Comparison Between Fentanyl and Dexmedetomidine As Adjuvant to Bupivacaine in Combined IPACK and Adductor Canal Block for Postoperative Analgesia After Knee Surgeries

Not Applicable

Recruiting

• Conditions: Analgesia, Postoperative

• Registration Number: NCT06759116
• Lead Sponsor: Zagazig University

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).

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-29
• Study First Submitted QC: 2024-12-29
• Study First Posted: 2025-01-06
• Study Start: 2025-01-10
• Last Update Submitted: 2025-01-12
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-07-10
• Study Completion: 2025-08-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 111

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
● The total amount of rescue analgesic consumption (tramadol)	For 48 hrs	● The total amount of rescue analgesic consumption (tramadol) postoperatively in each group
Pain intensity by using Numerical Rating Scale (NRS) at rest (static) and during flexion or extension of knee (dynamic) at different time points	0 hours (basal) ( on arrival to PACU), 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs and 48 hrs	NRS is 10 cm line numbered from 0 to 10, patients instructed to circle the number that represents his/her pain intensity (0=no pain and 10=maximum pain)

Secondary Outcome Measures

Name	Time	Method
The time to first request of rescue analgesia (tramadol)	24 hours postoperative	The time to first request of rescue analgesia (tramadol) (time from end of local anesthetics injection till time of NRS ≥ 3)
The length of hospital stays	For 48-72 hrs	The length of hospital stays (number of hospital stay days starting from discharge from PACU till discharge home).
The incidence of adverse events	For 48 hrs	The incidence of adverse events (hematoma, local anesthetic toxicity, infection, nausea and vomiting).
patient's satisfaction	For 48 hrs	patient's 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)

Trial Locations

Locations (1)

faculty of human medicine, Zagazig university hospitals; 🇪🇬 El sharkia, Egypt