Paravertebral Calcitonin in Thoracotomy

Thoracotomy Clinical Trial

Official title:

The Analgesic Value of Paravertebral Calcitonin in Patients Undergoing Thoracotomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06330168
• Other study ID #: 36264PR573/2/24
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2024
• Est. completion date: April 10, 2025

Study information

• Verified date: February 2024
• Source: Tanta University
• Contact: Osama M Rehab, MD
• Phone: 01095210806
• Email: osamarehab[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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, we conducted this study as we hypothesize 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: April 10, 2025
• Est. primary completion date: April 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thoracotomy

Intervention

Drug:
• bupivacaine-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).
• Bupivacaine-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%.

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	Gharbiya

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morphine consumption	total morphine consumption in the first 24 hours after surgery	from the end of surgery until the end of the first postoperative day
Secondary	numerical rating scale scores	A 0-10 cm 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	from arrival to the post-anesthesia care unit until 48 hour after surgery.
Secondary	incidence of chronic pain	chronic pain at 3 and 6 months after surgery	3 months and 6 months after surgery
Secondary	Side effects	hypotension, postoperative nausea and vomiting	first postoperative day