The effect of adding dexmedetomidine and fentanyl to lidocaine on the the quality of infraclavicular peripheral block in upper extremity orthopedic surgery

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20131108015322N7

Enrollment

Registered

2022-10-08

Start date

2022-10-07

Completion date

Unknown

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improving the quality of infraclavicular brachial plexus block in terms of the onset and length of sensory and motor block and analgesic effect.

Interventions

Intervention 1: Control group: Receives 19 ml of lidocaine 1.5% with epinephrine 1:200000 + 1 ml of normal saline for infraclavicular block. Intervention 2: Fentanyl group: Receives 19 ml of lidocaine

Eligibility

Sex/Gender

All

Age

15 Years to 75 Years

Inclusion criteria

Inclusion criteria: ASA class1 and 2 unilateral upper limb surgery age 15-75 years patient's acceptance

Exclusion criteria

Exclusion criteria: ASA class=3 Allergy to local anesthetics Age more than 75 yrs and less than 15 yrs Coagulation disorders Opium addiction Infection at the block site BMI >30 liver or kidney failure chronic use of painkillers and narcotics patients who take narcotics before surgery pregnancy

Design outcomes

Primary

Measure	Time frame
The onset time of sensory block. Timepoint: After the end of local anesthetic injection every 5 minutes for 20 minutes. Method of measurement: Based on a 0-2 grading scale.;The onset time of motor block. Timepoint: After the end of local anesthetic injection every 5 minutes for 20 minutes. Method of measurement: Based on modified Bromage scale 0-3.;Duration of sensory block. Timepoint: After the end of local anesthetic injection every 5 minutes for 20 minutes. Method of measurement: Based on a 0-2 grading scale.;Duration of motor block. Timepoint: After the end of local anesthetic injection every 5 minutes for 20 minutes. Method of measurement: Based on modified Bromage scale 0-3.	—

Measure

Time frame

The onset time of sensory block. Timepoint: After the end of local anesthetic injection every 5 minutes for 20 minutes. Method of measurement: Based on a 0-2 grading scale.;The onset time of motor block. Timepoint: After the end of local anesthetic injection every 5 minutes for 20 minutes. Method of measurement: Based on modified Bromage scale 0-3.;Duration of sensory block. Timepoint: After the end of local anesthetic injection every 5 minutes for 20 minutes. Method of measurement: Based on a 0-2 grading scale.;Duration of motor block. Timepoint: After the end of local anesthetic injection every 5 minutes for 20 minutes. Method of measurement: Based on modified Bromage scale 0-3.

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Secondary

Measure	Time frame
Heart rate. Timepoint: Before the block, 10, 20, and 30 minutes after the block, 5, 10, and 15 minutes after entering the recovery room, and 3, 12, and 24 hours after operation. Method of measurement: Electrocardiogram, Pulse oximeter.;Systolic blood pressure. Timepoint: Before the block, 10, 20, and 30 minutes after the block, 5, 10, and 15 minutes after entering the recovery room, and 3, 12, and 24 hours after operation. Method of measurement: Noninvasive Blood pressure measurement method.;Sedation level. Timepoint: Before the block, 10, 20, and 30 minutes after the block, 5, 10, and 15 minutes after entering the recovery room, and 3, 12, and 24 hours after operation. Method of measurement: Sedation scale with a rating of 1-4.;Pain severity. Timepoint: 10, 20 and 30 minutes after the start of the operation, 5, 10 and 15 minutes after entering the recovery and 3, 12 and 24 hours after operation. Method of measurement: A 5-point verbal rating scale (VRS) consisting of (0 =no pain, 4=unbearable pain).;Total number of patient’s requests for systemic analgesics. Timepoint: In the first 24 hours after operation. Method of measurement: Recording the number of requests for analgesic.	—

Measure

Time frame

Heart rate. Timepoint: Before the block, 10, 20, and 30 minutes after the block, 5, 10, and 15 minutes after entering the recovery room, and 3, 12, and 24 hours after operation. Method of measurement: Electrocardiogram, Pulse oximeter.;Systolic blood pressure. Timepoint: Before the block, 10, 20, and 30 minutes after the block, 5, 10, and 15 minutes after entering the recovery room, and 3, 12, and 24 hours after operation. Method of measurement: Noninvasive Blood pressure measurement method.;Sedation level. Timepoint: Before the block, 10, 20, and 30 minutes after the block, 5, 10, and 15 minutes after entering the recovery room, and 3, 12, and 24 hours after operation. Method of measurement: Sedation scale with a rating of 1-4.;Pain severity. Timepoint: 10, 20 and 30 minutes after the start of the operation, 5, 10 and 15 minutes after entering the recovery and 3, 12 and 24 hours after operation. Method of measurement: A 5-point verbal rating scale (VRS) consisting of (0 =no pain, 4=unbearable pain).;Total number of patient’s requests for systemic analgesics. Timepoint: In the first 24 hours after operation. Method of measurement: Recording the number of requests for analgesic.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShideh Dabir

Shahid Beheshti University of Medical Sciences

shdabir@yahoo.com+98 21 2243 2595

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026