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

Ain Shams University90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Analgesia

Interventions

coadministration of calcitonin intrathecally and a single-shot hyperbaric bupivacaine

Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intravenouslyDRUG

coadministration of calcitonin intravenously and a single-shot hyperbaric bupivacaine

Normal Saline (NS)OTHER

coadministration of normal saline and a single-shot hyperbaric bupivacaine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Ain-Shams University Hospitals

Cairo, Egypt

Outcomes

Primary Outcomes

The total dose of rescue analgesia (mg)

Time frame: The first 24 hours after surgery

Data from ClinicalTrials.gov

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