Not Yet RecruitingPhase 4ACTRN12616001357448

Efficacy of intravenous muscle relaxants for supplying regional muscle relaxation in order to improve relaxation of leg muscles in patients undergoing knee arthroscopy.

Efficacy of regional intravenous muscle relaxant injection for improving relaxation of lower extremity muscles in patients undergoing knee arthroscopy under peripheral nerve blocks


Sponsor

Dr MD Irfan Gungor

Enrollment

22 participants

Start Date

Oct 20, 2016

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria1

  • 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.

Exclusion Criteria2

  • 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..)

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Interventions

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 pa

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.


Locations(1)

Ankara, Turkey

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ACTRN12616001357448


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