Does a combination containing morphine and dexamethasone reduce pain after knee replacement surgery?

ISRCTN	ISRCTN25027558
DOI	https://doi.org/10.1186/ISRCTN25027558
Secondary identifying numbers	CTR20181569

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Ying Gong
Principal Investigator

222 Zhongshan Rd
Xigang District
Dalian
116000
China

Phone	+86 (0)411 83635963
Email	gying202110@163.com

Study information

Study design	Randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a 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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Morphine, dexamethasone, bupivacaine, flurbiprofen axetil
Primary outcome measure	1. Pain-reducing efficacy measured using the visual analog scale (VAS) score in the first 4 days after TKA surgery 2. Active and passive range of movement (ROM) measured using a physical examination of the knee joint in the first 4 days after TKA surgery
Secondary outcome measures	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 2. Potential side effects, including headache, dizziness, nausea, and vomiting, monitored by questioning the patients during hospitalization
Overall study start date	01/01/2018
Completion date	01/05/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

First Affiliated Hospital of Dalian Medical University

116000
China

Sponsor information

First Affiliated Hospital of Dalian Medical University
Hospital/treatment centre

c/o Kang Li
Science and Technology Department
Dalian
116000
China

Phone	+86 (0)411 8611 0149
Email	dyyykjc@163.com
Website	http://www.dmu-1.com/
"ROR"	https://ror.org/055w74b96

Funders

Funder type

Hospital/treatment centre

First Affiliated Hospital of Dalian Medical University

No information available

Results and Publications

Intention to publish date	01/12/2022
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high impact peer-reviewed journal
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.

Editorial Notes

22/02/2022: Trial's existence confirmed by the research ethics committee of the First Affiliated Hospital of Dalian Medical University.