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Trial registered on ANZCTR


Registration number
ACTRN12616000912482
Ethics application status
Approved
Date submitted
5/06/2016
Date registered
8/07/2016
Date last updated
7/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Postoperative analgesia for elective total knee arthroplasty
Scientific title
Postoperative analgesia for elective total knee arthroplasty under subarachnoid anesthesia with opioids: comparison between epidural, femoral block and adductor canal block techniques.
Secondary ID [1] 289370 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative analgesia for elective total knee arthroplasty 299001 0
Condition category
Condition code
Anaesthesiology 299062 299062 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients scheduled for TKA under spinal anesthesia enrolled during preoperative anesthesia consultation.
Written informed consent obtained from all patients willing to participate in this study.
All patients will receive subarachnoid anesthesia in the sitting position at L3–4 or L4–5 interspace, with a 25-gauge Whitacre needle. We administer 0.5% hyperbaric bupivacaine (Hyperbaric bupivacaine 0.5% 'Registered Trademark', Braun) according to the following formula: bupivacaine (mg) = height (cm) x 0.07, with morphine (Morphine 0.1% 'Registered Trademark',, Braun) 0.15 mg and fentanyl (Fentanest 'Registered Trademark', Kern Pharma) 15 microg. Following injection, patients are immediately kept on lateral decubitus for 6 minutes to improve analgesia.
There are 10 groups:
- control group (without additional blocks).
- epidural analgesia group (the subarachnoid anesthesia in these patients will be performed through the epidural needle at L3-4 or L4-5, the catheter advanced 3-4 cm and levobupivacaine (Chirocane 'Registered Trademark', Abbvie) 0.1% + fentanyl 2 microg.mL-1 (infusion rate 6-10 mL.h-1, bolus volume 5 mL, lock interval 30 min). Epidural infusion is started at the end of surgery.
- femoral nerve block with 20 ml of levobupivacaine 0.375%, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again.
- femoral block with 20 ml of levobupivacaine 0.375% and dexamethasone (Fortecortin 'Registered Trademark', Merck) 4 mg, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again.
- femoral block with 20 ml of levobupivacaine 0.375% and dexmedetomidine (Dexdor 'Registered Trademark', Orionpharma) 100 microg, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again.
- femoral block with 20 ml of levobupivacaine 0.375% and buprenorphine (Buprex 'Registered Trademark', Schering-Plough) 150 microg, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again.
- adductor canal block with 30 ml of levobupivacaine 0.375%, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again.
- adductor canal block with 30 ml of levobupivacaine 0.375% and dexamethasone 4 mg, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again.
- adductor canal block with 30 ml of levobupivacaine 0.375% and dexmedetomidine (Dexdor 'Registered Trademark', Orionpharma) 100 microg, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again.
- adductor canal block with 30 ml of levobupivacaine 0.375% and buprenorphine (Buprex 'Registered Trademark', Schering-Plough) 150 microg, performed 7-10 minutes after spinal anesthesia, when the patient is placed supine again.

Surgeons and anesthesiologists are blinded to the addition of dexamethasone, dexmedetomidine or buprenorphine (perineural medication is prepared by a nurse adding 4 mg of dexamethasone, 100 microg of dexmedetomidine, 150 microg of buprenorphine or 1 ml of saline according to the randomized protocol).

Nerve blocks are single-shots techniques performed under both ultrasound and nerve stimulation (considered adequate at 0.2-0.5 mA) by experienced anesthesiologists.
All patients receive a standardized postoperative IV treatment: metamizole magnesium 8g/24 h, dexketoprofen 50 mg/12h. Postoperative analgesia begins immediately at the end of the surgery, when the patient is admitted to the PACU.
The primary outcome, pain, is measured every hour (respecting the sleep period) during 24 h using a verbal rating 11–point scale for patient self-reporting of pain (VRS-11) previously explained to the patients: from 0 (“no pain”) to 10 (“the most horrible pain you can imagine; such as being burned alive”), and they are also advised to notify their nurse if they feel pain.
Rescue analgesia when needed include:
1st: paracetamol 1 g, maximum 1g/6h/IV
2nd: Morphine 2 mg/15 min, maximum 10 mg/4h/IV
Rescue blocks: femoral, sciatic and epidural
Intervention code [1] 294957 0
Treatment: Other
Intervention code [2] 295075 0
Treatment: Drugs
Comparator / control treatment
The control group receive subarachnoid anesthesia only, without additional blocks
Control group
Active

Outcomes
Primary outcome [1] 298536 0
Pain, assessed. using a verbal rating 11–point scale for patient self-reporting of pain (VRS-11).
Timepoint [1] 298536 0
every hour for 24 hours post surgery completion
The patients are also advised to notify their nurse if they feel pain in every moment
Secondary outcome [1] 325474 0
Hypotension (systolic blood pressure is lower than 75% of basal value) measured with Post-Anesthesia Unit patient's monitors with readings displayed on the monitoring screen.
Timepoint [1] 325474 0
time period admitted in the PACU
Secondary outcome [2] 325475 0
bradycardia (heart rate) less than 60 beats per minute measured with Post-Anesthesia Unit patient's monitors with readings displayed on the monitoring screen.
Timepoint [2] 325475 0
time period admitted in the PACU
Secondary outcome [3] 325476 0
arrhythmias measured with Post-Anesthesia Unit patient's monitors with readings displayed on the monitoring screen.
Timepoint [3] 325476 0
time period admitted in the PACU
Secondary outcome [4] 325477 0
postoperative nausea and vomiting evaluated by means of a 4-point verbal descriptive scale (VDS) (0=no nausea, 1=mild, 2=moderate, 3=severe)
Timepoint [4] 325477 0
time period admitted in the PACU
Secondary outcome [5] 325478 0
vagal syndromes: sudden appearance of bradycardia, dizziness and cold sweats.
Bradycardia (heart rate) less than 60 beats per minute measured with Post-Anesthesia Unit patient's monitors with readings displayed on the monitoring screen, and dizziness and cold sweats by clinical evaluation of the patient in the PACU by the nurse and/or anesthesiologist in charge.
Timepoint [5] 325478 0
time period admitted in the PACU
Secondary outcome [6] 325479 0
sedation measured with Ramsay sedation score
Timepoint [6] 325479 0
time period admitted in the PACU
Secondary outcome [7] 325480 0
restlessness evaluated by means of a 4-point verbal descriptive scale (VDS) (0=no, 1=mild, 2=moderate, 3=severe)
Timepoint [7] 325480 0
time period admitted in the PACU
Secondary outcome [8] 325481 0
bleeding: postoperative losses are calculated based on hematocrit and hemoglobin variations in 3 blood tests (1, 8 and 20 hours after surgery)
Timepoint [8] 325481 0
time period admitted in the PACU

Eligibility
Key inclusion criteria
Patients scheduled for total knee arthroplasty
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unicompartmental knee arthroplasty, refusal to participate, contraindication to spinal or regional anesthesia and/or allergy to the drugs used

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)
Allocation is made by our Statistical Department
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 administering 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
significance level (alpha): 0.05 in a two-sided test
power: 1.000
total sample size: 500 patients
number of groups: 10
effect size: 0.9
Software used: I.B.M. SPSS
Normality of the quantitative parameters: Kolmogorov-Smirnov test.
Comparison of means of independent samples: ANOVA, followed by Dunnett’s test for post hoc testing.
Repeated measures ANOVA is used for paired data.
Association between qualitative variables: chi-square test with Fisher’s exact test where appropriate.
Trends are studied with the chi-square for linear trend test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/08/2016
Actual
21/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 7938 0
Spain
State/province [1] 7938 0
Navarra, Madrid

Funding & Sponsors
Funding source category [1] 293749 0
Hospital
Name [1] 293749 0
Hospital Complex of Navarra
Country [1] 293749 0
Spain
Primary sponsor type
Hospital
Name
Hospital Complex of Navarra
Address
Irunlarrea St, 3,
31008 Pamplona,
Navarra
Country
Spain
Secondary sponsor category [1] 292578 0
Hospital
Name [1] 292578 0
University Hospital Puerta de Hierro Majadahonda
Address [1] 292578 0
Manuel de Falla St,1,
28222 Majadahonda,
Madrid
Country [1] 292578 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295186 0
University Hospital Puerta De Hierro Majadahonda Clinical Research Ethics Committee
Ethics committee address [1] 295186 0
Ethics committee country [1] 295186 0
Spain
Date submitted for ethics approval [1] 295186 0
14/03/2016
Approval date [1] 295186 0
11/04/2016
Ethics approval number [1] 295186 0
Acta number 06.16.

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66438 0
Dr Jose Ramon Ortiz Gomez
Address 66438 0
Service of Anesthesiology.
Hospital Complex of Navarra.
Irunlarrea St, 3,
31008 Pamplona,
Navarra
Country 66438 0
Spain
Phone 66438 0
+34 848 42 22 22
Fax 66438 0
Email 66438 0
jortizgo@cfnavarra.es
Contact person for public queries
Name 66439 0
Jose Ramon Ortiz Gomez
Address 66439 0
Service of Anesthesiology.
Hospital Complex of Navarra.
Irunlarrea St, 3,
31008 Pamplona,
Navarra
Country 66439 0
Spain
Phone 66439 0
+34 848 42 22 22
Fax 66439 0
Email 66439 0
jortizgo@cfnavarra.es
Contact person for scientific queries
Name 66440 0
Jose Ramon Ortiz Gomez
Address 66440 0
Service of Anesthesiology.
Hospital Complex of Navarra.
Irunlarrea St, 3,
31008 Pamplona,
Navarra
Country 66440 0
Spain
Phone 66440 0
+34 848 42 22 22
Fax 66440 0
Email 66440 0
jortizgo@cfnavarra.es

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePostoperative analgesia for elective total knee arthroplasty under subarachnoid anesthesia with opioids: Comparison between epidural, femoral block and adductor canal block techniques (with and without perineural adjuvants). Aprospective, randomized, clinical trial.2017https://dx.doi.org/10.23736/S0375-9393.16.11646-3
EmbaseBuprenorphine versus dexamethasone as perineural adjuvants in femoral and adductor canal nerve blocks for total knee arthroplasty: A randomized, non-inferiority clinical trial.2022https://dx.doi.org/10.23736/S0375-9393.22.16229-2
N.B. These documents automatically identified may not have been verified by the study sponsor.