The Comparison of the effect of dexmedetomidine and fentanyl as adjuvant to lidocaine on the onset time and duration of ultrasound guided infraclavicular brachial plexus block in orthopedic upper limb surgery

To determine the effectiveness of dexmedetomidine and fentanyl as adjuvant to lidocaine on the onset time and duration and postoperative analgesia of ultrasound guided infraclavicular block in orthopedic upper limb surgery

This is a parallel randomized, double- blinded controlled phase 3 clinical trial of 60 patients. A simple randomization method using a table of random numbers is used to generate a random sequence of patients, and individuals are randomly assigned equally to one of the three study groups (20 patients in each group).

Patients scheduled for elective upper extremity surgery under infraclavicular block in Akhtar Hospital are enrolled in the study and are randomly divided into three equal groups. Participants, investigators, outcome assessors are not aware of the allocation of study groups.

ASA 1 or 2 patients scheduled for unilateral orthopedic surgery of the elbow or forearm or wrist or hand are included in the study if they give informed consent. Exclusion criteria are ASA class≥3, age more than 75 and less than 15 years, allergy to local anesthetics, coagulation disorders, opium addiction, infection at the block site, BMI>30, uncooperative patients, liver or kidney failure, chronic use of painkillers and narcotics, patients who take narcotics before surgery and pregnancy.

The control group receives 19 ml of lidocaine 1.5% + 1 ml of normal saline, fentanyl group receives 19 ml of lidocaine 1.5% + 1 ml containing 50 µg of fentanyl and dexmedetomidine group receives 19 ml of lidocaine 1.5% + 1 ml containing 100 µg of dexmedetomidine for infraclavicular block.

The onset time of sensory and motor block, the time to achieve complete sensory and motor block, duration of sensory and motor block, degree of sedation, hemodynamic parameters, postoperative analgesia

A simple randomization method by a table of random numbers is used to generate a random sequence of patients and participants are randomly assigned to one of the three study groups. To use the table of random numbers, the researcher first determines the direction of reading the numbers in the table. Then numbers 0-20 are considered for the control group, numbers 21-40 for intervention D group, and numbers 41-60 for intervention F group. Then the researcher puts the hand on one of the numbers and moves in the predetermined direction, records the numbers and assigns them to different groups. Each of the randomly assigned sequence numbers are recorded on a card and each card is placed in a sealed numbered envelope with the same card number. When the eligible participants enter the study, the envelopes are selected in order of their sequence and patients receive the intervention of the same group.

Randomization and assignment of patients in each group is done by persons with no involvement in the trial. Participants, investigators, care provider and outcome assessors are unaware of the allocation of individuals in each study group.Since the participants, researchers and outcome assessors are unaware of the allocation of the study groups, and the syringes containing the studied drugs are similar in terms of color and volume, this is a double blinded study.

There is no further information.