Analgesic Effect Of Intra-articular Bupivacaine Fentanyl for Postoperative Pain Relief in Knee Arthroscopic Surgery

Study Overview
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Brief Summary
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However, local anesthetic agents can produce analgesia for a limited time when used as a single injection. Bupivacaine is a local anesthetic that has an immediate action on pain by blocking peripheral afferents. However, as the ideal analgesic, the drug must cover the whole postoperative period (≥ 24 hours); therefore, bupivacaine is usually combined with many adjutants to provide long-lasting post-arthroscopy analgesia.

Detailed Description
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Intr-articular drug administration has gained popularity because of its simplicity and efficacy in achieving anesthesia for diagnostic and operative arthroscopy and for providing postoperative analgesia .although the knee joint has been examined most commonly, arthroscopy of other joints such as shoulder, ankle, wrist, metatarsophalangeal and temporomandibular joints is being increasingly used. Intra-articular installation of local anesthesia during arthroscopic procedures has been used by many orthopedic surgeons to provide pain relief after surgery.The aim of this study was to evaluate the analgesic efficacy of intra-articular dexamethasone versus fentanyl added as an adjuvant to bupivacaine in patients undergoing knee arthroscopic surgery

Official Title
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Analgesic Effect Of Intra-articular Dexamethasone Versus Fentanyl Added as an Adjuvant to Bupivacaine for Postoperative Pain Relief in Knee Arthroscopic Surgery

Conditions
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Knee Arthroscopic Surgery

Intervention / Treatment
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* Drug: Group DB/Dexamethasone-Bupivacaine
* Drug: Group FB /Fentanyl-Bupivacaine
* Drug: Group PB/Placebo-Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical status (ASA) I or II Exclusion Criteria: Contraindication to spinal anesthesia. Allergy to the study drugs. Refusal of the patients.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group DB/Dexamethasone-Bupivacaine<br>Patients were received an intra-articular injection of 8mg dexamethasone added to18mL of 0.25% bupivacaine | Drug: Group DB/Dexamethasone-Bupivacaine<br>* The patient were received an intra-articular injection of 18ml bupivacaine 0.25% added to 8mg dexamethasone.<br>|
| Active Comparator: Group FB /Fentanyl-Bupivacaine<br>Patients were received an intra-articular injection of 1 ug/kg fentanyl added to 18 mL of 0.25% bupivacaine | Drug: Group FB /Fentanyl-Bupivacaine<br>* The patient were received an intra-articular injection of 1 ug/kg fentanyl added to 18ml of 0.25% bupivacaine.<br>|
| Placebo Comparator: Group PB/Placebo-Bupivacaine<br>Patients were received an intra-articular injection of 2 mL isotonic saline added to 18 mL of 0.25% bupivacaine | Drug: Group PB/Placebo-Bupivacaine<br>* Patients were received an intra-articular injection of 2ml isotonic saline added to 18ml of 0.25% bupivacaine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of postoperative analgesia | Time to the first request of pethidine in minutes within the first 24 hours postoperatively | for 24 hour after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total analgesic requirement | Total analgesic requirement of pethidine will be recorded during the first 24 hours following surgery | for 24 hour after surgery | 
| Mean arterial blood pressure | Mean arterial blood pressure measured in mm Hg and assessed at 1,2,4,6,8,12,18 and 24 hours following the discharge of the patient from the operating theatre. | At 1,2,4,6,8,12,18 and 24 hours postoperatively. | 
| Heart rate | Heart rate will be measured in beats/minute and assessed at 1,2,4,6,8,12,18 and 24 hours following the discharge of the patient from the operating theatre. | At 1,2,4,6,8,12,18 and 24 hours postoperatively. | 
| Pain score | Measured with visual analogue score(VAS):0=no pain and 100=worst imaginable pain measured at 1,2,4,6,8,12,18 and 24 hours | measured at 1,2,4,6,8,12,18 and 24 hours postoperatively. | 
| Patients' satisfaction | satisfaction score from 1 to 4; as 4=Excellent ,3=good ,2=satisfactory and 1=poor will be measured after 24 hours. | for 24 hour after surgery |