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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04445857

Enrollment

Registered

2020-06-24

Start date

2020-09-01

Completion date

2021-01-31

Last updated

2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia

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.

Interventions

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

coadministration of calcitonin intrathecally and a single-shot hyperbaric bupivacaine

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

coadministration of calcitonin intravenously and a single-shot hyperbaric bupivacaine

OTHERNormal Saline (NS)

coadministration of normal saline and a single-shot hyperbaric bupivacaine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026