Analgesia, PostoperativeNCT06759116
Comparison Between Fentanyl and Dexmedetomidine As Adjuvant to Bupivacaine in Combined IPACK and Adductor Canal Block for Postoperative Analgesia After Knee Surgeries
A study testing Fentanyl group and Dexmedetomidine group in people with Analgesia, Postoperative, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Postoperative
- What is being tested?
- Fentanyl group and Dexmedetomidine group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2025to 10 Aug 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- . 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)
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
faculty of human medicine, Zagazig university hospitals
El Sharkia
SHERIF MOWAFY, MD, 01003523374 ext. 002, SHERIFMOWAFY2012@GMAIL.COM
Sherine Abd Ellatif, MD, 01007948840 ext. 002
About this study
Official title: Analgesic Effect of Fentanyl Vs Dexmedetomidine As Adjuvant to Bupivacaine in Combined IPACK and Adductor Canal Block After Knee Surgeries
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.
Read the 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).
- Conditions
- Analgesia, Postoperative
- Being tested
- Control group, Fentanyl group, Dexmedetomidine group
- Keywords
- fentanyl, dexamedetomidine, analgesia, IPACK and adductor canal block, knee surgeries
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupProcedure or surgery
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 groupProcedure or surgery
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 groupProcedure or surgery
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). )
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: Control group |
| 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) Receives: Procedure: Fentanyl group |
| 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). ) Receives: Procedure: Dexmedetomidine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
● The total amount of rescue analgesic consumption (tramadol)
● The total amount of rescue analgesic consumption (tramadol) postoperatively in each group
Measured: 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)
Measured: 0 hours (basal) ( on arrival to PACU), 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs and 48 hrs
Secondary outcomes (4)
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)
Measured: 24 hours postoperative
The length of hospital stays
The length of hospital stays (number of hospital stay days starting from discharge from PACU till discharge home).
Measured: For 48-72 hrs
The incidence of adverse events
The incidence of adverse events (hematoma, local anesthetic toxicity, infection, nausea and vomiting).
Measured: 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)
Measured: For 48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start10 Jan 2025
- Primary completion10 Jul 2025 (estimated)
- Study completion10 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Analgesic Effect of Fentanyl versus Dexmedetomidine as Adjuvants to Bupivacaine in combined IPACK and Adductor Canal Block after Knee Surgeries
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dina Abdelhameed Elsadek Salem, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759116
- Sponsor's protocol ID
- 940
- Status last verified
- Dec 2024
- First submitted
- 29 Dec 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No