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).
Status
Completed
Phase
Not applicable
Enrollment
92
Locations
1
Results
Not posted
Publications
0
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.
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.
Interventions
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).
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%.
Timeline
First posted
Mar 26, 2024
Study start
Mar 28, 2024
Primary completion
May 14, 2025
Study completion
May 15, 2026
Results posted
Not reported
Registry updated
May 19, 2026
Outcomes
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
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
incidence of chronic pain
Time frame · 12 months after surgery
chronic pain at 6, 9, and 12 months after surgery
Side effects
Time frame · first postoperative day
hypotension, postoperative nausea and vomiting
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)
morphine consumption
Time frame · 48 hours after surgery
Total morphine dose consumed during the second postoperative day
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
Study locations
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Tanta University Hospitals
Tanta, Gharbia Governorate, Egypt
Publications
No PMID-linked publications were present in this registry snapshot.
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