Clinical trial NCT06759116: Comparison Between Fentanyl and Dexmedetomidine As Adjuvant to Bupivacaine in Combined IPACK and Adductor Canal Block for Postoperative Analgesia After Knee Surgeries
Official title: Analgesic Effect of Fentanyl Vs Dexmedetomidine As Adjuvant to Bupivacaine in Combined IPACK and Adductor Canal Block After Knee Surgeries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia, Postoperative
Keywords: fentanyl
dexamedetomidine
analgesia
IPACK and adductor canal block
knee surgeries
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2025-01-06
Enrollment: 111
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Analgesic Effect of Fentanyl versus Dexmedetomidine as Adjuvants to Bupivacaine in combined IPACK and Adductor Canal Block after Knee Surgeries
Primary purpose: TREATMENT

Brief summary: This study will be undertaken to compare the analgesic effects of of fentanyl versus dexmedetomidine as adjuvant to bupivacaine in combined IPACK and ACB for pain management after total knee arthroplasty.

Detailed description: * To measure the total amount of rescue analgesic consumption in the first 48 hours post-operatively in each group
* To assess pain score in each group by using Numerical Rating Scale (NRS) at rest (static) and during flexion or extension of knee (dynamic) at different time points: PACU, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs and 48 hrs.
* To measure the time of first request of rescue analgesia in each group
* To record the incidence of adverse events (hematoma, local anesthetic toxicity, infection, nausea and vomiting) and length of hospital stay.
* Over all patients' satisfaction: The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points Likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia).

Eligibility criteria: Inclusion Criteria:

1 - Patient acceptance 2. Cooperative patients 3. Age: ≥21 and 85\< years' old 4. Sex: both sexes (males or females). 5. Physical status: ASA Ι \& II\& Ш. 6. Body Mass Index (BMI): ≤ 35 kg/m2. 7. Type of operation: elective unilateral knee surgeries (TKA, ACL, knee arthroscopy)

Exclusion Criteria:

. Patient with any contraindications of regional blocks (as coagulopathy or local infection at injection site) 2. Patients with known history of allergy to the study drugs (bupivacaine, dexmedetomidine and fentanyl).

3. Advanced hepatic, renal, cardiovascular, neurologic and respiratory diseases.

4.Chronic opioid use (more than 3 months or daily oral morphine \> 5 mg /day for 1 month)

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Primary outcomes:
measure: ● The total amount of rescue analgesic consumption (tramadol)
timeFrame: For 48 hrs
measure: Pain intensity by using Numerical Rating Scale (NRS) at rest (static) and during flexion or extension of knee (dynamic) at different time points
timeFrame: 0 hours (basal) ( on arrival to PACU), 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs and 48 hrs
Secondary outcomes:
measure: The time to first request of rescue analgesia (tramadol)
timeFrame: 24 hours postoperative
measure: The length of hospital stays
timeFrame: For 48-72 hrs
measure: The incidence of adverse events
timeFrame: For 48 hrs
measure: patient's satisfaction
timeFrame: For 48 hrs
Other outcomes:
Locations:
city: El sharkia
country: Egypt
facility: faculty of human medicine, Zagazig university hospitals
Study officials:
References: