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

NCT04445857 | Completed Phase 4

• 1 other identifier: IRB 6379
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• The total dose of rescue analgesia (mg)

  The total dose of rescue analgesia (mg)

  The first 24 hours after surgery

Study Arms (3)

Group 1

ACTIVE COMPARATOR

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.

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

Group 2

ACTIVE COMPARATOR

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.

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

Group 3 (control group)

PLACEBO COMPARATOR

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.

Other: Normal Saline (NS)

Interventions

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

coadministration of calcitonin intrathecally and a single-shot hyperbaric bupivacaine

Group 1

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

coadministration of calcitonin intravenously and a single-shot hyperbaric bupivacaine

Group 2

Normal Saline (NS) OTHER

coadministration of normal saline and a single-shot hyperbaric bupivacaine

Group 3 (control group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain-Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: June 24, 2020
• Study Start: September 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

EG (1)