Immune Response of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery

Study Overview
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Brief Summary
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Management of acute pain is one of the most important tasks of perioperative pediatric anesthesia. The alleviation of pain has been defined by the Society of Pediatric Anesthesia, on its 15th annual meeting as a basic human right, irrespective of age, treatment primary service responsible for the patient care. Pro-inflammatory cytokines increased by surgical trauma indirectly modulate pain through the release of substances like nitric oxide, oxygen free radicals, prostaglandins, and excitatory amino acids, inducing peripheral and central sensitivity and hyperalgesia. There has been growing interest in determining the possible immune consequences of analgesic administration for the management of postoperative pain

Detailed Description
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60 children aged 3-10 years undergoing lower abdominal surgery will be randomized into 2 groups (30 patients in each group) to receive caudal block with bupivacaine (0.25%) 1mg/kg (group 1) plus tramadol 1mg/kg (group 2) just after the induction of general anesthesia without premedication. All children will be assessed for the post operative immune response by measuring interleukin 6 and 10 (IL-6 and IL-10) and Tumour Necrosing Factor-α (TNF-α) using enzyme-linked immunosorbent assay (ELISA) technique one hour preoperatively and three hours after incision.

Official Title
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Comparison Of Immune Response And Analgesic Effects Of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Tramadol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: lower abdominal operation Exclusion Criteria: Any systemic disease that might compromise the immune system severe coagulation disorder true allergy to local anesthetics patients with major malformations of the lower spine or meninges any cutaneous or subcutaneous lesion at the site of injection unplanned reoperation, or reoperation within three months Diabetes Melliutes

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine<br>caudal Bupivacaine | Drug: Bupivacaine<br>* caudal block with bupivacaine (0.25%) 1mg/kg<br>* Other names: Marcaine;|
| Active Comparator: Tramadol<br>caudal Tramadol | Drug: Bupivacaine<br>* caudal block with bupivacaine (0.25%) 1mg/kg<br>* Other names: Marcaine;Drug: Tramadol<br>* caudal block with tramadol 1 mg/kg<br>* Other names: Tamol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative immune response | post operative immune response by measuring interleukin 6 (IL-6) using enzyme-linked immunosorbent assay (ELISA) technique, serum cortisol, C-reactive protein (CRP), and phopholipase A2 (PLA2) one hour preoperatively, end of anesthesia, 1st post- operative day, and 3rd post- operative day | within the first three days postoperatiely | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| . Post operative pain intensity | Post operative pain intensity with the FLACC pain scale for five categories (F) Face, (L) Legs, (A) Activity, (C) Cry, (C) consolability will be assessed. | within the first postoperative day | 
| Time of first supplemental analgesia | Time of first supplemental analgesia | within the first postoperative day | 
| sedation score | Sedation assessment after extubation by Richmond Agitation Sedation Scale (RASS) | Within the first 24 hours | 
| side effects | hypotension, vomiting, pruritus, urinary retention or motor weakness will be recorded. | Within the first 24 hours | 
| Leucocyte count | Leucocyte count and the percentages of neutrophils, lymphocytes and monocytes at one hour preoperatively, end of anesthesia, 1st post- operative day, and 3rd post- operative day | within the first three days postoperatiely | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immune, interleukin, tramadol, postoperartive analgesia, pediatric, caudal bupivacaine