Current partner codePEPTIDESDE
NCT06330168·Not applicable·INTERVENTIONAL

Paravertebral Calcitonin in Thoracotomy

Status

Completed

Phase

Not applicable

Enrollment

92

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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).

DRUG

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%.

Timeline

From registration to results.

  1. First posted

    Mar 26, 2024

  2. Study start

    Mar 28, 2024

  3. Primary completion

    May 14, 2025

  4. Study completion

    May 15, 2026

  5. Results posted

    Not reported

  6. Registry updated

    May 19, 2026

Outcomes

What the study measures.

Primary 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

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

1 registered sites.

Egypt. Showing up to 24 locations stored in the fast local snapshot.

Tanta University Hospitals

Tanta, Gharbia Governorate, Egypt

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Calcitonin.

Related PeptideStat pages

Put the record in context.

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