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CompletedNCT06330168Updated May 19, 2026

Paravertebral Calcitonin in Thoracotomy

An interventional study of bupivacaine-calcitonin-fentanyl and Bupivacaine-fentanyl in Calcitonin, Paravertebral and Thoracotomy, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by Tanta University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Calcitonin
  • Paravertebral
  • Thoracotomy
03

In context

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • aged ≥ 18 years
  • American society of anesthesiology (ASA) physical status of I-III
  • scheduled for elective thoracotomy

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    bupivacaine-calcitonin-fentanyl group

    thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 100 IU of calcitonin (1ml)

    Drug: bupivacaine-calcitonin-fentanyl

  • Placebo comparator
    bupivacaine-fentanyl group

    thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 1 ml saline 0.9%.

    Drug: Bupivacaine-fentanyl

Interventions

  • Drugbupivacaine-calcitonin-fentanyl

    pre-induction single shot thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 100 IU of calcitonin (1ml).

  • DrugBupivacaine-fentanyl

    pre-induction single shot thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 1 ml saline 0.9%.

06

What researchers measure

Primary outcomes

  1. morphine consumption

    Total morphine dose consumed in the first 24 hour after surgery

    Time frame: from the end of surgery until the end of the first postoperative day

  2. Incidence of chronic pain at 3 months after surgery

    chronic pain at 3 months after surgery

    Time frame: 3 months after surgery

Secondary outcomes

  1. 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

    Time frame: from arrival to the post-anesthesia care unit until 48 hour after surgery.

  2. incidence of chronic pain

    chronic pain at 6, 9, and 12 months after surgery

    Time frame: 12 months after surgery

  3. Side effects

    hypotension, postoperative nausea and vomiting

    Time frame: first postoperative day

  4. 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)

    Time frame: 12 months after surgery

  5. morphine consumption

    Total morphine dose consumed during the second postoperative day

    Time frame: 48 hours after surgery

07

Study locations

1 site
  • Tanta University Hospitals
    Tanta, Gharbia Governorate 31527, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon reasonable request from the corresponding author

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06330168
Lead sponsor
Tanta University
Responsible party
Osama Rehab (lecturer of anesthesiology, surgical intensive care and pain medicine Tanta university, Tanta University) — Principal investigator
First posted
Mar 26, 2024
Start date
Mar 28, 2024
Primary completion
May 14, 2025
Completion
May 15, 2026
Last update
May 19, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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