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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group (group C) | Active Comparator | The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 1 ml saline) |
|
| Fentanyl group (group F) | Active Comparator | The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 50 mcg fentanyl) |
|
| Dexmedetomidine group (group D) | Active Comparator | The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 1 ug/kg dexmedetomidine not exceeding 100 ug (to be completed to 1mL with normal saline if needed). ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control group | Procedure | The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 1 ml saline) |
| Measure | Description | Time Frame |
|---|---|---|
| ● The total amount of rescue analgesic consumption (tramadol) | ● The total amount of rescue analgesic consumption (tramadol) postoperatively in each group | For 48 hrs |
| Pain intensity by using Numerical Rating Scale (NRS) at rest (static) and during flexion or extension of knee (dynamic) at different time points | 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) | 0 hours (basal) ( on arrival to PACU), 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs and 48 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| The time to first request of rescue analgesia (tramadol) | The time to first request of rescue analgesia (tramadol) (time from end of local anesthetics injection till time of NRS ≥ 3) | 24 hours postoperative |
| The length of hospital stays |
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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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dina Sadek Salem, MD | Contact | 01099333513 | 002 | sherifelagamy@yahoo.com |
| Sherif Mowafy, MD | Contact | 01003523374 | 002 | sherifmowafy2012@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of human medicine, Zagazig university hospitals | Recruiting | El Sharkia | Egypt |
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Analgesic Effect of Fentanyl versus Dexmedetomidine as Adjuvants to Bupivacaine in combined IPACK and Adductor Canal Block after Knee Surgeries
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anesthetist not sharing in the study will assess patients
| Fentanyl group | Procedure | The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 50 mcg fentanyl) |
|
| Dexmedetomidine group | Procedure | The patient receive unilateral ultrasound guided combined IPACK and ACB with bupivacaine only. two syringes , one for each block , each one contains (20 mL of 0.25% bupivacaine and 1 ug/kg dexmedetomidine not exceeding 100 ug (to be completed to 1mL with normal saline if needed). ) |
|
The length of hospital stays (number of hospital stay days starting from discharge from PACU till discharge home).
| For 48-72 hrs |
| The incidence of adverse events | The incidence of adverse events (hematoma, local anesthetic toxicity, infection, nausea and vomiting). | For 48 hrs |
| patient's satisfaction | 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) | For 48 hrs |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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