AnalgesiaPhase 4NCT04445857
Efficacy of Coadministration of Calcitonin and Hyperbaric Bupivacaine in Spinal Anesthesia in Tramadol-abuse Patients
A Phase 4 study testing Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intrathecally, Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intravenously and Normal Saline (NS) in people with Analgesia, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intrathecally, Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intravenously and Normal Saline (NS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 31 Jan 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- coagulation disorder,
- history of uncontrolled hypertension,
- history of uncontrolled blood sugar,
- allergy to bupivacaine or calcitonin
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intrathecally, Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intravenously, Normal Saline (NS)
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intrathecallyDrug
coadministration of calcitonin intrathecally and a single-shot hyperbaric bupivacaine
Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intravenouslyDrug
coadministration of calcitonin intravenously and a single-shot hyperbaric bupivacaine
Normal Saline (NS)Other
coadministration of normal saline and a single-shot hyperbaric bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Normal Saline (NS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total dose of rescue analgesia (mg)
The total dose of rescue analgesia (mg)
Measured: The first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start1 Sep 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Mamdouh Esmat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445857
- Sponsor's protocol ID
- IRB 6379
- Status last verified
- Apr 2025
- First submitted
- 21 Jun 2020
- Last updated
- 8 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Esmat IM, Mohamed AK, Gad IA, Mohamed NR, Talaat SM, Shorbagy MS, Ashoor TM. Efficacy of coadministration of calcitonin and hyperbaric bupivacaine in spinal anesthesia for unilateral open inguinal hernia repair in tramadol abuse patients: a randomized controlled trial. BMC Anesthesiol. 2026 Mar 28;26(1):208. doi: 10.1186/s12871-026-03736-9.
PubMed 41896726
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04445857
- Acronym / sponsor ID
- IRB 6379
- Conditions
- Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 24 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intrathecallyinjection 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. |
| Group 2 | Active comparator | Drug: Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intravenouslyinjection 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. |
| Group 3 (control group) | Placebo comparator | Other: Normal Saline (NS)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intrathecallycoadministration of calcitonin intrathecally and a single-shot hyperbaric bupivacaine | Drug | Group 1 |
| Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intravenouslycoadministration of calcitonin intravenously and a single-shot hyperbaric bupivacaine | Drug | Group 2 |
| Normal Saline (NS)coadministration of normal saline and a single-shot hyperbaric bupivacaine | Other | Group 3 (control group) |
Primary outcome
The total dose of rescue analgesia (mg)
Time frame: The first 24 hours after surgery
The total dose of rescue analgesia (mg)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Derived from this study: PubMed 41896726Esmat IM, Mohamed AK, Gad IA, Mohamed NR, Talaat SM, Shorbagy MS, Ashoor TM. Efficacy of coadministration of calcitonin and hyperbaric bupivacaine in spinal anesthesia for unilateral open inguinal hernia repair in tramadol abuse patients: a randomized controlled trial. BMC Anesthesiol. 2026 Mar 28;26(1):208. doi: 10.1186/s12871-026-03736-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intrathecally, Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml) intravenously and Normal Saline (NS) in people with Analgesia, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total dose of rescue analgesia (mg) (time frame: The first 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04445857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.