Clinical trial NCT06330168: Paravertebral Calcitonin in Thoracotomy
Official title: The Analgesic Value of Paravertebral Calcitonin in Patients Undergoing Thoracotomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Calcitonin
Paravertebral
Thoracotomy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: morphine consumption
timeFrame: from the end of surgery until the end of the first postoperative day
measure: Incidence of chronic pain at 3 months after surgery
timeFrame: 3 months after surgery
Secondary outcomes:
measure: numerical rating scale scores
timeFrame: from arrival to the post-anesthesia care unit until 48 hour after surgery.
measure: incidence of chronic pain
timeFrame: 6 months after surgery
measure: Side effects
timeFrame: first postoperative day
measure: Intensity of chronic pain
timeFrame: 3 months and 6 months after surgery
measure: morphine consumption
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Gharbiya
Study officials:
References: