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OpenTrials
Completed

NCT Number: NCT05264012

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Neurosurgery Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute of Mental Health and Neurosciences

Bengaluru, Karnataka, 560029, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurosurgery

Procedure

Neurosurgery

Primary outcomes

  1. Postoperative pain using Numerical Rating Scale

    Time frame: on days 1-3 after surgery

    Acute postoperative pain

Secondary outcomes

  1. duration of postoperative hospital stay in days

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

    duration of postoperative hospital stay in days

  2. postoperative sleep quality using Likert 1-5 scale

    Time frame: Day 2 after surgery

    sleep quality assessment

  3. patient satisfaction using Likert scale 1-5

    Time frame: Day 2 after surgery

    patient satisfaction assessment using Likert scale 1-5

  4. Persistent postoperative pain using Numerical Rating Scale (NRS)

    Time frame: 3 and 6 months after surgery

    Chronic Postoperative Pain measured using NRS (from 0 to 10, with 0 = no pain and 10 = maximal pain

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health and Neuro Sciences, India

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2022
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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