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

Phase 4

Completed

• Conditions: Analgesia
• Interventions: Drug: Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intrathecally; Drug: Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intravenously; Other: Normal Saline (NS)

• Registration Number: NCT04445857
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-21
• Study First Submitted QC: 2020-06-23
• Study First Posted: 2020-06-24
• Study Start: 2020-09-01
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-28
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	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	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)	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.

Primary Outcome Measures

Name	Time	Method
The length of the sensory block (min) of spinal anesthesia in tramadol-abuse patients intrathecally or i.v.	procedure	The length of the sensory block (min) of spinal anesthesia in tramadol-abuse patients intrathecally or i.v.

Trial Locations

Locations (1)

Ibrahim Mamdouh Esmat; 🇪🇬 Cairo, Married, Egypt