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Trial registered on ANZCTR


Registration number
ACTRN12616000226404
Ethics application status
Approved
Date submitted
23/01/2016
Date registered
18/02/2016
Date last updated
25/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparision of Intraoperative Epidural Analgesia and Intraoperative Periarticular Injection on Pain Control After Total Knee Arthroplasty
Scientific title
Comparision of Intraoperative Epidural Analgesia (with morphine) and Intraoperative Periarticular Injection (bupivacaine, epinephrine, dexmedetomidine, magnesium sulfate, prednisolone, morphine) on Pain Control After Total Knee Arthroplasty
Secondary ID [1] 288198 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative analgesia after total knee arthroplasty 297108 0
Condition category
Condition code
Anaesthesiology 297344 297344 0 0
Pain management
Surgery 297345 297345 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study interventions were epidural analgesia and periarticular injection. All patients will routinely receive a combined epidural spinal anesthesia. While the patients were in sitting position, appropriate site cleaning was performed and epidural catheter was inserted through the L3-L4 or L4-L5 intervertebral disc spaces using the 18G Tuohy needle. Next, differential spinal block was applied with the 27G Quincke spinal needle through the same disc space. 15mg 0.5% bupivacaine was administered into subarachnoid space. The operation was started when the spinal block reached the suitable level. During the operation, the patients were given oxygen through the Vent mask at a rate of 2 lt /min.
In the Group I (Control group= epidural analgesia group): before wound closure, 3mg morphine sulfate + 7ml saline is administered through epidural catheter in all patients.
In the Group II (periarticular injection group): a 100 ml coctail (0.5% bupivacaine (20 ml), 1 mg/ml of epinephrine (0.6 ml), 100 microgr/ ml of dexmedetomidine (1 ml), 8.4% magnesium sulfate (4ml), 10 mg/ml prednisolone (4 ml), 10 mg/ml morphine (0.5 ml) and 69.9 ml normal saline solution) will be prepared in two 50 ml syringes. This cocktail was administered periarticular injection before wound closure.
The surgical technique and postoperative analgesia protocol were identical in both groups. The patients received patient-controlled epidural analgesia (PCEA) with 110 ml normal saline + 500 microg fentanyl + 200 mg 0.5% bupivacaine for postoperative pain management (bolus dose: 10 ml, lockout period: 20 minutes,without loading dose). All patients received epidural analgesia via the same type of PCA (Patient Controlled Analgesia) device.
The primary outcome is a visual analog scale (VAS) pain score 72 hours after surgery and analgesic consumption. The total amount of analgesics, VAS scores and discharge time was recorded. .In all patients, the epidural catheters were withdrawn at the end of the postoperative 72th hour and 12 hours after the last dose of LMWH (Low Molecular Weight Heparin).
Intervention code [1] 293502 0
Treatment: Drugs
Comparator / control treatment
comparator / control treatment

Group I (epidural analgesia group) is the control group: receiving 3mg morphine sulfate+ 7ml saline is administered epidural before wound closure.

Group II (periarticular injection group ): receiving a 100 ml coctail ( 0.5% bupivacaine (20 ml), 1 mg/ml of epinephrine (0.6 ml), 100 microgr/ ml of dexmedetomidine (1 ml), 8.4% magnesium sulfate (4 ml), 10 mg/ml prednisolone (4 ml), 10 mg/ml morphine (0.5 ml) and 69.9 ml normal saline solution) will be prepared in two 50 ml syringes. This cocktail was administered periarticular injection.
Control group
Active

Outcomes
Primary outcome [1] 296905 0
whether epidural morphine or periarticular multimodal drug injection provides better pain control

The primary outcome is a visual analog scale (VAS) pain score 72 hours after surgery
Timepoint [1] 296905 0
72 hours post surgery
Primary outcome [2] 297363 0
The primary outcome is a analgesic consumption 72 hours after surgery


Datas of analgesic agent consumption are assessed by review of medical records. Analgesic consumption will be calculated by the total amount of analgesic agents spent on Patient-controlled epidural analgesia (PCEA)
Timepoint [2] 297363 0
72 hours post surgery
Secondary outcome [1] 319671 0
adverse events (itching, allergies, nausea, vomiting, urinary retention, constipation, respiratory depression, bradycardia, hypotension, dizziness i.e.)

Adverse events were recorded. If adverse events were recognized, They were evaluated according to Common Terminology Criteria for Adverse Events (CTC-AE) ver. 4.0.

This adverse events listed are assessed as recorded by treating clinician in the medical records

Timepoint [1] 319671 0
72 hours post surgery

Eligibility
Key inclusion criteria
Patients undergoing unilateral total knee arthroplasty as a result of osteoarthritis will be recruited.
Patients will be eligible for inclusion if they are aged greater 18 years, undergoing unilateral total knee arthroplasty as a result of primary osteoarthritis of the knee, can understand and comply with the study protocol,
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- allergy to any drugs used in this study
- previous knee surgery
- bilateral total knee arthroplasty
- severe liver or renal insufficiency
- history of stroke or coronary heart disease
- cognitive impairment
- contraindication for regional anesthesia

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7477 0
Turkey
State/province [1] 7477 0
Bursa

Funding & Sponsors
Funding source category [1] 292593 0
Other
Name [1] 292593 0
Namik Sahin
Address [1] 292593 0
Bursa Yuksek Ihtisas Training and Education Hospital
Orthopaedic Surgery
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa
Country [1] 292593 0
Turkey
Primary sponsor type
Individual
Name
Namik Sahin
Address
Bursa Yuksek Ihtisas Training and Education Hospital
Orthopaedic Surgery
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa
Country
Turkey
Secondary sponsor category [1] 291313 0
Individual
Name [1] 291313 0
Derya Karasu
Address [1] 291313 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa
Turkey
Country [1] 291313 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294077 0
Yuksek Ihtisas Training and Education Hospital Clinical Research Ethics Committee
Ethics committee address [1] 294077 0
Bursa Yuksek Ihtisas Training and Education Hospital
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa
Turkey
Ethics committee country [1] 294077 0
Turkey
Date submitted for ethics approval [1] 294077 0
03/12/2014
Approval date [1] 294077 0
17/12/2014
Ethics approval number [1] 294077 0
2014/23-04

Summary
Brief summary
BACKGROUND: Multimodal analgesia is achieved by the combined use of analgesic agents acting on different parts of the pain pathway. Our aim is to compare effects of epidural analgesia and periarticular injection on the postoperative pain for 48 hours after total knee arthroplasty (TKA) and on the early functional outcomes.
METHODS: Eighty patients with unilateral TKA were included in this study. Patients were treated with epidural morphine in Group E (n = 40) and with periarticular injection (100 ml cocktail solutions: bupivacaine, adrenaline, dexmedetomidine, magnesium sulfate, methylprednisolone, morphine and normal saline) in Group P (n = 40). All patients received postoperative analgesia with an epidural patient-controlled device and useage of bupivacaine + fentanyl was recorded for 48 hours. The maximum range of motion (ROM), visual analog scale (VAS), dynamic visual analog scale (DVAS), and complications were assessed.
RESULTS: 24 and 27 patients were analyzed statistically in Group P and Group E, respectively. Lower VAS and DVAS scores at 48 hours, lower amount of consumed analgesics at 24th and 48th hours, higher ROM values at 2nd and 3rd day and more nausea, vomiting and itching at 12th and 24th hours were observed significantly in Group P.
CONCLUSION: Periarticular injection with multimodal drugs in TKA was found superior to epidural analgesia in our study because of lower VAS-DVAS score, less analgesic consumption, fewer side effects, and more ROM.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62166 0
Dr Derya Karasu
Address 62166 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa
Country 62166 0
Turkey
Phone 62166 0
+905057281175
Fax 62166 0
Email 62166 0
drderyatopuz@gmail.com
Contact person for public queries
Name 62167 0
A/Prof Namik Sahin
Address 62167 0
Bursa Yuksek Ihtisas Training and Education Hospital
Orthopaedic Surgery
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa
Country 62167 0
Turkey
Phone 62167 0
+905057281175
Fax 62167 0
Email 62167 0
drderyatopuz@gmail.com
Contact person for scientific queries
Name 62168 0
Dr Derya Karasu
Address 62168 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/ Bursa
Country 62168 0
Turkey
Phone 62168 0
+905057281175
Fax 62168 0
Email 62168 0
drderyatopuz@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary