CalcitoninNCT06330168
Paravertebral Calcitonin in Thoracotomy
A study testing bupivacaine-calcitonin-fentanyl and Bupivacaine-fentanyl in people with Calcitonin and Paravertebral, run by Tanta University at 1 site in Egypt.
Trial summary
This prospective randomized double-blinded controlled study will be conducted to evaluate the effect of adding calcitonin to bupivacaine in thoracic paravertebral block for patients undergoing thoracotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcitonin, Paravertebral, Thoracotomy
- What is being tested?
- bupivacaine-calcitonin-fentanyl and Bupivacaine-fentanyl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Mar 2024to 15 May 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged ≥ 18 years
- American society of anesthesiology (ASA) physical status of I-III
- scheduled for elective thoracotomy
Who cannot join
- Contraindication to thoracic paravertebral block as coagulopathy or local anesthetic allergy.
- Pregnancy
- History of cardiovascular and gastro-esophageal surgery
- Preexisting pain syndrome or psychological disorders
- Severe hepatic, cardiovascular, or renal disorders
- Allergy to calcitonin
- Patients who will be re-operated and who will report infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Analgesic Value of Paravertebral Calcitonin in Patients Undergoing Thoracotomy
This prospective randomized double-blinded controlled study will be conducted to evaluate the effect of adding calcitonin to bupivacaine in thoracic paravertebral block for patients undergoing thoracotomy.
Read the detailed description
Single-shot thoracic paravertebral block combined with intravenous analgesia is one of the regional techniques used for controlling pain in patients undergoing thoracic surgery. However, few articles demonstrated its effects on acute pain and chronic pain after thoracotomy and revealed high postoperative opioid consumption and inability to reduce the incidence of chronic pain.
Calcitonin has previously been shown to be effective in the management of acute pain following amputation, vertebral fractures and other neuropathic conditions.
Using calcitonin as an additive in thoracic paravertebral block was not evaluated in previous studies, investigators conducted this study based on the hypothesis that calcitonin use as an additive in thoracic paravertebral block for patients undergoing thoracotomy may have extended analgesic effects regarding decreasing postoperative pain scores, opioid consumption, and this value may decrease the incidence of chronic post-thoracotomy pain.
In both groups, ultrasound-guided thoracic paravertebral block will be performed before anesthetic induction using a high-frequency linear probe after identifying the paravertebral space of the proposed level of intercostal skin incision.General anesthesia in both groups will be similar.
- Conditions
- Calcitonin, Paravertebral, Thoracotomy
- Being tested
- bupivacaine-calcitonin-fentanyl, Bupivacaine-fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine-calcitonin-fentanylDrug
pre-induction single shot thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 100 IU of calcitonin (1ml).
Bupivacaine-fentanylDrug
pre-induction single shot thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 1 ml saline 0.9%.
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine-calcitonin-fentanyl group | Experimental | thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 100 IU of calcitonin (1ml) Receives: Drug: bupivacaine-calcitonin-fentanyl |
| bupivacaine-fentanyl group | Placebo comparator | thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 1 ml saline 0.9%. Receives: Drug: Bupivacaine-fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
Total morphine dose consumed in the first 24 hour after surgery
Measured: from the end of surgery until the end of the first postoperative day
Incidence of chronic pain at 3 months after surgery
chronic pain at 3 months after surgery
Measured: 3 months after surgery
Secondary outcomes (5)
numerical rating scale scores
A 0-10 numerical rating scale ( 0 means no pain and 10 means the worst pain) at coughing and at rest will be assessed by an investigator during the first and second day post operation
Measured: from arrival to the post-anesthesia care unit until 48 hour after surgery.
incidence of chronic pain
chronic pain at 6, 9, and 12 months after surgery
Measured: 12 months after surgery
Side effects
hypotension, postoperative nausea and vomiting
Measured: first postoperative day
Intensity of chronic pain
Chronic pain intensity will be assessed at 3, 6, 9, and 12 months after surgery using A 0-10 numerical rating scale (0 means no pain and 10 means the worst pain)
Measured: 12 months after surgery
morphine consumption
Total morphine dose consumed during the second postoperative day
Measured: 48 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 posted26 Mar 2024
- Study start28 Mar 2024
- Primary completion14 May 2025
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CalcitoninStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Rehab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330168
- Sponsor's protocol ID
- 36264PR573/2/24
- Status last verified
- May 2026
- First submitted
- 19 Mar 2024
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Value of Paravertebral Calcitonin in Patients Undergoing Thoracotomy
- ClinicalTrials.gov ID
- NCT06330168
- Acronym / sponsor ID
- 36264PR573/2/24
- Conditions
- Calcitonin, Paravertebral, Thoracotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 26 Mar 2024 (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.
This prospective randomized double-blinded controlled study will be conducted to evaluate the effect of adding calcitonin to bupivacaine in thoracic paravertebral block for patients undergoing thoracotomy.
Detailed description
Single-shot thoracic paravertebral block combined with intravenous analgesia is one of the regional techniques used for controlling pain in patients undergoing thoracic surgery. However, few articles demonstrated its effects on acute pain and chronic pain after thoracotomy and revealed high postoperative opioid consumption and inability to reduce the incidence of chronic pain.
Calcitonin has previously been shown to be effective in the management of acute pain following amputation, vertebral fractures and other neuropathic conditions.
Using calcitonin as an additive in thoracic paravertebral block was not evaluated in previous studies, investigators conducted this study based on the hypothesis that calcitonin use as an additive in thoracic paravertebral block for patients undergoing thoracotomy may have extended analgesic effects regarding decreasing postoperative pain scores, opioid consumption, and this value may decrease the incidence of chronic post-thoracotomy pain.
In both groups, ultrasound-guided thoracic paravertebral block will be performed before anesthetic induction using a high-frequency linear probe after identifying the paravertebral space of the proposed level of intercostal skin incision.General anesthesia in both groups will be similar.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bupivacaine-calcitonin-fentanyl group | Experimental | Drug: bupivacaine-calcitonin-fentanylthoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 100 IU of calcitonin (1ml) |
| bupivacaine-fentanyl group | Placebo comparator | Drug: Bupivacaine-fentanylthoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 1 ml saline 0.9%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged ≥ 18 years
- American society of anesthesiology (ASA) physical status of I-III
- scheduled for elective thoracotomy
Key exclusion criteria (7 listed)
- Contraindication to thoracic paravertebral block as coagulopathy or local anesthetic allergy.
- Pregnancy
- History of cardiovascular and gastro-esophageal surgery
- Preexisting pain syndrome or psychological disorders
- Severe hepatic, cardiovascular, or renal disorders
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 |
|---|---|---|
| bupivacaine-calcitonin-fentanylpre-induction single shot thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 100 IU of calcitonin (1ml). | Drug | bupivacaine-calcitonin-fentanyl group |
| Bupivacaine-fentanylpre-induction single shot thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 1 ml saline 0.9%. | Drug | bupivacaine-fentanyl group |
Primary outcome
morphine consumption
Time frame: from the end of surgery until the end of the first postoperative day
Total morphine dose consumed in the first 24 hour after surgery
Incidence of chronic pain at 3 months after surgery
Time frame: 3 months after surgery
chronic pain at 3 months after surgery
5 secondary outcomes
numerical rating scale scores
Time frame: from arrival to the post-anesthesia care unit until 48 hour after surgery.
incidence of chronic pain
Time frame: 12 months after surgery
Side effects
Time frame: first postoperative day
Intensity of chronic pain
Time frame: 12 months after surgery
morphine consumption
Time frame: 48 hours after surgery
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 19 May 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the corresponding author
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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 study testing bupivacaine-calcitonin-fentanyl and Bupivacaine-fentanyl in people with Calcitonin and Paravertebral, run by Tanta 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 7 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 19 May 2026. 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.
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?
morphine consumption (time frame: from the end of surgery until the end of the first postoperative day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2026.