Comparing Three Different Doses of Intrathecal Ketamine

Study Overview
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Brief Summary
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The aim of this study is to compare the postoperative analgesic effect of three different doses of intrathecal ketamine as an adjuvant to bupivacaine in patients undergoing knee arthroscopy.

Detailed Description
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A meta-analysis of adult human randomized controlled studies that compared single dose perioperative intrathecal ketamine plus intrathecal bupivacaine to bupivacaine alone in spinal anesthesia suggests that there is a benefit to using intrathecal ketamine as an adjunct to bupivacaine in multimodal analgesia. However, there are still knowledge and experience gaps regarding neuraxial ketamine dosing in this regard. Aim of the study: The aim of this study is to compare the postoperative analgesic effect of three different doses of intrathecal ketamine as an adjuvant to bupivacaine in patients undergoing knee arthroscopy.

Official Title
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Analgesic Effects of Three Different Doses of Intrathecal Ketamine as an Adjuvant to Intrathecal Bupivacaine in Patients Undergoing Knee Arthroscopy. A Randomized Prospective Double-blinded Study

Conditions
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Ketamine Causing Adverse Effects in Therapeutic Use

Intervention / Treatment
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* Drug: Ketamine 0.1 mg
* Drug: Ketamine 0.2 mg
* Drug: Ketamine 0.3 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-70 years. BMI: 20-30 kg.m2 Sex: both males and females. ASA physical status: I-III. Operation: knee arthroscopy. Exclusion Criteria: Patient's refusal to participate in the study. Aged less than 18 years, known allergy to L.A., Coagulopathy or thrombocytopenia, height less than 150 cm, morbidly obese infection at the site of injection. Chronic pain syndromes, pregnant woman Patients on regular use of analgesic or who received analgesic 24 h before surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketamine 0.1<br>Group I: will include 35 patients, will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.1 mg/kg | Drug: Ketamine 0.1 mg<br>* Patients will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.1 mg/kg<br>|
| Active Comparator: Ketamine 0.2<br>Group II will include 35 patients, will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.2 mg/kg | Drug: Ketamine 0.2 mg<br>* will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.2 mg/kg<br>|
| Active Comparator: Ketamine 0.3<br>Group III will include 35 patients, will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.3 mg/kg | Drug: Ketamine 0.3 mg<br>* will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.3 mg/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first analgesic request | From the time of intrathecal administration of the drug to the time of patient needs the first rescue analgesic drug | First 24 hours |