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The Effect of Paravertebral Block With Dexamethasone on Intraoperative and Postoperative Analgesia in Children Undergoing Surgery for Coarctation of Aorta

Paravertebral Block in Coarctation of the Aorta

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03074773
Enrollment
50
Registered
2017-03-09
Start date
2016-10-30
Completion date
2017-04-15
Last updated
2017-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coarctation of Aorta

Brief 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.

Detailed 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.

Interventions

DRUGDexamethasone

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

DEVICEultrasound

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

PROCEDUREparavertebral 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.

DRUGBupivacaine

it is an amino amide local anesthetic drug

OTHERisotonic saline

sterile sodium chloride solution at physiological concentration (0.87%); used as diluting agent when added to local anesthetic drug

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Months to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative fentanyl needs3hourstotal fentanyl consumption intraoperatively
postoperative analgesic requirements24hourstotal narcotic consumption

Secondary

MeasureTime frameDescription
the first time the analgesic required24 hoursthe time of narcotics need
extubation time24 hourspostoperative extubation

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026