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

NCT05264012 | Completed

• 1 other identifier: 111
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Neurosurgery

Outcome Measures

Primary Outcomes (1)

• Postoperative pain using Numerical Rating Scale

  Acute postoperative pain

  on days 1-3 after surgery

Secondary Outcomes (4)

• duration of postoperative hospital stay in days

  through hospital stay, an average of 10 days

• postoperative sleep quality using Likert 1-5 scale

  Day 2 after surgery

• patient satisfaction using Likert scale 1-5

  Day 2 after surgery

• Persistent postoperative pain using Numerical Rating Scale (NRS)

  3 and 6 months after surgery

Study Arms (2)

Cranial neurosurgery

Patients undergoing cranial neurosurgery

Procedure: Neurosurgery

Non-cranial neurosurgery

Patients undergoing non-cranial neurosurgery including spine surgery

Procedure: Neurosurgery

Interventions

Neurosurgery PROCEDURE

Neurosurgery

Cranial neurosurgery; Non-cranial neurosurgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

undergoing elective cranial and non-cranial neurosurgeries

You may qualify if:

• all eligible consecutive consenting adult patients aged \> 18 years with preoperative Glasgow Coma Scale (GCS) score of 15 undergoing elective craniotomies and spine surgeries

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Mental Health and Neuro Sciences, India: lead

Study Sites (1)

National Institute of Mental Health and Neurosciences

Bengaluru, Karnataka, 560029, India

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Neurosurgical Procedures

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Sriganesh K, DM

  National Institute of Mental Health and Neuro Sciences, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: March 3, 2022
• Study Start: September 15, 2021
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

IN (1)