Role of dexamethasone in regional pain relief in children undergoing kidney surgery.

Phase 3

Not yet recruiting

Conditions: healthy ASA 1 OR 2

Registration Number: CTRI/2018/06/014429

Lead Sponsor: FLUID research grant

Brief Summary: **BACKGROUND:**Dexamethasone have been shown to potentiate the action of local anesthetic in peripheral nerve block in various study conducted in adult patients. In this proposed study we would like to evaluate the effect of intravenous and perineural preservative-free dexamethasone as an adjuvant on the duration of paravertebral block with ropivacaine in children undergoing open -pyeloplasty.

**Aim:**The aim of this study is to compare the analgesic and adverse effects of dexamethasone as an adjuvant in paravertebral block in children undergoing open pyeloplasty.

**Objective:**

**Primary Objective:**The primary objective of this study will be to evaluate and compare the efficacy and duration of intra-venous verses perineural preservative-free dexamethasone when added to paravertebral block with ropivacaine in post-operative analgesia in children.

**Secondary Objective**: The secondary objective of the study is to evaluate the adverse events and pain score of both intra-venous and paravertebral dexamethasone group

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 140

Inclusion Criteria

All children between 2 and 14 years posted for open pyeloplasty consented/ assented for study.

Exclusion Criteria

1.Patients with cutaneous infection at the site of needle puncture, 2.Pathology in the paravertebral space, 3.Allergy to local anesthetic drugs, 4.Obesity, 5.Coagulopathy, 6.Creatinine clearance less than 90 ml//min/1.73m2 7.Kyphoscoliosis 8.Diabetes mellitus 9.Malignancy 10.Psychiatric disorder 11.Immunocompromised child (HIV, already on dexamethasone, inflammatory disease).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
comparing the efficacy and duration of the paravertebral block	Efficacy of the block will be assessed by calculating total analgesics requirement in both arms in morphine equivalents for 48 hours or till discharge from ward. \| Duration of the block will be assessed by calculating the time take from block administration to first rescue analgesia administered in minutes.

Secondary Outcome Measures

Name	Time	Method
incidence of adverse events such as vascular puncture (blood aspirate),Abandoned block (unable to place),Failed block (completed but not successful),Respiratory: pneumothorax, respiratory depression, apnea other,Cardiovascular: arrhythmia, hypotension, cardiac arrest, other	within 48 hours from time of block administration or discharge from ward
Incidence and severity scores of pains in recovery and surgical ward.FLACC (Face, Legs, Activity, Cry, Consolability) score for preverbal children and VAS(Visual Analogue Scale) score for verbal children.	In the recovery ward pain score and rescue analgesia is needed will be noted, at time of arrival and every one hourly till discharge to the surgical ward.

Trial Locations

Locations (1): Christian Medical College , Vellore
🇮🇳
Vellore, TAMIL NADU, India
Christian Medical College , Vellore
🇮🇳Vellore, TAMIL NADU, India
David Vincent
Principal investigator
anaesthesia@cmcvellore.ac.in