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Clinical Trials/NCT05264012
NCT05264012
Completed
Not Applicable

Incidence, Risk Factors and Impact of Significant Pain in Patients Undergoing Neurosurgery

National Institute of Mental Health and Neuro Sciences, India1 site in 1 country1,000 target enrollmentSeptember 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
National Institute of Mental Health and Neuro Sciences, India
Enrollment
1000
Locations
1
Primary Endpoint
Postoperative pain using Numerical Rating Scale
Status
Completed
Last Updated
last year

Overview

Brief Summary

The proposed study intends to evaluate incidence of postoperative pain after neurosurgery. This study is likely to help in understanding of the magnitude of this problem in our country and inform about possible predictors which will help institute pre-emptive interventions to mitigate modifiable risk factors of pain after neurosurgery.

Detailed Description

Data regarding potential risk factors for postoperative pain will be collected. Preoperative factors (preoperative pain, anxiety or depression, perception about surgery, age, gender, socio-economic status, educational level, domicile location, obesity, surgical site \[infratentorial or supratentorial or cervical, thoracic or lumbar\], use of steroids and analgesics), and intraoperative factors (scalp/ESP/caudal block, incision site infiltration, dose of analgesics such as opioids, paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs), co-analgesics such as nitrous oxide, gabapentionoids, dexmedetomidine, magnesium or lignocaine infusion, anti-epileptics, steroids, minimum alveolar concentration (MAC) of inhalational anesthetics, and duration of surgery and anesthesia) that are likely to be associated with occurrence of postoperative pain will be explored along with relationship between acute and persistent postoperative pain and between intraoperative nociception and postoperative pain.

Registry
clinicaltrials.gov
Start Date
September 15, 2021
End Date
October 30, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
National Institute of Mental Health and Neuro Sciences, India
Responsible Party
Principal Investigator
Principal Investigator

Sriganesh Kamath

Principal Investigator

National Institute of Mental Health and Neuro Sciences, India

Eligibility Criteria

Inclusion Criteria

  • all eligible consecutive consenting adult patients aged \> 18 years with preoperative Glasgow Coma Scale (GCS) score of 15 undergoing elective craniotomies and spine surgeries

Exclusion Criteria

  • children, patients with GCS \< 15, patients not extubated within 2 hours of end of anesthesia and those who not able to respond to our questions on outcomes

Outcomes

Primary Outcomes

Postoperative pain using Numerical Rating Scale

Time Frame: on days 1-3 after surgery

Acute postoperative pain

Secondary Outcomes

  • patient satisfaction using Likert scale 1-5(Day 2 after surgery)
  • Persistent postoperative pain using Numerical Rating Scale (NRS)(3 and 6 months after surgery)
  • postoperative sleep quality using Likert 1-5 scale(Day 2 after surgery)
  • duration of postoperative hospital stay in days(through hospital stay, an average of 10 days)

Study Sites (1)

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