- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07389551
Comparison of Pregabalin Versus Gabapentin as Pre-emptive Analgesic
January 29, 2026 updated by: Muhammad Aamir Latif
Comparison of Pregabalin Versus Gabapentin as Pre-emptive Analgesic in Patients Undergoing Orthopedic Surgeries Under Spinal Anesthesia
There are extensive gaps in the local data considering pregabalin versus gabapentin as pre-emptive analgesics in patients undergoing orthopedic surgeries under spinal anesthesia.
Therefore, the current study was planned with the objective of comparing pregabalin versus gabapentin as pre-emptive analgesics in patients undergoing orthopedic surgeries under spinal anesthesia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Since postoperative pain in orthopedic surgery, whether neuropathic or nociceptive, presents a significant challenge for both surgeons and patients, knowing the more effective gabapentinoid as a pre-emptive analgesic would help clinicians to offer prolonged timing of first rescue analgesia and less opioid consumption.
Study Type
Interventional
Enrollment (Actual)
142
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
-
-
Punjab Province
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Bahawalpur, Punjab Province, Pakistan, 63100
- Victoria Hospital/Qaid-e-Azam Medical College
-
-
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:
- Either gender
- Aged 20-60 years
- Undergoing lower limb orthopedic surgeries under spinal anesthesia
Exclusion Criteria:
- Patients with a previous history of spine interventions, including surgery or injections (transforaminal, epidural, or facetal) for pain relief
- Patients under any sort of pain modulation therapy, like transcutaneous electrical nerve stimulation
- Patients had a long-term history of any analgesia use
- Those with psychiatric disorders, alcohol/drug dependence, hepatic, renal, cardiac, or pulmonary abnormalities,
- With a history of allergies to gabapentinoids
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group-G
Patients were given a single oral dose of gabapentin 300 mg, with 30 ml of water, one hour prior to administration of spinal anesthesia.
|
Patients were given a single oral dose of gabapentin 300 mg, with 30 ml of water, one hour prior to administration of spinal anesthesia.
|
|
Experimental: Group-P
Patients received pregabalin 150 mg as a single oral dose, with 30 ml of water, one hour prior to administration of spinal anesthesia
|
Patients received pregabalin 150 mg as a single oral dose, with 30 ml of water, one hour prior to administration of spinal anesthesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain severity
Time Frame: 24 hours
|
The severity of pain was analyzed on the visual analogue scale (VAS), with a lower score labelling the effectiveness of the treatment.
|
24 hours
|
|
Analgesia duration
Time Frame: 24 hours
|
The duration of analgesia was measured from awakening to the need of rescue analgesia, when a pain score was more than 3 on VAS.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Muhammad Usman, Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur
- Study Director: Ambreen Khan, FCPS, Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur
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 1, 2025
Primary Completion (Actual)
December 31, 2025
Study Completion (Actual)
December 31, 2025
Study Registration Dates
First Submitted
January 29, 2026
First Submitted That Met QC Criteria
January 29, 2026
First Posted (Actual)
February 5, 2026
Study Record Updates
Last Update Posted (Actual)
February 5, 2026
Last Update Submitted That Met QC Criteria
January 29, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Amino Acids, Peptides, and Proteins
- Organic Chemicals
- Hydrocarbons
- Cyclohexanes
- Cycloparaffins
- Hydrocarbons, Alicyclic
- Hydrocarbons, Cyclic
- Acids, Acyclic
- Carboxylic Acids
- Amines
- Amino Acids
- gamma-Aminobutyric Acid
- Aminobutyrates
- Butyrates
- Acids, Carbocyclic
- Cyclohexanecarboxylic Acids
- Gabapentin
- Pregabalin
Other Study ID Numbers
- Dr-Usman-QAMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data can be shared on a reasonable request.
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.
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