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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03074773
Other study ID # N-81-2016
Secondary ID
Status Completed
Phase Phase 1
First received February 24, 2017
Last updated July 18, 2017
Start date October 30, 2016
Est. completion date April 15, 2017

Study information

Verified date July 2017
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Anesthetic management for surgery of aortic coarctation needs special care due to severe pain during lateral thoracotomy incision, the intraoperative hemodynamic instability related to skin incision at lateral thoracotomy, clamping and declamping of the aorta, needs of large doses of analgesia perioperative, needs of vasodilators. Also, postoperative care of the patients after repair is very important issue. The investigators will compare the effect of para-vertebral block with bupivacaine alone or with dexamethasone on Intra and postoperative analgesia.


Description:

The patients will be divided randomly by sealed envelope into 2 equal groups. Group I (n=30) will receive paravertebral block with 0.5mg/kg bupivacaine 0.25% diluted with isotonic saline (total volume 15ml) and group II (n=30) will receive paravertebral block with 0.5mg/kg 0.25% bupivacaine and 0.1mg/kg dexamethasone.intraoperative fentanyl needs, Intra and postoperative hemodynamics and OPS pain scores will be recorded. Possible risks as hypertension will be treated by nitroglycerin infusion 0.5ug/kg/min or tachycardia (HR more than 20% than baseline) will be managed by additional doses of fentanyl 1-2ug/kg, bradycardia (20% decrease from the baseline) will be managed by atropine 0.02mg/kg. Also, the complications of paravertebral block as peridural and intravascular injection can be avoided by careful aspiration before injection and injection while visualization of the needle by U/S.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date April 15, 2017
Est. primary completion date March 30, 2017
Accepts healthy volunteers No
Gender All
Age group 4 Months to 6 Years
Eligibility Inclusion Criteria:

- 4m-6 years males and females scheduled for surgery for coarctation of the aorta

Exclusion Criteria:

- patients with associated other cardiac anomalies (e.g. VSD), patients with airway abnormality, patients with heart failure, patients with endocrine disorders, patients with history of convulsions, neurological disorder, hepatic, renal and neuromuscular diseases, coagulopathy, history of hyperthermia, infection at site of the block and family history of hypersensitivity

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone
Dexamethasone is commonly used in the perioperative period to reduce postoperative nausea and vomiting. Additionally, it has been reported to have analgesic effects. The analgesic effect of epidural or perineural dexamethasone administration is not clear. Dexamethasone might have a local anesthetic effect on nerve by direct membrane action
Device:
ultrasound
The growth of ultrasound technology and, with it, our ability to visualize the pleura and other structures in and around the paravertebral space has fueled a tremendous increased interest in performing thoracic paravertebral blocks. These blocks may be used for acute pain control, as an adjunct to general anesthesia for peri-operative pain control and, in some practices, as the primary anesthetic
Procedure:
paravertebral block
paravertebral block is an effective analgesic technique used in various types of surgery, trauma and chronic pain. it decreases postoperative pain and reduces opioid consumption which in turns improve postoperative pulmonary function hoping for early extubation.
Drug:
Bupivacaine
it is an amino amide local anesthetic drug
Other:
isotonic saline
sterile sodium chloride solution at physiological concentration (0.87%); used as diluting agent when added to local anesthetic drug

Locations

Country Name City State
Egypt Amany Hassan Saleh Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intraoperative fentanyl needs total fentanyl consumption intraoperatively 3hours
Primary postoperative analgesic requirements total narcotic consumption 24hours
Secondary the first time the analgesic required the time of narcotics need 24 hours
Secondary extubation time postoperative extubation 24 hours
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