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AzTrials

AnalgesiaNCT04442906

Analgesia After Knee Arthroscopy :Dexmedetomidine vs Fentanyl

A study testing Dexmedetomidine, Fentanyl and Bupivacain in people with Analgesia, run by Zagazig University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to evaluate analgesic effects Bupivacaine, Bupivacaine plus Dexmedetomidine and Bupivacaine plus Fentanyl in relieving pain after knee arthroscopic surgery. Read more about this study

Who is it for?
Ages 21 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Analgesia
What is being tested?
Dexmedetomidine, Fentanyl and Bupivacain
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteEgypt
Study dates
1 Jul 2020to 1 Dec 2020
Phase
Interventional
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 21 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Either sex,
  • Age 21-45 years,
  • American Society of Anesthesia (ASA) I - II for elective knee arthroscopy.

Who cannot join

  • The patients with history of hepatic and renal diseases, psychiatric disorders,
  • Prolonged intake of (NSAIDS, opioids and tricyclic antidepressant),
  • Allergy to study drugs and patient who received analgesics up to 24 hr. before surgery were excluded from this study.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Zagazig university

    Zagazig

Other trials in Egypt

About this study

Official title: Comparative Study Between Dexmedetomidine and Fentanyl as an Adjuvant to Intra-articular Bupivacaine for Postoperative Analgesia After Knee Arthroscopy.

The aim of this study is to evaluate analgesic effects Bupivacaine, Bupivacaine plus Dexmedetomidine and Bupivacaine plus Fentanyl in relieving pain after knee arthroscopic surgery.

Read the detailed description

Forty-five patients ASA I - II aged 21-45 years for elective knee arthroscopy were divided into 3 groups: Group B, BD and BF. Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline. Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).

Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug). The time of first request of analgesia and analgesic effect by VAS during the first 24 hr. postoperatively are recorded.

Conditions
Analgesia
Being tested
Dexmedetomidine, Fentanyl, Bupivacain
Keywords
dexmedetomidine, fentanyl, bupivacaine, knee arthroscopy, postoperative analgesia
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Also called precedex

    Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).

  • FentanylDrug

    Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug)

  • BupivacainDrug

    Also called marcaine

    Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline.

Study groups in NCT04442906
Study groupRoleWhat they receive
group BActive comparatorIGroup B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline
Receives: Drug: Bupivacain
group BDActive comparator. Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).
Receives: Drug: Dexmedetomidine; Drug: Bupivacain
group BFActive comparatorGroup BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug).
Receives: Drug: Fentanyl; Drug: Bupivacain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of postoperative analgesia

    start from intra-articular injection of the drug to the time of first request of analgesia

    Measured: For 24 hours postoperative

Secondary outcomes (23)

  1. total dose of rescue analgesia ( pethidine)

    total consumption of rescue analgesia (pethidine) postoperative

    Measured: within 24 hours postoperative

  2. The number of participants with bradycardia, itching and hypotension

    The number of participants with bradycardia less than 50 beat per minute, itching and hypotension if mean arterial blood pressure less than 20% of basal )

    Measured: Within 24 hours postoperative

  3. patient satisfaction

    Patient satisfaction by five point Likert-Like verbal rating scale by asking the patient how they evaluate the experience with the analgesic management after the the surgery? (5-very satisfied, 4-satisfied, 3-neutral, 2-dissatisfied, 1-very dissatisfied)

    Measured: within 24 hours postoperative

  4. pain intensity at rest (static)

    measured by VAS on 0-10 cm scale (0- no pain and 10-the worst pain)

    Measured: measured immediately preoperative 0 minute ( admission receiving area)

  5. pain intensity at rest (static)

    measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

    Measured: at 30 minutes postoperative

  6. pain intensity at rest (static)

    measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

    Measured: at 1 hour postoperative

  7. pain intensity at rest (static)

    measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

    Measured: at 2 hours postoperative

  8. pain intensity at rest (static)

    measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

    Measured: at 4 hours postoperative

  9. pain intensity at rest (static)

    measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

    Measured: at 6 hours postoperative

  10. pain intensity at rest (static)

    measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

    Measured: at 8 hours postoperative

  11. pain intensity at rest (static)

    measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

    Measured: at 12 hours postoperative

  12. pain intensity at rest (static)

    measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

    Measured: at 18 hours postoperative

  13. pain intensity at rest (static)

    measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

    Measured: at 24 hours postoperative

  14. pain intensity on mobilization of operated knee (dynamic)

    measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

    Measured: measured immediately preoperative 0 minute ( admission receiving area)

  15. pain intensity on mobilization of operated knee (dynamic)

    measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

    Measured: at 30 minutes postoperative

  16. pain intensity on mobilization of operated knee (dynamic)

    measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

    Measured: at 1 hours postoperative

  17. pain intensity on mobilization of operated knee (dynamic)

    measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

    Measured: at 2 hours postoperative

  18. pain intensity on mobilization of operated knee (dynamic)

    measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

    Measured: at 4 hours postoperative

  19. pain intensity on mobilization of operated knee (dynamic)

    measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

    Measured: at 6 hours postoperative

  20. pain intensity on mobilization of operated knee (dynamic)

    measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

    Measured: at 8 hours postoperative

  21. pain intensity on mobilization of operated knee (dynamic)

    measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

    Measured: at 12 hours postoperative

  22. pain intensity on mobilization of operated knee (dynamic)

    measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

    Measured: at 18 hours postoperative

  23. pain intensity on mobilization of operated knee (dynamic)

    measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

    Measured: at 24 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2020
  2. Study start1 Jul 2020
  3. Primary completion1 Nov 2020
  4. Study completion1 Dec 2020

Resources

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
analgesia for postoperative pain after knee arthroscopy: dexmedetomidine+bupivacaine, fentanyl+bupivacaine , bupivacaine
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04442906
Sponsor's protocol ID
5355
Status last verified
Jan 2021
First submitted
19 Jun 2020
Last updated
25 Jan 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Salem DAE, Nabi SMA, Alagamy SA, Kamel AAF. Comparative Study Between Dexmedetomidine and Fentanyl as an Adjuvant to Intraarticular Bupivacaine for Postoperative Analgesia after Knee Arthroscopy. Pain Physician. 2021 Nov;24(7):E989-E996.

    PubMed 34704709

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine, Fentanyl and Bupivacain in people with Analgesia, 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 3 inclusion and 3 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 25 Jan 2021. 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?

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?

Duration of postoperative analgesia (time frame: For 24 hours postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04442906, which also lists 1 linked publication.

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 25 Jan 2021.

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