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The goal of this clinical trial is to compare the analgesic effect and safety of erector spinae plane block vs caudal epidural block in paediatric population undergoing lower limb cancer surgery. The main questions it aims to answer are:
This randomized parallel group clinical trial was carried out on 32 paediatric patients aged from 8 to 15 years old, both sexes, belonging to American Society of Anaesthesiologists II physical status, cancer patient receiving chemotherapy undergoing unilateral lower limb cancer surgery. Patients were divided into two equal groups: Group A: patients received selective unilateral ESPB and group B: patients received CEB. Both in conjunction with general anaesthesia. The primary outcomes were determining the postoperative time of first rescue analgesia and assessment of total postoperative morphine consumption using erector spinae block compared to CEB in the first 12 hours after surgery. The secondary outcomes were assessments of the pain severity intra- and post-operative parallel with recording any complication regarding drugs or procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group of patients received Caudal Epidural Analgesia | Active Comparator | Pediatric patients aged 8 to 15 years of age undergoing unilateral lower limb cancer surgery are recruited from National Cancer Institute & randomly allocated to this group. |
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| Group of patients received Erector Spinae Plane block | Active Comparator | Pediatric patients aged 8 to 15 years of age undergoing unilateral lower limb cancer surgery are recruited from National Cancer Institute & randomly allocated to this group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regional analgesia either CEA or ESP | Procedure | Ultrasound guided local anesthetic injection in the course of the conducting nerve to decrease pain transmission. |
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| Measure | Description | Time Frame |
|---|---|---|
| Determining the actual postoperative time of need for the first rescue analgesia | Compare the actual postoperative time of need for the first rescue analgesia by the Numerical Rating Score in all cases in both groups when it is equal to or more than 4. | Immediately and up to the first 12 hours post-operatively. |
| Assessment of total postoperative morphine consumption using erector spinae block compared to CEB in the first 12 hours after surgery. | Calculation of total postoperative morphine consumption in both groups. | Immediately and up to the first 12 hours post-operatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessments of the pain severity intra- and post-operatively. | Using Numerical Rating Score for postoperative pain assessment and vital data with fentanyl consumption for intraoperative pain assessment. | Intraoperatively and up to 12 hours postoperatively. |
| Recording any complication regarding drugs or procedures. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Atef Badran, MD | National cancer institute - Cairo university | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute | Cairo | ELkhalig | 11796 | Egypt |
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| ID | Term |
|---|---|
| D010268 | Parapsychology |
| ID | Term |
|---|---|
| D001525 | Behavioral Sciences |
| D004191 | Behavioral Disciplines and Activities |
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randomized parallel group clinical trial
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for example hypotension or local anaesthetic toxicity. |
| Intraoperatively and up to 12 hours postoperatively. |