Post Operative PainPhase 4NCT06864416
Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine
A Phase 4 study testing dexmedetomidine as adjuvant to bupivacaine and Fentanyl as adjuvant to bupivacaine in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
Combined femoral and sciatic nerve block provides surgical anesthesia with better cardiorespiratory stability as compared to the spinal anesthesia blockade which has side effects of hypotension, bradycardia, meningitis, post dural puncture headache, hematoma, and neurological deficit Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- dexmedetomidine as adjuvant to bupivacaine and Fentanyl as adjuvant to bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Mar 2024to 1 Nov 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 years.
- American Society of Anesthesiologists (ASA) physical status I-II,
- Scheduled for elective surgery below the knee.
Who cannot join
- Allergies to used medications.
- Coagulopathy.
- Septic patients.
- Neurological disease.
- Respiratory or cardiac disease.
- Diabetes mellitus.
- Patients' refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine in Femero Sciatic Block for Below Knee Surgery
Combined femoral and sciatic nerve block provides surgical anesthesia with better cardiorespiratory stability as compared to the spinal anesthesia blockade which has side effects of hypotension, bradycardia, meningitis, post dural puncture headache, hematoma, and neurological deficit
Read the detailed description
Combined femoral and sciatic nerve block provides surgical anesthesia with better cardiorespiratory stability as compared to the spinal anesthesia blockade which has side effects of hypotension, bradycardia, meningitis, post dural puncture headache, hematoma, and neurological deficit, Adjuvants are those drugs which, when co-administered with local anesthetic agents, may improve the speed of onset and duration of analgesia and counteract disadvantageous effects of local anesthetics. By adding these adjuvants, the dose of local anesthetics like bupivacaine can be reduced, thereby reducing its side effects like myocardial depression, hypotension, bradycardia, heart block, and ventricular arrhythmias. Based on "Combination Wisdom", the use of adjuvants to local anesthetics has been promoted a lot .A wide variety of drugs have been used for both neuraxial and peripheral nerve blocks, and the most commonly used drug as adjuvant is the fentanyl .
The addition of dexmedetomidine during US-guided combined femoral and sciatic block for below knee surgery was associated with a prolonged duration of analgesia.
- Conditions
- Post Operative Pain
- Being tested
- dexmedetomidine as adjuvant to bupivacaine, Fentanyl as adjuvant to bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine as adjuvant to bupivacaineDrug
Also called adjuvants to local anesthetics
the efficacy of addition of dexmedetomidine as adjuvants to bupivacaine in femorosciatic nerve block
Fentanyl as adjuvant to bupivacaineDrug
Also called adjuvants to local anesthetics
the efficacy of addition of fentanyl as adjuvants to bupivacaine in femorosciatic nerve block
| Study group | Role | What they receive |
|---|---|---|
| group (dexmedetomidine group ) | Active comparator | the sciatic and femoral nerve blocks will be achieved using A 40 ml mixture consisting of 0.25% bupivacaine and 1 µ/kg dexmedetomidine. Receives: Drug: dexmedetomidine as adjuvant to bupivacaine |
| group (fentanyl group ) | Active comparator | the sciatic and femoral nerve blocks will be achieved using A 40 ml mixture consisting of 0.25% bupivacaine with 1 µg/kg of fentanyl. Receives: Drug: Fentanyl as adjuvant to bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue score assessment
Score range from zero to ten , lower score indicate accepted out come
Measured: 6 hours from performing the block
Secondary outcomes (1)
The time of first analgesics required
analgesics requirements
Measured: Immediately after the end of the surgery and for 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start11 Mar 2024
- Primary completion1 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864416
- Sponsor's protocol ID
- FMASU MS199/2024
- Status last verified
- Jan 2025
- First submitted
- 14 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine in Femero Sciatic Block for Below Knee Surgery
- ClinicalTrials.gov ID
- NCT06864416
- Acronym / sponsor ID
- FMASU MS199/2024
- Conditions
- Post Operative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 7 Mar 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.
Combined femoral and sciatic nerve block provides surgical anesthesia with better cardiorespiratory stability as compared to the spinal anesthesia blockade which has side effects of hypotension, bradycardia, meningitis, post dural puncture headache, hematoma, and neurological deficit
Detailed description
Combined femoral and sciatic nerve block provides surgical anesthesia with better cardiorespiratory stability as compared to the spinal anesthesia blockade which has side effects of hypotension, bradycardia, meningitis, post dural puncture headache, hematoma, and neurological deficit, Adjuvants are those drugs which, when co-administered with local anesthetic agents, may improve the speed of onset and duration of analgesia and counteract disadvantageous effects of local anesthetics. By adding these adjuvants, the dose of local anesthetics like bupivacaine can be reduced, thereby reducing its side effects like myocardial depression, hypotension, bradycardia, heart block, and ventricular arrhythmias. Based on "Combination Wisdom", the use of adjuvants to local anesthetics has been promoted a lot .A wide variety of drugs have been used for both neuraxial and peripheral nerve blocks, and the most commonly used drug as adjuvant is the fentanyl .
The addition of dexmedetomidine during US-guided combined femoral and sciatic block for below knee surgery was associated with a prolonged duration of analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group (dexmedetomidine group ) | Active comparator | Drug: dexmedetomidine as adjuvant to bupivacainethe sciatic and femoral nerve blocks will be achieved using A 40 ml mixture consisting of 0.25% bupivacaine and 1 µ/kg dexmedetomidine. |
| group (fentanyl group ) | Active comparator | Drug: Fentanyl as adjuvant to bupivacainethe sciatic and femoral nerve blocks will be achieved using A 40 ml mixture consisting of 0.25% bupivacaine with 1 µg/kg of fentanyl. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-65 years.
- American Society of Anesthesiologists (ASA) physical status I-II,
- Scheduled for elective surgery below the knee.
Key exclusion criteria (7 listed)
- Allergies to used medications.
- Coagulopathy.
- Septic patients.
- Neurological disease.
- Respiratory or cardiac disease.
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 |
|---|---|---|
| dexmedetomidine as adjuvant to bupivacaineAlso: adjuvants to local anestheticsthe efficacy of addition of dexmedetomidine as adjuvants to bupivacaine in femorosciatic nerve block | Drug | group (dexmedetomidine group ) |
| Fentanyl as adjuvant to bupivacaineAlso: adjuvants to local anestheticsthe efficacy of addition of fentanyl as adjuvants to bupivacaine in femorosciatic nerve block | Drug | group (fentanyl group ) |
Primary outcome
Visual analogue score assessment
Time frame: 6 hours from performing the block
Score range from zero to ten , lower score indicate accepted out come
1 secondary outcome
The time of first analgesics required
Time frame: Immediately after the end of the surgery and for 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexmedetomidine as adjuvant to bupivacaine and Fentanyl as adjuvant to bupivacaine in people with Post Operative Pain, run by Ain Shams 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 7 Mar 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue score assessment (time frame: 6 hours from performing the block). 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 7 Mar 2025.