Immune Response of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery

Phase 2

Completed

• Conditions: Acute Pain
• Interventions: Drug: Bupivacaine; Drug: Tramadol

• Registration Number: NCT02703415
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-03-04
• Study First Submitted QC: 2016-03-04
• Study First Posted: 2016-03-09
• Study Start: 2016-06
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tramadol	Bupivacaine	caudal Tramadol
Tramadol	Tramadol	caudal Tramadol
Bupivacaine	Bupivacaine	caudal Bupivacaine

Primary Outcome Measures

Name	Time	Method
post operative immune response	within the first three days postoperatiely	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

Secondary Outcome Measures

Name	Time	Method
Time of first supplemental analgesia	within the first postoperative day	Time of first supplemental analgesia
. Post operative pain intensity	within the first postoperative day	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.
side effects	Within the first 24 hours	hypotension, vomiting, pruritus, urinary retention or motor weakness will be recorded.
Leucocyte count	within the first three days postoperatiely	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
sedation score	Within the first 24 hours	Sedation assessment after extubation by Richmond Agitation Sedation Scale (RASS)

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt