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CompletedNCT05264012Updated May 17, 2024

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

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Postoperative Pain
  • Neurosurgery

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

undergoing elective cranial and non-cranial neurosurgeries

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (actual)
Patient registry
No

Groups and cohorts

  • Cranial neurosurgery

    Patients undergoing cranial neurosurgery

    Procedure: Neurosurgery

  • Non-cranial neurosurgery

    Patients undergoing non-cranial neurosurgery including spine surgery

    Procedure: Neurosurgery

Interventions

  • ProcedureNeurosurgery

    Neurosurgery

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What researchers measure

Primary outcomes

  1. Postoperative pain using Numerical Rating Scale

    Acute postoperative pain

    Time frame: on days 1-3 after surgery

Secondary outcomes

  1. duration of postoperative hospital stay in days

    duration of postoperative hospital stay in days

    Time frame: through hospital stay, an average of 10 days

  2. postoperative sleep quality using Likert 1-5 scale

    sleep quality assessment

    Time frame: Day 2 after surgery

  3. patient satisfaction using Likert scale 1-5

    patient satisfaction assessment using Likert scale 1-5

    Time frame: Day 2 after surgery

  4. 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

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Study locations

1 site
  • National Institute of Mental Health and Neurosciences
    Bengaluru, Karnataka 560029, India
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT05264012
Lead sponsor
National Institute of Mental Health and Neuro Sciences, India
Responsible party
Sriganesh Kamath (Principal Investigator, National Institute of Mental Health and Neuro Sciences, India) — Principal investigator
First posted
Mar 3, 2022
Start date
Sep 15, 2021
Primary completion
Oct 30, 2023
Completion
Oct 30, 2023
Last update
May 17, 2024

Study contacts

Sriganesh K, DM
principal investigator · National Institute of Mental Health and Neuro Sciences, India

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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