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

NCT ID: NCT03074773

Last Updated: 2017-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-30
• Study Completion Date: 2017-04-15

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.

Conditions

Coarctation of Aorta

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

paravertebral block with bupivacaine

this group will receive 0.5mg/kg bupivacaine 0.25% diluted with isotonic saline (total volume 15ml) paravertebral block ultrasound guided pre-emptively

Group Type: ACTIVE_COMPARATOR

ultrasound

Intervention Type: DEVICE

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

paravertebral block

Intervention Type: PROCEDURE

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.

Bupivacaine

Intervention Type: DRUG

it is an amino amide local anesthetic drug

isotonic saline

Intervention Type: OTHER

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

paravertebral block with bupivacaine and dexamethasone

this group will receive 0.5mg/kg bupivacaine 0.25% mixed to 0.1 mg/kg dexamethasone diluted with isotonic saline (total volume 15ml) paravertebral block ultrasound guided pre-emptively

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

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

ultrasound

Intervention Type: DEVICE

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

paravertebral block

Intervention Type: PROCEDURE

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.

Bupivacaine

Intervention Type: DRUG

it is an amino amide local anesthetic drug

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Bupivacaine

it is an amino amide local anesthetic drug

Intervention Type: DRUG

isotonic saline

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

Intervention Type: OTHER

Other Intervention Names

decadron; marcain; normal saline

Eligibility Criteria

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

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amany Hassan Saleh

Lecture of anethesia, Cairo university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

kasr alaini hospital

Role: STUDY_DIRECTOR

Cairo University

Locations

Amany Hassan Saleh

Cairo, , Egypt

Countries

Egypt

References

Saleh AH, Hassan PF, Elayashy M, Hamza HM, Abdelhamid MH, Madkour MA, Tawadros PZ, Omar H, Kamel MM, Zayed M, Helmy M. Role of dexamethasone in the para-vertebral block for pediatric patients undergoing aortic coarctation repair. randomized, double-blinded controlled study. BMC Anesthesiol. 2018 Nov 30;18(1):178. doi: 10.1186/s12871-018-0637-y.

Reference Type: DERIVED

PMID: 30501611 (View on PubMed)

Other Identifiers

N-81-2016

Identifier Type: -

Identifier Source: org_study_id