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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05264012
• Other study ID #: 111
• Status: Recruiting
• Start date: September 15, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: March 2023
• Source: National Institute of Mental Health and Neuro Sciences, India
• Contact: Sriganesh K, DM
• Phone: 91-80-26995415
• Email: drsri23[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurosurgery
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Neurosurgery
Neurosurgery

Locations

Country	Name	City	State
India	National Institute of Mental Health and Neurosciences	Bengaluru	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health and Neuro Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain using Numerical Rating Scale	Acute postoperative pain	on days 1-3 after surgery
Secondary	duration of postoperative hospital stay in days	duration of postoperative hospital stay in days	through hospital stay, an average of 10 days
Secondary	postoperative sleep quality using Likert 1-5 scale	sleep quality assessment	Day 2 after surgery
Secondary	patient satisfaction using Likert scale 1-5	patient satisfaction assessment using Likert scale 1-5	Day 2 after surgery
Secondary	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