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Completed

NCT Number: NCT04442906

Analgesia After Knee Arthroscopy :Dexmedetomidine vs Fentanyl

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.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig university

Zagazig, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: precedex

Fentanyl

Drug

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

Bupivacain

Drug

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

Other names: marcaine

Primary outcomes

  1. Duration of postoperative analgesia

    Time frame: For 24 hours postoperative

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

Secondary outcomes

  1. total dose of rescue analgesia ( pethidine)

    Time frame: within 24 hours postoperative

    total consumption of rescue analgesia (pethidine) postoperative

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

    Time frame: Within 24 hours postoperative

    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 )

  3. patient satisfaction

    Time frame: within 24 hours postoperative

    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)

  4. pain intensity at rest (static)

    Time frame: measured immediately preoperative 0 minute ( admission receiving area)

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

  5. pain intensity at rest (static)

    Time frame: at 30 minutes postoperative

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

  6. pain intensity at rest (static)

    Time frame: at 1 hour postoperative

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

  7. pain intensity at rest (static)

    Time frame: at 2 hours postoperative

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

  8. pain intensity at rest (static)

    Time frame: at 4 hours postoperative

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

  9. pain intensity at rest (static)

    Time frame: at 6 hours postoperative

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

  10. pain intensity at rest (static)

    Time frame: at 8 hours postoperative

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

  11. pain intensity at rest (static)

    Time frame: at 12 hours postoperative

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

  12. pain intensity at rest (static)

    Time frame: at 18 hours postoperative

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

  13. pain intensity at rest (static)

    Time frame: at 24 hours postoperative

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

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

    Time frame: measured immediately preoperative 0 minute ( admission receiving area)

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

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

    Time frame: at 30 minutes postoperative

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

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

    Time frame: at 1 hours postoperative

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

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

    Time frame: at 2 hours postoperative

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

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

    Time frame: at 4 hours postoperative

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

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

    Time frame: at 6 hours postoperative

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

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

    Time frame: at 8 hours postoperative

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

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

    Time frame: at 12 hours postoperative

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

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

    Time frame: at 18 hours postoperative

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

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

    Time frame: at 24 hours postoperative

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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 23, 2020
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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