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Increasing duration of local anesthetic action is desired for prolongation of postoperative patient comfort, as well as decreasing perioperative opioid consumption and subsequent side effects. Calcitonin, discovered in 1961, has been established, synthesized, and developed for use in treating disease. In 1983 it was demonstrated that calcitonin is an analgesic, which is also effective in the epidural and subarachnoid spaces.Tramadol abuse has dramatically increased in Egypt since 2008 and has led to many admissions to addiction treatment centers.It was shown that the duration of sensory block of spinal anesthesia with hyperbaric bupivacaine in chronic opium abusers undergoing lower extremity orthopedic surgery was much shorter in chronic opium abusers compared with non-abusers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | injection of 15 mg (3 ml) hyperbaric bupivacaine 0.5% and 100 IU salmon calcitonin(1ml) intrathecally and injection of 10 ml normal saline (NS) slowly intravenously (IV) over 5 min. |
|
| Group 2 | Active Comparator | injection of 15 mg (3 ml) hyperbaric bupivacaine 0.5% and 1ml NS intrathecally and injection of 100 IU salmon calcitonin (1ml) diluted in 9 ml NS slowly IV over 5 min. |
|
| Group 3 (control group) | Placebo Comparator | injection of 15 mg (3 ml) hyperbaric bupivacaine 0.5% and 1ml NS intrathecally and injection of 10 ml NS slowly IV over 5 min. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcitonin presented as MiacalcicĀ® ampoules 100 IU/ml (1ml) intrathecally | Drug | coadministration of calcitonin intrathecally and a single-shot hyperbaric bupivacaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| The total dose of rescue analgesia (mg) | The total dose of rescue analgesia (mg) | The first 24 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain-Shams University Hospitals | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41896726 | Derived | Esmat IM, Mohamed AK, Gad IA, Mohamed NR, Talaat SM, Shorbagy MS, Ashoor TM. Efficacy of coadministration of calcitonin and hyperbaric bupivacaine in spinal anesthesia for unilateral open inguinal hernia repair in tramadol abuse patients: a randomized controlled trial. BMC Anesthesiol. 2026 Mar 28;26(1):208. doi: 10.1186/s12871-026-03736-9. |
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| Calcitonin presented as MiacalcicĀ® ampoules 100 IU/ml (1ml) intravenously | Drug | coadministration of calcitonin intravenously and a single-shot hyperbaric bupivacaine |
|
| Normal Saline (NS) | Other | coadministration of normal saline and a single-shot hyperbaric bupivacaine |
|
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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