Analgesia After Knee Arthroscopy :Dexmedetomidine vs Fentanyl

Not Applicable

Completed

• Conditions: Analgesia
• Interventions: Drug: Bupivacain; Drug: Dexmedetomidine; Drug: Fentanyl

• Registration Number: NCT04442906
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-20
• Study First Posted: 2020-06-23
• Study Start: 2020-07-01
• Primary Completion: 2020-11-01
• Study Completion: 2020-12-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B	Bupivacain	IGroup B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline
group BD	Bupivacain	. Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).
group BF	Bupivacain	Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug).
group BD	Dexmedetomidine	. Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).
group BF	Fentanyl	Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug).

Primary Outcome Measures

Name	Time	Method
Duration of postoperative analgesia	For 24 hours postoperative	start from intra-articular injection of the drug to the time of first request of analgesia

Secondary Outcome Measures

Name	Time	Method
total dose of rescue analgesia ( pethidine)	within 24 hours postoperative	total consumption of rescue analgesia (pethidine) postoperative
pain intensity at rest (static)	at 24 hours postoperative	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
The number of participants with bradycardia, itching and hypotension	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 )
patient satisfaction	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)
pain intensity on mobilization of operated knee (dynamic)	at 24 hours postoperative	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)

Trial Locations

Locations (1)

Zagazig university; 🇪🇬 Zagazig, Egypt