Analgesia After Knee Arthroscopy :Dexmedetomidine vs Fentanyl

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Analgesia

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Fentanyl
* Drug: Bupivacain


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: analgesia for postoperative pain after knee arthroscopy: dexmedetomidine+bupivacaine, fentanyl+bupivacaine , bupivacaine
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group B<br>IGroup B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline | Drug: Bupivacain<br>* Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline.<br>* Other names: marcaine;|
| Active Comparator: group BD<br>. Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug). | Drug: Dexmedetomidine<br>* Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).<br>* Other names: precedex;Drug: Bupivacain<br>* Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline.<br>* Other names: marcaine;|
| Active Comparator: group BF<br>Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug). | Drug: Fentanyl<br>* Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug)<br>Drug: Bupivacain<br>* Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline.<br>* Other names: marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total dose of rescue analgesia ( pethidine) | total consumption of rescue analgesia (pethidine) postoperative | 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 ) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | at 24 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexmedetomidine, fentanyl, bupivacaine, knee arthroscopy, postoperative analgesia