Clinical trial NCT05264012: Incidence, Risk Factors and Impact of Significant Pain in Patients Undergoing Neurosurgery
Official title: Incidence, Risk Factors and Impact of Significant Pain in Patients Undergoing Neurosurgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Neurosurgery
Lead sponsor: National Institute of Mental Health and Neuro Sciences, India
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: undergoing elective cranial and non-cranial neurosurgeries

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.

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

Primary outcomes:
measure: Postoperative pain using Numerical Rating Scale
timeFrame: on days 1-3 after surgery
Secondary outcomes:
measure: duration of postoperative hospital stay in days
timeFrame: through hospital stay, an average of 10 days
measure: postoperative sleep quality using Likert 1-5 scale
timeFrame: Day 2 after surgery
measure: patient satisfaction using Likert scale 1-5
timeFrame: Day 2 after surgery
measure: Persistent postoperative pain using Numerical Rating Scale (NRS)
timeFrame: 3 and 6 months after surgery
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: National Institute of Mental Health and Neurosciences
state: Karnataka
Study officials:
affiliation: National Institute of Mental Health and Neuro Sciences, India
name: Sriganesh K, DM
role: PRINCIPAL_INVESTIGATOR
References: