An interventional study of Dexmedetomidine and Fentanyl in Analgesia, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-25.
Sponsored by Zagazig University · Not applicable, Interventional, and Treatment
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.
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.
1,189 studies on the registry are indexed under Agnosia; 507 are open to participants now.
This study's enrollment of 45 is below the median of 77 across 1,023 interventional studies indexed under Agnosia.
Browse Agnosia studies →Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
IGroup B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline
Drug: Bupivacain
. Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).
Drug: Dexmedetomidine · Drug: Bupivacain
Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug).
Drug: Fentanyl · Drug: Bupivacain
Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).
Also known as: precedex
Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug)
Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline.
Also known as: marcaine
Duration of postoperative analgesia
start from intra-articular injection of the drug to the time of first request of analgesia
Time frame: For 24 hours postoperative
total dose of rescue analgesia ( pethidine)
total consumption of rescue analgesia (pethidine) postoperative
Time frame: within 24 hours postoperative
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 )
Time frame: Within 24 hours postoperative
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)
Time frame: within 24 hours postoperative
pain intensity at rest (static)
measured by VAS on 0-10 cm scale (0- no pain and 10-the worst pain)
Time frame: measured immediately preoperative 0 minute ( admission receiving area)
pain intensity at rest (static)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
Time frame: at 30 minutes postoperative
pain intensity at rest (static)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
Time frame: at 1 hour postoperative
pain intensity at rest (static)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
Time frame: at 2 hours postoperative
pain intensity at rest (static)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
Time frame: at 4 hours postoperative
pain intensity at rest (static)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
Time frame: at 6 hours postoperative
pain intensity at rest (static)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
Time frame: at 8 hours postoperative
pain intensity at rest (static)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
Time frame: at 12 hours postoperative
pain intensity at rest (static)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
Time frame: at 18 hours postoperative
pain intensity at rest (static)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
Time frame: at 24 hours postoperative
pain intensity on mobilization of operated knee (dynamic)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
Time frame: measured immediately preoperative 0 minute ( admission receiving area)
pain intensity on mobilization of operated knee (dynamic)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
Time frame: at 30 minutes postoperative
pain intensity on mobilization of operated knee (dynamic)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
Time frame: at 1 hours postoperative
pain intensity on mobilization of operated knee (dynamic)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
Time frame: at 2 hours postoperative
pain intensity on mobilization of operated knee (dynamic)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
Time frame: at 4 hours postoperative
pain intensity on mobilization of operated knee (dynamic)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
Time frame: at 6 hours postoperative
pain intensity on mobilization of operated knee (dynamic)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
Time frame: at 8 hours postoperative
pain intensity on mobilization of operated knee (dynamic)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
Time frame: at 12 hours postoperative
pain intensity on mobilization of operated knee (dynamic)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
Time frame: at 18 hours postoperative
pain intensity on mobilization of operated knee (dynamic)
measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
Time frame: at 24 hours postoperative
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Zagazig University