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To compare the effect of scalp nerve block and local anaesthetic infiltration together and with local anaesthetic infiltration alone on inflammatory response in patients undergoing elective neurosurgery.

Not yet recruiting
Conditions
Disorder of brain, unspecified, (2) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, (3) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere,
Registration Number
CTRI/2023/07/055799
Lead Sponsor
Vardhman Mahavir medical college and Safdarjung hospital
Brief Summary

This study is randomised ,comparative, prospective ,interventional study where we are comparing effect of scalp nerve block and local anaesthetic infiltration in one group and in other group only the effect of local anaesthetic infiltration alone will be studied on inflammatory response in patients undergoing elective neurosurgery under general anaesthesia by means of bio markers like c reactive protein , interleukin 6 and interleukin 10 as the primary outcome. Secondary outcome will be studied from hemodynamic stability by means of heart rate and blood pressure and comparing postoperative pain by means of visual analog scale.

In this study with this parameters , we are hypothesising that scalp nerve block and local anaesthetic infiltration together are  superior to local anaesthetic infiltration alone in controlling inflammatory response , maintaining hemodynamic stability and relieving postoperative pain.Primarily inflammatory response will be measured  by means of c recative protein , interleukin 6 and interleukin 10  first as baseline then immediately in postoperative period then at 24 hours of surgery  , secondarily hemodynamic stability measured by means of heart rate and blood pressure before anaesthesia induction, 5 minutes after skin incision, during dura opening,at the end of surgery and postoperative pain compared immediately in postoperative period and at 12 hours of surgery.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
90
Inclusion Criteria

American Society of Anaesthesiologists physical status I-II Scheduled for elective neurosurgery.

Exclusion Criteria
  • Distorted surgical anatomy of Scalp.
  • Previous craniotomy incision.
  • History of allergy to opioids or local anaesthetics.
  • Unable to understand Visual Analog Scale.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To compare scalp nerve block & local anaesthetic infiltration with local anaesthetic infiltration alone in patients undergoing elective neurosurgery by means of bio markers C-Reactive Protein, Interleukin 6 & Interleukin 10Baseline , Immediately postoperatively & at 24 hours of surgery
Secondary Outcome Measures
NameTimeMethod
To compare hemodynamic stability by means of heart rate & blood pressure ( mean arterial pressure)
To compare the postoperative pain by means of Visual Analog ScaleImmediately postoperative period & at 12 hours of surgery

Trial Locations

Locations (1)

Vardhman Mahavir medical college and Safdarjung hospital

🇮🇳

Delhi, DELHI, India

Vardhman Mahavir medical college and Safdarjung hospital
🇮🇳Delhi, DELHI, India
Priya Gond
Principal investigator
8349666527
Priyagg1993.pg@gmail.com

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