- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07297888
COMPARISON OF EFFECTS OF GABAPENTIN AND CLONIDINE ON POST-OPERATIVE PAIN AND ANXIETY IN LUMBAR SPINAL SURGERY.
January 8, 2026 updated by: ADABALA VIJAY BABU, Shri Guru Ram Rai Institute of Medical and Health Sciences
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Uttarakhand
-
Dehradun, Uttarakhand, India, 246001
- Adabala Vijay Babu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Eligible participants were aged 18-60 years, classified as ASA physical status I or II, and scheduled for one or two-level lumbar laminectomy.
Exclusion Criteria:
- Patients with psychiatric disorders, autoimmune diseases, local infection, BMI >35, emergency procedures, tumour surgeries and the patients requiring the postoperative ventilation were excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: clonide
In this group the investigators have given clonidine to the participants
|
comparison of both these drugs to decrease pain
Other Names:
|
|
Placebo Comparator: placebo
in this group no active drug was given to the participants
|
comparison of both these drugs to decrease pain
Other Names:
|
|
Active Comparator: gabapentin
In this group the investigators have given gabapentin to the participants
|
comparison of both these drugs to decrease pain
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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, 2, 4, 6, 8, 12, and 24 hours postoperatively.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anxiety
Time Frame: 1, 2, 4, 6, 8, 12, and 24 hours postoperatively.
|
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.
|
1, 2, 4, 6, 8, 12, and 24 hours postoperatively.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 20, 2022
Primary Completion (Actual)
January 20, 2024
Study Completion (Actual)
March 20, 2024
Study Registration Dates
First Submitted
November 19, 2025
First Submitted That Met QC Criteria
December 17, 2025
First Posted (Estimated)
December 22, 2025
Study Record Updates
Last Update Posted (Estimated)
January 12, 2026
Last Update Submitted That Met QC Criteria
January 8, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Amino Acids, Peptides, and Proteins
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Azoles
- Hydrocarbons
- Cyclohexanes
- Cycloparaffins
- Hydrocarbons, Alicyclic
- Hydrocarbons, Cyclic
- Acids, Acyclic
- Carboxylic Acids
- Imidazoles
- Amines
- Amino Acids
- gamma-Aminobutyric Acid
- Aminobutyrates
- Butyrates
- Acids, Carbocyclic
- Cyclohexanecarboxylic Acids
- Imidazolines
- Gabapentin
- Clonidine
Other Study ID Numbers
- 14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
we can share our research question and methodology whenever it is necessary
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
Boston Scientific CorporationRecruitingLow Back Pain | Chronic Pain | Chronic Low-back Pain | Leg Pain | Intractable Pain | Chronic Leg PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Qi's ClinicNot yet recruitingNon-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
noiVita SrlsUniversity of Eastern PiedmontCompletedCervical Pain | Pain Management | Lumbar Pain | Muscular | Chronic Pain (Back / Neck)Italy
-
Chinese University of Hong KongNot yet recruitingPain, Acute | Chronic Post Operative Pain | Pain, ChronicHong Kong
-
University of SaskatchewanRoyal University Hospital FoundationCompletedPain | Pain, Acute | Pain, Chronic | Pain, IntractableCanada
-
Kyowa Kirin Co., Ltd.Completed
Clinical Trials on Gabapentin
-
University Hospital, GhentAmsterdam UMC, location VUmc; University GhentCompletedEpilepsy and Neuropathic PainBelgium
-
Samuel Lunenfeld Research Institute, Mount Sinai...Completed
-
Viatris Specialty LLCCompletedAbuse PotentialUnited States
-
Mayo ClinicCompleted
-
University of KarachiCenter for Bioequivalence Studies and Clinical Research; Merck Pvt. Ltd, PakistanCompletedHealthy Volunteers | Bioequivalence StudyPakistan
-
Indiana UniversityCompletedPostoperative PainUnited States
-
Ain Shams UniversityNot yet recruiting
-
Celgene CorporationCompletedBreast Neoplasms | Metastases, NeoplasmUnited States
-
Celgene CorporationCompletedNeoplasms | Metastases, NeoplasmUnited States
-
XenoPort, Inc.Completed