PainNCT07297888
COMPARISON OF EFFECTS OF GABAPENTIN AND CLONIDINE ON POST-OPERATIVE PAIN AND ANXIETY IN LUMBAR SPINAL SURGERY.
A study testing Gabapentin in people with Pain, run by Shri Guru Ram Rai Institute of Medical and Health Sciences at 1 site in India.
Trial summary
the investigators have tested whether gabapentin is superior to clonidine top decrease the post operative pain during spinal surgeries as a part of their thesis study. the investigators are registering this study post date as the student forgot by mistake to do so. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain
- What is being tested?
- Gabapentin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 20 Jul 2022to 20 Mar 2024
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Eligible participants were aged 18-60 years, classified as ASA physical status I or II, and scheduled for one or two-level lumbar laminectomy.
Who cannot join
- Patients with psychiatric disorders, autoimmune diseases, local infection, BMI >35, emergency procedures, tumour surgeries and the patients requiring the postoperative ventilation were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gabpentin vs Clonidine for Post Operative Pain
the investigators have tested whether gabapentin is superior to clonidine top decrease the post operative pain during spinal surgeries as a part of their thesis study. the investigators are registering this study post date as the student forgot by mistake to do so.
- Conditions
- Pain
- Being tested
- Gabapentin
- Keywords
- gabapentin, clonidine, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called clonidine
comparison of both these drugs to decrease pain
| Study group | Role | What they receive |
|---|---|---|
| clonide | Active comparator | In this group the investigators have given clonidine to the participants Receives: Drug: Gabapentin |
| placebo | Placebo comparator | in this group no active drug was given to the participants Receives: Drug: Gabapentin |
| gabapentin | Active comparator | In this group the investigators have given gabapentin to the participants Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain
Pain was assessed using the Visual Analog Scale (VAS) score ranging from 0 to 10. 10 being the worst pain and 0 being No pain
Measured: 1, 2, 4, 6, 8, 12, and 24 hours postoperatively.
Secondary outcomes (1)
anxiety
anxiety was evaluated using Hamilton Anxiety Rating Scale (HAM-A). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Measured: 1, 2, 4, 6, 8, 12, and 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start20 Jul 2022
- Primary completion20 Jan 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shri Guru Ram Rai Institute of Medical and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ADABALA VIJAY BABU, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297888
- Sponsor's protocol ID
- 14
- Status last verified
- Jan 2026
- First submitted
- 19 Nov 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we can share our research question and methodology whenever it is necessary
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabpentin vs Clonidine for Post Operative Pain
- ClinicalTrials.gov ID
- NCT07297888
- Acronym / sponsor ID
- 14
- Conditions
- Pain
- Keywords
- gabapentin, clonidine, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Shri Guru Ram Rai Institute of Medical and Health SciencesUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 22 Dec 2025 (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 investigators have tested whether gabapentin is superior to clonidine top decrease the post operative pain during spinal surgeries as a part of their thesis study. the investigators are registering this study post date as the student forgot by mistake to do so.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| clonide | Active comparator | Drug: GabapentinIn this group the investigators have given clonidine to the participants |
| placebo | Placebo comparator | Drug: Gabapentinin this group no active drug was given to the participants |
| gabapentin | Active comparator | Drug: GabapentinIn this group the investigators have given gabapentin to the participants |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Eligible participants were aged 18-60 years, classified as ASA physical status I or II, and scheduled for one or two-level lumbar laminectomy.
Key exclusion criteria (1 listed)
- Patients with psychiatric disorders, autoimmune diseases, local infection, BMI >35, emergency procedures, tumour surgeries and the patients requiring the postoperative ventilation were excluded
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 |
|---|---|---|
| GabapentinAlso: clonidinecomparison of both these drugs to decrease pain | Drug | clonide, gabapentin, placebo |
Primary outcome
post operative pain
Time frame: 1, 2, 4, 6, 8, 12, and 24 hours postoperatively.
Pain was assessed using the Visual Analog Scale (VAS) score ranging from 0 to 10. 10 being the worst pain and 0 being No pain
1 secondary outcome
anxiety
Time frame: 1, 2, 4, 6, 8, 12, and 24 hours postoperatively.
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 12 Jan 2026.
- Individual participant dataSharing planned: Yes. we can share our research question and methodology whenever it is necessary
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin in people with Pain, run by Shri Guru Ram Rai Institute of Medical and Health Sciences 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 12 Jan 2026. 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. Some participants in this study may receive a placebo. 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?
post operative pain (time frame: 1, 2, 4, 6, 8, 12, and 24 hours postoperatively.). 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 12 Jan 2026.