Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine

NCT06864416 | Completed Phase 4

• 1 other identifier: FMASU MS199/2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Visual analogue score assessment

  Score range from zero to ten , lower score indicate accepted out come

  6 hours from performing the block

Secondary Outcomes (1)

• The time of first analgesics required

  Immediately after the end of the surgery and for 48 hours

Study Arms (2)

group (dexmedetomidine group )

ACTIVE COMPARATOR

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

Drug: dexmedetomidine as adjuvant to bupivacaine

group (fentanyl group )

ACTIVE COMPARATOR

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.

Drug: Fentanyl as adjuvant to bupivacaine

Interventions

dexmedetomidine as adjuvant to bupivacaine DRUG

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

Also known as: adjuvants to local anesthetics

group (dexmedetomidine group )

Fentanyl as adjuvant to bupivacaine DRUG

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

Also known as: adjuvants to local anesthetics

group (fentanyl group )

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University, abbasia

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine; Fentanyl

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: March 7, 2025
• Study Start: March 11, 2024
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-01

Locations

EG (1)