DRUG
Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intrathecally
coadministration of calcitonin intrathecally and a single-shot hyperbaric bupivacaine
Efficacy of Coadministration of Calcitonin and Hyperbaric Bupivacaine in Spinal Anesthesia in Tramadol-abuse Patients
Status
Completed
Phase
Phase 4
Enrollment
90
Locations
1
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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
Treatment arms and agents.
DRUG
Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intravenously
coadministration of calcitonin intravenously and a single-shot hyperbaric bupivacaine
OTHER
Normal Saline (NS)
coadministration of normal saline and a single-shot hyperbaric bupivacaine
Timeline
From registration to results.
First posted
Jun 24, 2020
Study start
Sep 1, 2020
Primary completion
Jan 31, 2021
Study completion
Jan 31, 2021
Results posted
Not reported
Registry updated
Apr 8, 2025
Outcomes
What the study measures.
Primary outcomes
The total dose of rescue analgesia (mg)
Time frame · The first 24 hours after surgery
The total dose of rescue analgesia (mg)
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Sex
- ALL
- Healthy volunteers
- No
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 locations
1 registered sites.
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Ain-Shams University Hospitals
Cairo, Egypt
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.