Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001357448
Ethics application status
Approved
Date submitted
11/08/2016
Date registered
29/09/2016
Date last updated
29/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of intravenous muscle relaxants for supplying regional muscle relaxation in order to improve relaxation of leg muscles in patients undergoing knee arthroscopy.
Scientific title
Efficacy of regional intravenous muscle relaxant injection for improving relaxation of lower extremity muscles in patients undergoing knee arthroscopy under peripheral nerve blocks
Secondary ID [1] 289876 0
None
Universal Trial Number (UTN)
U1111-1186-1117
Trial acronym
Linked study record
This study is not linked to a parent study

Health condition
Health condition(s) or problem(s) studied:
knee arthroscopy 299820 0
Condition category
Condition code
Anaesthesiology 299744 299744 0 0
Other anaesthesiology
Surgery 299960 299960 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised, double blind, placebo controlled trial to evaluate the degree of muscle relaxation of lower extremity of patients undergoing elective knee arthroscopy under combined sciatic and femoral paravascular nerve blocks. The main target of this study is to objectively prove the benefit of adding an intravascular muscle relaxant drug injection through dorsal feet vessels to improve the insufficiency of muscle relaxation during peripheral nerve block anesthesia.
A total of 22 patients between the ages of 18-65 yr, ASA physical status I and III, scheduled for elective knee arthroscopic surgery under combined sciatic and femoral paravascular nerve blocks will be studied.
Method:
1- Basal values of Motor Evoked Potentials (MEP) will be recorded through adductor magnus, rectus femoris, tibialis anterior and gastrocnemius muscles. MEP’s will be recorded using Magistar 200^2 transmagnetic electric stimulator and Medelec Synergy electroneuromyography instrument. This procedure will be held by the physiatrist who is blind to the study groups.
2- After recording basal MEP values peripheral nerve blocks will be applied. Sciatic nerve block procedure will be followed by femoral paravascular nerve block. By the end of block procedures; MEP’s will be recorded for a 30 minutes period with 5 min intervals. In the same time period pinprick and manuel muscle evaluation tests will be done to evaluate the sensory and motor blocks respectively. This will be held by a consultant anesthetist who is blind to the study groups.
3- After the last evaluations (MEP's, pinprick and manuel muscle tests) at 30 minutes following nerve block application; a the thigh tourniquet will be applied by the surgeon team and a 22G intravascular canula will be inserted on the dorsum of the foot on the side of the knee to be operated by the consultant anesthetist. Afterwards; In Group I, 5 mg of atracurium diluted in 20 mL 0,9% NaCl solution will be injected through the canula. In Group II (control group) only 20 mL 0,9% NaCl solution will be injected. The injections will be done by an anesthetist who takes part in the study.
4- MEP values, pinprick test and manuel muscle test results will be recorded at 5 and 10 minutes following the injections. Determinations will be held by the physiatrist and the consultant anesthetist who are blind to the study groups.
Intervention code [1] 295574 0
Treatment: Drugs
Comparator / control treatment
Control group will receive a placebo (20 mL 0,9% NaCl solution without muscle relaxant) injection.
Control group
Placebo

Outcomes
Primary outcome [1] 299222 0
Proportion of participants with a greater than or equal to 50% reduction in amplitude of MEP values following muscle relaxant injection as compared to measurement at 30th minute after local anesthetic injection during peripheral nerve block.
MEP’s will be recorded using Magistar 200^2 transmagnetic electric stimulator and Medelec Synergy electroneuromyography instrument through adductor magnus, rectus femoris, tibialis anterior and gastrocnemius muscles.
Timepoint [1] 299222 0
Basal MEP values will be recorded prior to peripheral nerve blocks. By the end of block procedures; MEP’s will be recorded for a 30 minutes period with 5 min intervals. The decrease in MEP's through 30 minutes period will be compared to basal values reflecting the effect of local anesthetic solution and the possibly maximum muscle relaxation achieved by the peripheral nerve block.

MEP values will be recorded at 5 and 10 minutes following the muscle relaxant injection and these values will be compared to MEP value recorded at 30 minutes following nerve block reflecting the further muscle relaxation achieved by the muscle relaxant injection
Secondary outcome [1] 326550 0
Proportion of participants with a reduction in muscle tension, assessed by manual muscle relaxation test following muscle relaxant injection.
Timepoint [1] 326550 0
Following 5 and 10 minutes after the end of muscle relaxant/placebo injection.
Secondary outcome [2] 326551 0
Surgeon satisfaction with muscle relaxation.
Satisfaction will be assessed using an 11-point scale with 0 = extremely dissatisfied and 10 = extremely satisfied.
Timepoint [2] 326551 0
Surgeon satisfaction with muscle relaxation will be questioned immediately following the surgery

Eligibility
Key inclusion criteria
Patients (aged of 18-65 yr) with American Society of Anesthesiologists (ASA) physical status I-III, scheduled for elective knee arthroscopy under combined sciatic and femoral paravascular nerve blocks were included in the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal to participate, ASAphysical status IV-V, patients with serious hepatic, renal or cardiovascular disease, neurologic/neuromuscular disease, epilepsy,
peripheral neuropathy, chronic analgesic consumption, unable to cooperate with this research due to cognitive impairment (neuro-psychiatric disease), under medication with anticoagulants, allergy to local anesthetics, pregnancy or breastfeeding, infection at the site of injection and patients with metallic implants (cardiac pacemaker, aneurysm clip etc..)

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)
Allocations were concealed with opaque envelopes, which will only be opened by the assistant who will dispense the local anesthetic solution.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised 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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/10/2016
Actual
Date of last participant enrolment
Anticipated
31/08/2017
Actual
Date of last data collection
Anticipated
31/08/2017
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment outside Australia
Country [1] 8092 0
Turkey
State/province [1] 8092 0
Ankara

Funding & Sponsors
Funding source category [1] 294283 0
Government body
Name [1] 294283 0
Republic Of Turkey Social Security Institution
Country [1] 294283 0
Turkey
Primary sponsor type
Individual
Name
Dr MD Irfan Gungor
Address
Gazi University Faculty of Medicine
Dep of Anaesthesiology and Reanimation
Boulevard of Mevlana
Besevler/ANKARA
(Postal Code: 06500)
Country
Turkey
Secondary sponsor category [1] 293117 0
None
Name [1] 293117 0
Address [1] 293117 0
Country [1] 293117 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295715 0
Dr. Zekai Tahir Burak Women's Health Research and Education Hospital Clinical Trials Ethics Committee
Ethics committee address [1] 295715 0
Zekai Tahir Burak Kadin Sagligi Egitim Ve Arastirma Hastanesi
Talatpasa Street
Samanpazari / ANKARA
Postal Code: 06230
Ethics committee country [1] 295715 0
Turkey
Date submitted for ethics approval [1] 295715 0
25/06/2010
Approval date [1] 295715 0
19/01/2016
Ethics approval number [1] 295715 0
Karar No: 1/2016

Summary
Brief summary
Knee arthroscopy can be applied under either general anesthesia, spinal/epidural anesthesia or peripheral nerve blocks (PNB). Muscle relaxation may be insufficient in PNB when compared to general anesthesia. The aim of this study is to improve the lack of muscle relaxation by intravenous injection of a muscle relaxant (atracurium). The injected solution will be restricted in the area between the injection point on the foot and the tourniquet applied on the thigh. The tourniquet will prevent the drug to leak into the circulation like mentioned in the technique described in Bier's block or regional intravenous anesthesia (RIVA).
The main hypothesis is that the possible insufficiency of muscle relaxation by local anesthetics in PNB's may be improved using a muscle relaxant in a restricted area from the main vascular circulation.
The primary outcome of improvement in muscle relaxation will be monitored with the decrease in MEP's.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1016 1016 0 0
/AnzctrAttachments/371255-Ethics approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 68078 0
A/Prof Irfan Gungor
Address 68078 0
Gazi University Faculty of Medicine Dep of Anaesthesiolgy and Reanimation
Besevler/ANKARA
Postal Code: 06560
Country 68078 0
Turkey
Phone 68078 0
+905057757490
Fax 68078 0
Email 68078 0
[email protected]
Contact person for public queries
Name 68079 0
A/Prof Irfan Gungor
Address 68079 0
Gazi University Faculty of Medicine Dep of Anaesthesiolgy and Reanimation
Besevler/ANKARA
Postal Code: 06560
Country 68079 0
Turkey
Phone 68079 0
+905057757490
Fax 68079 0
Email 68079 0
[email protected]
Contact person for scientific queries
Name 68080 0
A/Prof Irfan Gungor
Address 68080 0
Gazi University Faculty of Medicine Dep of Anaesthesiolgy and Reanimation
Besevler/ANKARA
Postal Code: 06560
Country 68080 0
Turkey
Phone 68080 0
+905057757490
Fax 68080 0
Email 68080 0
[email protected]

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