Analgesia, Postoperative
Conditions
Keywords
fentanyl, dexamedetomidine, analgesia, IPACK and adductor canal block, knee surgeries
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).
Interventions
PROCEDUREControl group
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)
PROCEDUREFentanyl group
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)
PROCEDUREDexmedetomidine group
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). )
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
anesthetist not sharing in the study will assess patients
Intervention model description
Analgesic Effect of Fentanyl versus Dexmedetomidine as Adjuvants to Bupivacaine in combined IPACK and Adductor Canal Block after Knee Surgeries
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
Yes
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) \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ● 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Egypt
Contacts
Primary ContactDina Sadek Salem, MD
Backup ContactSherif Mowafy, MD
Outcome results
None listed