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

Efficacy of Coadministration of Calcitonin and Hyperbaric Bupivacaine in Spinal Anesthesia in Lower Abdominal and Limb Surgeries in Tramadol-abuse Patients: a Randomized Controlled Trial

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 Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: 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)

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain-Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; 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; coadministration of calcitonin intrathecally and a single-shot hyperbaric bupivacaine
Active Comparator: Group 2; 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; coadministration of calcitonin intravenously and a single-shot hyperbaric bupivacaine
Placebo Comparator: Group 3 (control group); 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); coadministration of normal saline and a single-shot hyperbaric bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total dose of rescue analgesia (mg)	The total dose of rescue analgesia (mg)	The first 24 hours after surgery

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: June 21, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 5, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents; Vasodilator Agents; Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
• Other Study ID Numbers: IRB 6379

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No