Efficacy of Coadministration of Calcitonin and Hyperbaric Bupivacaine on Spinal Anesthesia in Tramadol-abuse Patients

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Coadministration of Calcitonin and Hyperbaric Bupivacaine on Spinal Anesthesia in Lower Abdominal and Limb Surgeries in Tramadol-abuse Patients: a Randomized Controlled Trial

Conditions
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Analgesia

Intervention / Treatment
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* Drug: Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml)
* Other: normal saline (NS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with history of substance use disorders (SUD) history of tramadol addiction (single drug addiction and substances used besides tramadol) 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 or failed spinal.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>injection of 15 mg (2.5 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. | Drug: Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml)<br>* coadministration of calcitonin and a single-shot hyperbaric bupivacaine prolongs the length of the sensory block (min) of SA in tramadol-abuse patients independent of the route of calcitonin administration intrathecally or i.v.<br>Other: normal saline (NS)<br>* 1ml NS intrathecally OR injection of 10 ml NS slowly IV over 5 min.<br>|
| Active Comparator: Group 2<br>injection of 15 mg (2.5 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. | Drug: Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml)<br>* coadministration of calcitonin and a single-shot hyperbaric bupivacaine prolongs the length of the sensory block (min) of SA in tramadol-abuse patients independent of the route of calcitonin administration intrathecally or i.v.<br>Other: normal saline (NS)<br>* 1ml NS intrathecally OR injection of 10 ml NS slowly IV over 5 min.<br>|
| Placebo Comparator: Group 3 (control group)<br>injection of 15 mg (2.5 ml) hyperbaric bupivacaine 0.5% and 1ml NS intrathecally and injection of 10 ml NS slowly IV over 5 min. | Other: normal saline (NS)<br>* 1ml NS intrathecally OR injection of 10 ml NS slowly IV over 5 min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The length of the sensory block (min) of spinal anesthesia in tramadol-abuse patients intrathecally or i.v. | The length of the sensory block (min) of spinal anesthesia in tramadol-abuse patients intrathecally or i.v. | procedure |