Clinical trial NCT04442906: Analgesia After Knee Arthroscopy :Dexmedetomidine vs Fentanyl
Official title: Comparative Study Between Dexmedetomidine and Fentanyl as an Adjuvant to Intra-articular Bupivacaine for Postoperative Analgesia After Knee Arthroscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: dexmedetomidine
fentanyl
bupivacaine
knee arthroscopy
postoperative analgesia
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-06-23
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: analgesia for postoperative pain after knee arthroscopy: dexmedetomidine+bupivacaine, fentanyl+bupivacaine , bupivacaine
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of postoperative analgesia
timeFrame: For 24 hours postoperative
Secondary outcomes:
measure: total dose of rescue analgesia ( pethidine)
timeFrame: within 24 hours postoperative
measure: The number of participants with bradycardia, itching and hypotension
timeFrame: Within 24 hours postoperative
measure: patient satisfaction
timeFrame: within 24 hours postoperative
measure: pain intensity at rest (static)
timeFrame: measured immediately preoperative 0 minute ( admission receiving area)
measure: pain intensity at rest (static)
timeFrame: at 30 minutes postoperative
measure: pain intensity at rest (static)
timeFrame: at 1 hour postoperative
measure: pain intensity at rest (static)
timeFrame: at 2 hours postoperative
measure: pain intensity at rest (static)
timeFrame: at 4 hours postoperative
measure: pain intensity at rest (static)
timeFrame: at 6 hours postoperative
measure: pain intensity at rest (static)
timeFrame: at 8 hours postoperative
measure: pain intensity at rest (static)
timeFrame: at 12 hours postoperative
measure: pain intensity at rest (static)
timeFrame: at 18 hours postoperative
measure: pain intensity at rest (static)
timeFrame: at 24 hours postoperative
measure: pain intensity on mobilization of operated knee (dynamic)
timeFrame: measured immediately preoperative 0 minute ( admission receiving area)
measure: pain intensity on mobilization of operated knee (dynamic)
timeFrame: at 30 minutes postoperative
measure: pain intensity on mobilization of operated knee (dynamic)
timeFrame: at 1 hours postoperative
measure: pain intensity on mobilization of operated knee (dynamic)
timeFrame: at 2 hours postoperative
measure: pain intensity on mobilization of operated knee (dynamic)
timeFrame: at 4 hours postoperative
measure: pain intensity on mobilization of operated knee (dynamic)
timeFrame: at 6 hours postoperative
measure: pain intensity on mobilization of operated knee (dynamic)
timeFrame: at 8 hours postoperative
measure: pain intensity on mobilization of operated knee (dynamic)
timeFrame: at 12 hours postoperative
measure: pain intensity on mobilization of operated knee (dynamic)
timeFrame: at 18 hours postoperative
measure: pain intensity on mobilization of operated knee (dynamic)
timeFrame: at 24 hours postoperative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university
Study officials:
affiliation: faculty of medicine , Zagazig University
name: Dina Salem, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.