Postoperative PainNCT05264012
Incidence, Risk Factors and Impact of Significant Pain in Patients Undergoing Neurosurgery
An observational study of Postoperative Pain and Neurosurgery, run by National Institute of Mental Health and Neuro Sciences, India at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Neurosurgery
- What is being tested?
- Neurosurgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteIndia
- Study dates
- 15 Sep 2021to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: undergoing elective cranial and non-cranial neurosurgeries
Who may be able to join
- all eligible consecutive consenting adult patients aged > 18 years with preoperative Glasgow Coma Scale (GCS) score of 15 undergoing elective craniotomies and spine surgeries
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
National Institute of Mental Health and Neurosciences
Bengaluru, Karnataka, 560029
About this study
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.
Read the 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.
- Conditions
- Postoperative Pain, Neurosurgery
- Being tested
- Neurosurgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurosurgeryProcedure or surgery
Neurosurgery
| Study group | Role | What they receive |
|---|---|---|
| Cranial neurosurgery | Patients undergoing cranial neurosurgery Receives: Procedure: Neurosurgery | |
| Non-cranial neurosurgery | Patients undergoing non-cranial neurosurgery including spine surgery Receives: Procedure: Neurosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain using Numerical Rating Scale
Acute postoperative pain
Measured: on days 1-3 after surgery
Secondary outcomes (4)
duration of postoperative hospital stay in days
duration of postoperative hospital stay in days
Measured: through hospital stay, an average of 10 days
postoperative sleep quality using Likert 1-5 scale
sleep quality assessment
Measured: Day 2 after surgery
patient satisfaction using Likert scale 1-5
patient satisfaction assessment using Likert scale 1-5
Measured: 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
Measured: 3 and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start15 Sep 2021
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sriganesh Kamath, National Institute of Mental Health and Neuro Sciences, India
- Investigators
- Sriganesh K, DM, Principal investigator, National Institute of Mental Health and Neuro Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264012
- Sponsor's protocol ID
- 111
- Status last verified
- May 2024
- First submitted
- 28 Jan 2022
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factors and Impact of Significant Pain in Patients Undergoing Neurosurgery
- ClinicalTrials.gov ID
- NCT05264012
- Acronym / sponsor ID
- 111
- Conditions
- Postoperative Pain, Neurosurgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, IndiaUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranial neurosurgery | – | Procedure: NeurosurgeryPatients undergoing cranial neurosurgery |
| Non-cranial neurosurgery | – | Procedure: NeurosurgeryPatients undergoing non-cranial neurosurgery including spine surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- undergoing elective cranial and non-cranial neurosurgeries
Key inclusion criteria (1 listed)
- all eligible consecutive consenting adult patients aged > 18 years with preoperative Glasgow Coma Scale (GCS) score of 15 undergoing elective craniotomies and spine surgeries
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurosurgeryNeurosurgery | Procedure or surgery | Cranial neurosurgery, Non-cranial neurosurgery |
Primary outcome
Postoperative pain using Numerical Rating Scale
Time frame: on days 1-3 after surgery
Acute postoperative pain
4 secondary outcomes
duration of postoperative hospital stay in days
Time frame: through hospital stay, an average of 10 days
postoperative sleep quality using Likert 1-5 scale
Time frame: Day 2 after surgery
patient satisfaction using Likert scale 1-5
Time frame: Day 2 after surgery
Persistent postoperative pain using Numerical Rating Scale (NRS)
Time frame: 3 and 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sriganesh K, DM principal investigator
National Institute of Mental Health and Neuro Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Neurosurgery, run by National Institute of Mental Health and Neuro Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain using Numerical Rating Scale (time frame: on days 1-3 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.