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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Analgesia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04445857

IRB 6379

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Group 1

Active Comparator group

Description:

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.

Treatment:

Drug: Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intrathecally

Group 2

Active Comparator group

Description:

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.

Treatment:

Drug: Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intravenously

Group 3 (control group)

Placebo Comparator group

Description:

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.

Treatment:

Other: Normal Saline (NS)