Paravertebral Calcitonin in Thoracotomy

NCT06330168 | Active Not Recruiting

• 1 other identifier: 36264PR573/2/24
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Calcitonin; Paravertebral; Thoracotomy

Outcome Measures

Primary Outcomes (2)

• morphine consumption

  Total morphine dose consumed in the first 24 hour after surgery

  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

  3 months after surgery

Secondary Outcomes (5)

• numerical rating scale scores

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

• incidence of chronic pain

  12 months after surgery

• Side effects

  first postoperative day

• Intensity of chronic pain

  12 months after surgery

• morphine consumption

  48 hours after surgery

Study Arms (2)

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)

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%.

Drug: Bupivacaine-fentanyl

Interventions

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-calcitonin-fentanyl group

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%.

bupivacaine-fentanyl group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbia Governorate, 31527, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: triple
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesiology, surgical intensive care and pain medicine Tanta university

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: March 28, 2024
• Primary Completion: May 14, 2025
• Study Completion (Estimated): May 15, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After completion of the study
• Access Criteria: The data will be available upon reasonable request from the corresponding author

Locations

EG (1)