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

Sponsor
National Institute of Mental Health and Neuro Sciences, India (Other)
Overall Status
Recruiting
CT.gov ID
NCT05264012
Collaborator
(none)
450
1
24.5
18.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
450 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Incidence, Risk Factors and Impact of Significant Pain in Patients Undergoing Neurosurgery
Actual Study Start Date :
Sep 15, 2021
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Postoperative pain using Numerical Rating Scale [on days 1-3 after surgery]

    Acute postoperative pain

Secondary Outcome Measures

  1. duration of postoperative hospital stay in days [through hospital stay, an average of 10 days]

    duration of postoperative hospital stay in days

  2. postoperative sleep quality using Likert 1-5 scale [Day 2 after surgery]

    sleep quality assessment

  3. patient satisfaction using Likert scale 1-5 [Day 2 after surgery]

    patient satisfaction assessment using Likert scale 1-5

  4. Persistent postoperative pain using Numerical Rating Scale (NRS) [3 and 6 months after surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Institute of Mental Health and Neurosciences Bengaluru Karnataka India 560029

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sriganesh Kamath, Principal Investigator, National Institute of Mental Health and Neuro Sciences, India
ClinicalTrials.gov Identifier:
NCT05264012
Other Study ID Numbers:
  • 111
First Posted:
Mar 3, 2022
Last Update Posted:
Mar 3, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 3, 2022