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Completed

NCT Number: NCT04445857

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

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain-Shams University Hospitals

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

coadministration of calcitonin intrathecally and a single-shot hyperbaric bupivacaine

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

Drug

coadministration of calcitonin intravenously and a single-shot hyperbaric bupivacaine

Normal Saline (NS)

Other

coadministration of normal saline and a single-shot hyperbaric bupivacaine

Primary outcomes

  1. The total dose of rescue analgesia (mg)

    Time frame: The first 24 hours after surgery

    The total dose of rescue analgesia (mg)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 24, 2020
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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