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

NCT ID: NCT05264012

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-15

Study Completion Date

2023-10-30

Brief Summary

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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

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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.

Conditions

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Postoperative Pain Neurosurgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cranial neurosurgery

Patients undergoing cranial neurosurgery

Neurosurgery

Intervention Type PROCEDURE

Neurosurgery

Non-cranial neurosurgery

Patients undergoing non-cranial neurosurgery including spine surgery

Neurosurgery

Intervention Type PROCEDURE

Neurosurgery

Interventions

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Neurosurgery

Neurosurgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health and Neuro Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Sriganesh Kamath

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sriganesh K, DM

Role: PRINCIPAL_INVESTIGATOR

National Institute of Mental Health and Neuro Sciences, India

Locations

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National Institute of Mental Health and Neurosciences

Bengaluru, Karnataka, India

Site Status

Countries

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India

Other Identifiers

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111

Identifier Type: -

Identifier Source: org_study_id

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