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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001357448
• Date of registration: 29/09/2016
• Prospective Registration: Yes
• Primary sponsor: Dr MD Irfan Gungor
• 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
• Date of first enrolment: 20/10/2016
• Target sample size: 22
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12616001357448.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 4

Countries of recruitment

Turkey

Contacts

• Name: A/Prof Irfan Gungor

• Name: A/Prof Irfan Gungor

Key inclusion & exclusion criteria

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.
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..)



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Anaesthesiology - Other anaesthesiology

Surgery - Other surgery

knee arthroscopy;
knee arthroscopy

Intervention(s)

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 foo

Primary Outcome(s)

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. [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(s)

Surgeon satisfaction with muscle relaxation.
Satisfaction will be assessed using an 11-point scale with 0 = extremely dissatisfied and 10 = extremely satisfied. [Surgeon satisfaction with muscle relaxation will be questioned immediately following the surgery]

Proportion of participants with a reduction in muscle tension, assessed by manual muscle relaxation test following muscle relaxant injection.

[Following 5 and 10 minutes after the end of muscle relaxant/placebo injection.]

Secondary ID(s)

None

Source(s) of Monetary Support

Republic Of Turkey Social Security Institution

Ethics review

Status: Approved
Approval date:
Contact:

Dr. Zekai Tahir Burak Women's Health Research and Education Hospital Clinical Trials Ethics Committee