An observational study in Postoperative Pain and Neurosurgery, sponsored by National Institute of Mental Health and Neuro Sciences, India. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-17.
Sponsored by National Institute of Mental Health and Neuro Sciences, India · Observational
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.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 1,000 is above the median of 102 across 683 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →National Institute of Mental Health and Neuro Sciences, India is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
undergoing elective cranial and non-cranial neurosurgeries
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Exclusion Criteria:
Patients undergoing cranial neurosurgery
Procedure: Neurosurgery
Patients undergoing non-cranial neurosurgery including spine surgery
Procedure: Neurosurgery
Neurosurgery
Postoperative pain using Numerical Rating Scale
Acute postoperative pain
Time frame: on days 1-3 after surgery
duration of postoperative hospital stay in days
duration of postoperative hospital stay in days
Time frame: through hospital stay, an average of 10 days
postoperative sleep quality using Likert 1-5 scale
sleep quality assessment
Time frame: Day 2 after surgery
patient satisfaction using Likert scale 1-5
patient satisfaction assessment using Likert scale 1-5
Time frame: Day 2 after surgery
Persistent postoperative pain using Numerical Rating Scale (NRS)
Chronic Postoperative Pain measured using NRS (from 0 to 10, with 0 = no pain and 10 = maximal pain
Time frame: 3 and 6 months after surgery
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Sep 2021 to primary completion in Oct 2023, 25 months.
Of 391 non-industry observational studies under Pain, Postoperative, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's 25 months is above that.
Counting every sponsor, half of 395 studies reached it within 13 months; a quarter within 5 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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National Institute of Mental Health and Neuro Sciences, India