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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Fentanyl Vs Dexmedetomidine As Adjuvant to Bupivacaine in Combined IPACK and Adductor Canal Block After Knee Surgeries
- ClinicalTrials.gov ID
- NCT06759116
- Acronym / sponsor ID
- 940
- Conditions
- Analgesia, Postoperative
- Keywords
- fentanyl, dexamedetomidine, analgesia, IPACK and adductor canal block, knee surgeries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 10 Jul 2025 (estimated)
- Study completion
- 10 Aug 2025 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Analgesic Effect of Fentanyl versus Dexmedetomidine as Adjuvants to Bupivacaine in combined IPACK and Adductor Canal Block after Knee Surgeries
| Arm | Type | Receives |
|---|---|---|
| Control group (group C) | Active comparator | Procedure: Control groupThe 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 | Procedure: Fentanyl groupThe 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 | Procedure: Dexmedetomidine groupThe 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). ) |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (4 listed)
- . 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)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control groupThe 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) | Procedure or surgery | Control group (group C) |
| Fentanyl groupThe 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) | Procedure or surgery | Fentanyl group (group F) |
| Dexmedetomidine groupThe 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). ) | Procedure or surgery | Dexmedetomidine group (group D) |
Primary outcome
● The total amount of rescue analgesic consumption (tramadol)
Time frame: 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
Time frame: 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)
4 secondary outcomes
The time to first request of rescue analgesia (tramadol)
Time frame: 24 hours postoperative
The length of hospital stays
Time frame: For 48-72 hrs
The incidence of adverse events
Time frame: For 48 hrs
patient's satisfaction
Time frame: For 48 hrs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl group and Dexmedetomidine group in people with Analgesia, Postoperative, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dina Sadek Salem, MD (01099333513 ext. 002, sherifelagamy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
● The total amount of rescue analgesic consumption (tramadol) (time frame: For 48 hrs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.