Orthopedic SurgeryNCT07389551
Comparison of Pregabalin Versus Gabapentin as Pre-emptive Analgesic
A study testing Gabapentin and Pregabalin in people with Orthopedic Surgery, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
There are extensive gaps in the local data considering pregabalin versus gabapentin as pre-emptive analgesics in patients undergoing orthopedic surgeries under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Orthopedic Surgery
- What is being tested?
- Gabapentin and Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2025to 31 Dec 2025
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Either gender
- Aged 20-60 years
- Undergoing lower limb orthopedic surgeries under spinal anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Victoria Hospital/Qaid-e-Azam Medical College
Bahawalpur, Punjab Province, 63100
About this study
Official title: 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.
Read the 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.
- Conditions
- Orthopedic Surgery
- Being tested
- Gabapentin, Pregabalin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Patients were given a single oral dose of gabapentin 300 mg, with 30 ml of water, one hour prior to administration of spinal anesthesia.
PregabalinDrug
Patients received pregabalin 150 mg as a single oral dose, with 30 ml of water, one hour prior to administration of spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group-G | Experimental | Patients were given a single oral dose of gabapentin 300 mg, with 30 ml of water, one hour prior to administration of spinal anesthesia. Receives: Drug: Gabapentin |
| Group-P | Experimental | Patients received pregabalin 150 mg as a single oral dose, with 30 ml of water, one hour prior to administration of spinal anesthesia Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
The severity of pain was analyzed on the visual analogue scale (VAS), with a lower score labelling the effectiveness of the treatment.
Measured: 24 hours
Analgesia duration
The duration of analgesia was measured from awakening to the need of rescue analgesia, when a pain score was more than 3 on VAS.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Jul 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic SurgeryStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Muhammad Usman, Principal investigator, Bahawal Victoria Hospital/Quid-e-Azam Medical College, BahawalpurAmbreen Khan, FCPS, Study director, Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389551
- Sponsor's protocol ID
- Dr-Usman-QAMC
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pregabalin Versus Gabapentin as Pre-emptive Analgesic in Patients Undergoing Orthopedic Surgeries Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07389551
- Acronym / sponsor ID
- Dr-Usman-QAMC
- Conditions
- Orthopedic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 5 Feb 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-G | Experimental | Drug: GabapentinPatients were given a single oral dose of gabapentin 300 mg, with 30 ml of water, one hour prior to administration of spinal anesthesia. |
| Group-P | Experimental | Drug: PregabalinPatients received pregabalin 150 mg as a single oral dose, with 30 ml of water, one hour prior to administration of spinal anesthesia |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Either gender
- Aged 20-60 years
- Undergoing lower limb orthopedic surgeries under spinal anesthesia
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| GabapentinPatients were given a single oral dose of gabapentin 300 mg, with 30 ml of water, one hour prior to administration of spinal anesthesia. | Drug | Group-G |
| PregabalinPatients received pregabalin 150 mg as a single oral dose, with 30 ml of water, one hour prior to administration of spinal anesthesia. | Drug | Group-P |
Primary outcome
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.
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.
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 5 Feb 2026.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
Related trials for Orthopedic Surgery
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
Enrolling by invitationPhase 4
PPP Versus Corticosteroid for Thigh Muscle Injuries
Thigh Muscle Injury, Thigh Injury
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.
Muhammad Usman principal investigator
Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur
Ambreen Khan, FCPS study director
Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur
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 and Pregabalin in people with Orthopedic Surgery, run by Muhammad Aamir Latif at 1 site in Pakistan.
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 3 inclusion and 5 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 5 Feb 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 Pakistan. 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?
Pain severity (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 5 Feb 2026.