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

• Status: Completed
• Trial end date: 2021-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Calcitonin; Calcitonin Gene-Related Peptide; Katacalcin; Salmon calcitonin

Criteria

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.