Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-11

Study Completion Date

2024-11-01

Brief Summary

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Combined femoral and sciatic nerve block provides surgical anesthesia with better cardiorespiratory stability as compared to the spinal anesthesia blockade which has side effects of hypotension, bradycardia, meningitis, post dural puncture headache, hematoma, and neurological deficit

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Detailed Description

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Combined femoral and sciatic nerve block provides surgical anesthesia with better cardiorespiratory stability as compared to the spinal anesthesia blockade which has side effects of hypotension, bradycardia, meningitis, post dural puncture headache, hematoma, and neurological deficit, Adjuvants are those drugs which, when co-administered with local anesthetic agents, may improve the speed of onset and duration of analgesia and counteract disadvantageous effects of local anesthetics. By adding these adjuvants, the dose of local anesthetics like bupivacaine can be reduced, thereby reducing its side effects like myocardial depression, hypotension, bradycardia, heart block, and ventricular arrhythmias. Based on "Combination Wisdom", the use of adjuvants to local anesthetics has been promoted a lot .A wide variety of drugs have been used for both neuraxial and peripheral nerve blocks, and the most commonly used drug as adjuvant is the fentanyl .

The addition of dexmedetomidine during US-guided combined femoral and sciatic block for below knee surgery was associated with a prolonged duration of analgesia.

Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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group (dexmedetomidine group )

the sciatic and femoral nerve blocks will be achieved using A 40 ml mixture consisting of 0.25% bupivacaine and 1 µ/kg dexmedetomidine.

Group Type ACTIVE_COMPARATOR

dexmedetomidine as adjuvant to bupivacaine

Intervention Type DRUG

the efficacy of addition of dexmedetomidine as adjuvants to bupivacaine in femorosciatic nerve block

group (fentanyl group )

the sciatic and femoral nerve blocks will be achieved using A 40 ml mixture consisting of 0.25% bupivacaine with 1 µg/kg of fentanyl.

Group Type ACTIVE_COMPARATOR

Fentanyl as adjuvant to bupivacaine

Intervention Type DRUG

the efficacy of addition of fentanyl as adjuvants to bupivacaine in femorosciatic nerve block

Interventions

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dexmedetomidine as adjuvant to bupivacaine

the efficacy of addition of dexmedetomidine as adjuvants to bupivacaine in femorosciatic nerve block

Intervention Type DRUG

Fentanyl as adjuvant to bupivacaine

the efficacy of addition of fentanyl as adjuvants to bupivacaine in femorosciatic nerve block

Intervention Type DRUG

Other Intervention Names

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adjuvants to local anesthetics adjuvants to local anesthetics

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18-65 years.
* American Society of Anesthesiologists (ASA) physical status I-II,
* Scheduled for elective surgery below the knee.

Exclusion Criteria

* Allergies to used medications.
* Coagulopathy.
* Septic patients.
* Neurological disease.
* Respiratory or cardiac disease.
* Diabetes mellitus.
* Patients' refusal to participate.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No