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NCT Number: NCT06330168

Paravertebral Calcitonin in 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.

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Key information

Conditions

Calcitonin Paravertebral Thoracotomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, Gharbia Governorate, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

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

Treatment and study plan

bupivacaine-calcitonin-fentanyl

Drug

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-fentanyl

Drug

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

Primary outcomes

  1. 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

  2. Incidence of chronic pain at 3 months after surgery

    Time frame: 3 months after surgery

    chronic pain at 3 months after surgery

Secondary outcomes

  1. numerical rating scale scores

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

    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

  2. incidence of chronic pain

    Time frame: 12 months after surgery

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

  3. Side effects

    Time frame: first postoperative day

    hypotension, postoperative nausea and vomiting

  4. Intensity of chronic pain

    Time frame: 12 months after surgery

    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)

  5. morphine consumption

    Time frame: 48 hours after surgery

    Total morphine dose consumed during the second postoperative day

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

The Analgesic Value of Paravertebral Calcitonin in Patients Undergoing Thoracotomy

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 26, 2024
Registry last updated
May 19, 2026

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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