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

Completed

• Conditions: Postoperative Pain; Neurosurgery
• Interventions: Procedure: Neurosurgery

• Registration Number: NCT05264012
• Lead Sponsor: National Institute of Mental Health and Neuro Sciences, India

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.

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 Timeline

• Study Start: 2021-09-15
• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-03-03
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cranial neurosurgery	Neurosurgery	Patients undergoing cranial neurosurgery
Non-cranial neurosurgery	Neurosurgery	Patients undergoing non-cranial neurosurgery including spine surgery

Primary Outcome Measures

Name	Time	Method
Postoperative pain using Numerical Rating Scale	on days 1-3 after surgery	Acute postoperative pain

Secondary Outcome Measures

Name	Time	Method
patient satisfaction using Likert scale 1-5	Day 2 after surgery	patient satisfaction assessment using Likert scale 1-5
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
postoperative sleep quality using Likert 1-5 scale	Day 2 after surgery	sleep quality assessment
duration of postoperative hospital stay in days	through hospital stay, an average of 10 days	duration of postoperative hospital stay in days

Trial Locations

Locations (1)

National Institute of Mental Health and Neurosciences; 🇮🇳 Bengaluru, Karnataka, India