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Total knee arthroplasty (TKA) is surgery to replace the knee joint with an artificial joint. It is considered one of the most successful surgeries with satisfying outcomes, including restored joint movement and significantly reduced pain over time. Patients undergoing TKA typically experience severe pain after surgery, which slows recovery and increases the hospital stay and cost. Injection of a drug cocktail into the joint is a practical and effective pain management strategy after knee and hip surgery. There is no gold-standard cocktail and the proper dosage and composition of the injection cocktail have not been agreed upon. The aim of this study is to evaluate the pain-reducing effectiveness and safety of a morphine and dexamethasone-containing cocktail treatment in patients undergoing total knee arthroplasty.
Who can participate?
Patients aged 50–70 years scheduled for TKA
What does the study involve?
Participants are asked to join this study during hospitalization. They are randomly allocated to one of three groups. Group I patients are injected with morphine, dexamethasone, bupivacaine, flurbiprofen axetil, and normal saline. Patients in group II are injected with dexamethasone, bupivacaine, flurbiprofen axetil, and normal saline. Patients in group III are administered bupivacaine, flurbiprofen axetil, and normal saline. Pain control and active and passive range of movement are recorded. The following side effects are monitored: headache, dizziness, nausea, vomiting, wound leakage, and wound infection.
What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part but there should be benefits to future patients undergoing TKA because the results of the study are likely to influence which cocktail treatment the surgeon uses. The main risks are the potential complications associated with using opioids and corticosteroids. Therefore, the researchers will set the dosage and compatibility in strict accordance with the drug instructions.
Where is the study run from?
First Affiliated Hospital of Dalian Medical University (China)
When is the study starting and how long is it expected to run for?
January 2018 to May 2021
Who is funding the study?
First Affiliated Hospital of Dalian Medical University (China)
Who is the main contact?
1. Dr Ying Gong, gying202110@163.com
2. Dr Jian Gong, gongjian911@163.com
Contact information
Principal investigator
222 Zhongshan Rd
Xigang District
Dalian
116000
China
| Phone | +86 (0)411 83635963 |
|---|---|
| gying202110@163.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Morphine and dexamethasone incorporated cocktail regimen efficiently reduced postoperative pain in patients undergoing primary total knee arthroplasty |
| Study objectives | The present study was conducted to evaluate the pain-reducing efficacy and safety of the morphine and dexamethasone incorporated cocktail regimen in patients undergoing total knee arthroplasty (TKA). |
| Ethics approval(s) | Approved 01/06/2018, the research ethics committee of the First Affiliated Hospital of Dalian Medical University (222 Zhongshan Rd, Xigang District, Dalian, Dalian, Liaoning, 116000, China; +86 (0)411 8301 0706; dyyyethics@163.com), ref: YJ-JG-2018 |
| Health condition(s) or problem(s) studied | Postoperative pain in patients undergoing primary total knee arthroplasty |
| Intervention | This study enrolled 213 patients and randomly assigned them to one of three groups. The randomisation process was simple randomization. Group I: morphine (5 mg), dexamethasone (5 mg), bupivacaine (10 mg), flurbiprofen axetil (10 mg), and normal saline (20 ml) Group II: dexamethasone (5 mg), bupivacaine (10 mg), flurbiprofen axetil (10 mg), and normal saline (20 ml) Group III: bupivacaine (10 mg), flurbiprofen axetil (10 mg), and normal saline (20 ml) After total knee arthroplasty, the cocktails were injected into the knee cavity once. The total duration of follow-up for all treatment arms was the first 4 days after surgery. To compare the pain-controlling efficiency, the visual analog scale (VAS) score and active and passive range of movement (ROM) were recorded and evaluated. The following side effects were monitored: headache, dizziness, nausea, vomiting, wound leakage, and wound infection. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Morphine, dexamethasone, bupivacaine, flurbiprofen axetil |
| Primary outcome measure(s) |
1. Pain-reducing efficacy measured using the visual analog scale (VAS) score in the first 4 days after TKA surgery |
| Key secondary outcome measure(s) |
1. Complications (wound leakage and superficial infection) and other adverse events (cardiac infarction, stroke, and acute renal failure) monitored using renal function tests including serum creatinine (Cr) and blood urea nitrogen (BUN), physical examination, and questioning the patients during hospitalization |
| Completion date | 01/05/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 250 |
| Total final enrolment | 213 |
| Key inclusion criteria | Patients aged 50–70 years who were scheduled for elective primary total knee arthroplasty (TKA) were assessed for eligibility. This study included all patients who had been diagnosed with knee osteoarthritis |
| Key exclusion criteria | History of knee replacement surgery, hepatic or renal dysfunction, or ischemic heart diseases |
| Date of first enrolment | 04/09/2018 |
| Date of final enrolment | 25/10/2020 |
Locations
Countries of recruitment
- China
Study participating centre
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Ying Gong (gying202110@163.com). The type of data: patient general information, VAS score, active ROM, passive ROM, potential side effects, complications, and other adverse events information. The data provided must be anonymised. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
22/02/2022: Trial's existence confirmed by the research ethics committee of the First Affiliated Hospital of Dalian Medical University.
