intrathecaم Ketamine, Morphine and Both for Lower Abdominal Cancer Surgery Pain

Study Overview
=================
Brief Summary
-----------------
this study investigates the analgesic efficacy and other possible effects of ketamine, morphine, and both together when administered intrathecally for control of postoperative pain following lower abdominal cancer surgeries.

Official Title
-----------------
Effects of Intrathecally Administered Ketamine, Morphine and Their Combination in Patients Undergoing Major Abdominal Cancer Surgery

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: intrathecal morphine
* Drug: intrathecal ketamine
* Drug: intrathecal morphine + ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesia (ASA) I-III patients. aged 30-50 years. scheduled for major abdominal cancer surgery. Exclusion Criteria: Patients with a known allergy to the study drugs. significant cardiac, respiratory, renal or hepatic disease. coagulation disorders. infection at or near the site of intrathecal injection. drug or alcohol abuse. BMI > 30 kg/m2. psychiatric illnesses that may interfere with perception and assessment of pain.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group I: morphine group<br>patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine in 1 ml volume intrathecally. | Drug: intrathecal morphine<br>* patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg intrathecal morphine1 ml volume.<br>|
| Active Comparator: group II: ketamine group<br>patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg ketamine in 1ml volume intrathecally. | Drug: intrathecal ketamine<br>* patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg intrathecal ketamine in 1ml volume.<br>|
| Active Comparator: group III: morphine + ketamine group<br>patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg morphine plus 0.1 mg/kg of Ketamine in 1 ml volume intrathecally. | Drug: intrathecal morphine + ketamine<br>* patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and intrathecal morphine + ketamine 0.3 mg and 0.1 mg/kg respectively in 1 ml volume.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) scores | postoperative pain measured by this score. | 24 hours postoperative | 
| time to first analgesic request | the time passed till the first request of rescue analgesia by the patients | 24 hours postoperative | 
| total analgesic consumption | the total amount of rescue analgesic drug used allover follow up period | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects | the type and rate of incidence of side effects during the follow up period | 24 hours postoperative |