Analgesia After Knee Arthroscopy :Dexmedetomidine vs Fentanyl

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04442906
• Other study ID #: 5355
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2021
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

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

Locations

Country	Name	City	State
Egypt	Zagazig university	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of postoperative analgesia	start from intra-articular injection of the drug to the time of first request of analgesia	For 24 hours postoperative
Secondary	total dose of rescue analgesia ( pethidine)	total consumption of rescue analgesia (pethidine) postoperative	within 24 hours postoperative
Secondary	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 )	Within 24 hours postoperative
Secondary	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)	within 24 hours postoperative
Secondary	pain intensity at rest (static)	measured by VAS on 0-10 cm scale (0- no pain and 10-the worst pain)	measured immediately preoperative 0 minute ( admission receiving area)
Secondary	pain intensity at rest (static)	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)	at 30 minutes postoperative
Secondary	pain intensity at rest (static)	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)	at 1 hour postoperative
Secondary	pain intensity at rest (static)	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)	at 2 hours postoperative
Secondary	pain intensity at rest (static)	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)	at 4 hours postoperative
Secondary	pain intensity at rest (static)	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)	at 6 hours postoperative
Secondary	pain intensity at rest (static)	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)	at 8 hours postoperative
Secondary	pain intensity at rest (static)	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)	at 12 hours postoperative
Secondary	pain intensity at rest (static)	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)	at 18 hours postoperative
Secondary	pain intensity at rest (static)	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)	at 24 hours postoperative
Secondary	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 immediately preoperative 0 minute ( admission receiving area)
Secondary	pain intensity on mobilization of operated knee (dynamic)	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)	at 30 minutes postoperative
Secondary	pain intensity on mobilization of operated knee (dynamic)	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)	at 1 hours postoperative
Secondary	pain intensity on mobilization of operated knee (dynamic)	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)	at 2 hours postoperative
Secondary	pain intensity on mobilization of operated knee (dynamic)	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)	at 4 hours postoperative
Secondary	pain intensity on mobilization of operated knee (dynamic)	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)	at 6 hours postoperative
Secondary	pain intensity on mobilization of operated knee (dynamic)	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)	at 8 hours postoperative
Secondary	pain intensity on mobilization of operated knee (dynamic)	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)	at 12 hours postoperative
Secondary	pain intensity on mobilization of operated knee (dynamic)	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)	at 18 hours postoperative
Secondary	pain intensity on mobilization of operated knee (dynamic)	measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)	at 24 hours postoperative