Comparison the Effects of 3 Different Intraarticular Ketamine Doses on Postoperative Pain.

Study Overview
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Brief Summary
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the aim is to compare the effects of two different doses of intraarticular ketamine on postoperative pain scores and analgesic requirements.in knee artroscopy

Detailed Description
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All pateints are going to be operated under general anesthesia. At the end of the study patients are going to be randomyl seperated into 3 groups. The surgeon is going the following drugs intraarticulary. Group KL1: 0.5 mg/kg ketamin in % 0..9 NaCl at a total volume of 20 ml Group KL2: 1 mg/kg ketamin in % 0.9 NaCl at a total volume of 20 ml Group SL: 20 ml % 0.9 NaCl ll patients are going to receive a periarticula injection of 10 ml 0.5 bupivacaine and patient controlled analgesia with morphine. VAS scores and total analgesic requirement is going to be evaluated.

Official Title
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Effects of İntraarticular and Periarticular Applied Drugs on Postoperative Pain Management in Artroscopic Knee Surgery for

Conditions
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Arthroscopy

Intervention / Treatment
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* Drug: Ketamine 0.5
* Drug: Ketamine 1
* Drug: % 0.9 NaCl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Artroscopic surgery ASA I-II Exclusion Criteria: Long time NSAID use Travmatic knee injury Long ter analgesic use Intraartiular catheter insertion at the end of surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketamine 0.5 mg/kg<br>ketamin 0.5 mg/kg intraarticular | Drug: Ketamine 0.5<br>* İntrarticular Ketamine 0.5 mg/kg + 0.9 Nacl Total Volume 20 ml<br>* Other names: Group 1;|
| Active Comparator: Ketamine 1 mg/kg<br>ketamin 1 mg/kg intraarticular injection | Drug: Ketamine 1<br>* İntrarticular Ketamine 1 mg/kg + 0.9 NaCl Total Volume 20 ml<br>* Other names: Group 2;|
| Sham Comparator: % 0.9 Saline<br>% 0.9 NaCL intraarticular injection | Drug: % 0.9 NaCl<br>* Intraarticular %0.9 NaCl<br>* Other names: Group 3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postoperative pain scores throughout time evaluated by VAS | Pain scores are going to be evaluated by VAS scores at rest and VAS scores at activity | VAS scores at rest and during activity will be evaluated for 24 hours. The first measurement will be recorded immediately after surgery and at 30 minutes interval for the first hour. Afterwards at 2.4.6.12.24.hours postoperatively. | 
| Difference in opioid Sparing effect measured through morphine amount delivered by a patient controlled analgesia device. | The total amount of morphine delivered by the patient controlled analgesia device in the first 24 hours will be recorded. | Total amount off delivered morphine will be recorded for 24 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for discharge measured by eligible for discharge criteria | The time needed to fullfill the dicharge criteria (stable vital signs, able to walk, able to eat, nausea and vomit free, able to mixture) | Discharge criterias will be evaluated every three hours until postoperative 24. hour. In patients who did not complete the discharge criteria in the postoperative 24 hours period, they will be defined as prolonged discharge. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Injection, Intra-Articular, arthroscopy, ketamine