Efficacy of Coadministration of Calcitonin and Hyperbaric Bupivacaine in Spinal Anesthesia in Lower Abdominal and Limb Surgeries in Tramadol-abuse Patients: a Randomized Controlled Trial
| Registry | NCT04445857 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 90 (Actual) |
| Sponsor | Ain Shams University (Other) |
| Conditions | Analgesia |
| Interventions | Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intrathecally, Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intravenously, Normal Saline (NS) (Drug, other) |
| Dates | start 2020-09-01, primary completion 2021-01-31, completion 2021-01-31, first posted 2020-06-24, last updated 2025-04-08 |
| Locations | 1 site in Egypt |
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All trials for Analgesia All trials of Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intrathecally All trials of Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intravenously
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group 1 | Active comparator | Drug: Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intrathecally | 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 | Drug: Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intravenously | 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 | Other: Normal Saline (NS) | 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. |
Sex: All, ages: 18 Years to 60 Years
Inclusion Criteria: * Patients with history of tramadol addiction (single drug addiction) and duration of addiction >1 year * Elective lower abdomen or lower extremities surgeries under spinal anesthesia * ASA physical status I and II Exclusion Criteria: * Patient's refusal, * duration of surgery more than 120 min, * obesity with body mass index (BMI) >35 kg/m2, * generalized infection or localized infection at level of blockade, * neurological disease, * psychological disorder * coagulation disorder, * history of uncontrolled hypertension, * history of uncontrolled blood sugar, * allergy to bupivacaine or calcitonin
| Facility | City | Country | Status |
|---|---|---|---|
| Ain-Shams University Hospitals | Cairo | Egypt |