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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Neurosurgery
• Intervention / Treatment: Procedure: Neurosurgery

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.

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

• Study Contact: Name: Sriganesh K, DM; Phone Number: 91-80-26995415; Email: drsri23@gmail.com

Study Locations

• India
  • Karnataka
    • Bengaluru, Karnataka, India, 560029
      • Recruiting
      • National Institute of Mental Health and Neurosciences
      • Contact: Sriganesh K

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

undergoing elective cranial and non-cranial neurosurgeries

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cranial neurosurgery; Patients undergoing cranial neurosurgery	Procedure: Neurosurgery; Neurosurgery
Non-cranial neurosurgery; Patients undergoing non-cranial neurosurgery including spine surgery	Procedure: Neurosurgery; Neurosurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain using Numerical Rating Scale	Acute postoperative pain	on days 1-3 after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of postoperative hospital stay in days	duration of postoperative hospital stay in days	through hospital stay, an average of 10 days
postoperative sleep quality using Likert 1-5 scale	sleep quality assessment	Day 2 after surgery
patient satisfaction using Likert scale 1-5	patient satisfaction assessment using Likert scale 1-5	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	3 and 6 months after surgery

Collaborators and Investigators

• Sponsor: National Institute of Mental Health and Neuro Sciences, India
• Investigators: Principal Investigator: Sriganesh K, DM, National Institute of Mental Health and Neuro Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No