Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05264012
Enrollment
1000
Registered
2022-03-03
Start date
2021-09-15
Completion date
2023-10-30
Last updated
2024-05-17

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

Conditions

Neurosurgery, Postoperative Pain

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.

Interventions

PROCEDURENeurosurgery

Neurosurgery

Sponsors

National Institute of Mental Health and Neuro Sciences, India
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain using Numerical Rating Scaleon days 1-3 after surgeryAcute postoperative pain

Secondary

MeasureTime frameDescription
duration of postoperative hospital stay in daysthrough hospital stay, an average of 10 daysduration of postoperative hospital stay in days
postoperative sleep quality using Likert 1-5 scaleDay 2 after surgerysleep quality assessment
patient satisfaction using Likert scale 1-5Day 2 after surgerypatient satisfaction assessment using Likert scale 1-5
Persistent postoperative pain using Numerical Rating Scale (NRS)3 and 6 months after surgeryChronic Postoperative Pain measured using NRS (from 0 to 10, with 0 = no pain and 10 = maximal pain

Countries

India

Outcome results

None listed

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