Postoperative PainNCT07267182
Gabapentin and Diclofenac Sodium Comparison for Post-Operative Pain Relief
A study testing Gabapentin 600mg and Diclofenac Sodium 100 MG in people with Postoperative Pain, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
Little is known about comparative efficacy of gabapentin and diclofenac sodium in managing post-operative pain. Therefore, this study was planned to compare the efficacy of gabapentin, and diclofenac sodium for post-operative pain relief in patients undergoing major abdominal surgeries. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Gabapentin 600mg and Diclofenac Sodium 100 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2022to 28 Feb 2023
- 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
- Any gender
- Aged 18-60 years
- Undergoing elective major abdominal surgery under general anesthesia
- With physical status I or II
- Who were able to comprehend and use the Visual Analogue Scale (VAS) for pain assessment
Who cannot join
- With a known allergy or contraindication to gabapentin, or diclofenac sodium
- A history of peptic ulcer disease
- A history of gastrointestinal bleeding
- Hepatic or renal dysfunction
- Pregnancy or lactation
- With neurological or psychiatric disorders affecting pain perception
Show all 9Show fewer
- Received opioids, anticonvulsants, antidepressants, or nonsteroidal anti-inflammatory drugs (NSAIDs) within 24 hours before surgery
- With uncontrolled hypertension, ischemic heart disease, or diabetes mellitus
- Those who experienced intraoperative complications necessitating a change in anesthetic plan or postoperative mechanical ventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of Gabapentin and Diclofenac Sodium for Post-Operative Pain Relief in Patients Undergoing Major Abdominal Surgeries
Little is known about comparative efficacy of gabapentin and diclofenac sodium in managing post-operative pain. Therefore, this study was planned to compare the efficacy of gabapentin, and diclofenac sodium for post-operative pain relief in patients undergoing major abdominal surgeries.
Read the detailed description
Non-steroidal anti-inflammatory drugs, opioid analgesics, and local and regional anesthesia have been used as preventive interventions, but their role in postoperative pain management remains inconclusive. Gabapentin is a relatively new drug for postoperative pain management whose side effects are well tolerated. If the findings of this study produce similar observations, it would add to the already scarce data and help patients undergoing major abdominal surgeries in the local settings in relieving postoperative pain effectively.
- Conditions
- Postoperative Pain
- Being tested
- Gabapentin 600mg, Diclofenac Sodium 100 MG
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin 600mgDrug
Patients received a single oral dose of gabapentin 600 mg one hour before surgery.
Diclofenac Sodium 100 MGDrug
Patients were given a single oral dose of diclofenac sodium 100 mg one hour before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin group | Experimental | Patients received a single oral dose of gabapentin 600 mg one hour before surgery. Receives: Drug: Gabapentin 600mg |
| Diclofenac group | Experimental | Patients were given a single oral dose of diclofenac sodium 100 mg one hour before surgery. Receives: Drug: Diclofenac Sodium 100 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
Patients were considered to have effective pain relief ("Yes") if their VAS score remained ≤3 throughout the monitoring period without requiring rescue analgesia.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Aug 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 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
- Saima Noreen, Principal investigator, Quid-e-Azam Medical College, BahawalpurAmbreen Khan, Principal investigator, Quid-e-Azam Medical College, BahawalpurQazi Anees, Principal investigator, Quid-e-Azam Medical College, Bahawalpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267182
- Sponsor's protocol ID
- DR-SAIMA-QAMC
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 5 Dec 2025
- 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 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Gabapentin and Diclofenac Sodium for Post-Operative Pain Relief in Patients Undergoing Major Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT07267182
- Acronym / sponsor ID
- DR-SAIMA-QAMC
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 5 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.
Little is known about comparative efficacy of gabapentin and diclofenac sodium in managing post-operative pain. Therefore, this study was planned to compare the efficacy of gabapentin, and diclofenac sodium for post-operative pain relief in patients undergoing major abdominal surgeries.
Detailed description
Non-steroidal anti-inflammatory drugs, opioid analgesics, and local and regional anesthesia have been used as preventive interventions, but their role in postoperative pain management remains inconclusive. Gabapentin is a relatively new drug for postoperative pain management whose side effects are well tolerated. If the findings of this study produce similar observations, it would add to the already scarce data and help patients undergoing major abdominal surgeries in the local settings in relieving postoperative pain effectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin group | Experimental | Drug: Gabapentin 600mgPatients received a single oral dose of gabapentin 600 mg one hour before surgery. |
| Diclofenac group | Experimental | Drug: Diclofenac Sodium 100 MGPatients were given a single oral dose of diclofenac sodium 100 mg one hour before surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Any gender
- Aged 18-60 years
- Undergoing elective major abdominal surgery under general anesthesia
- With physical status I or II
- Who were able to comprehend and use the Visual Analogue Scale (VAS) for pain assessment
Key exclusion criteria (9 listed)
- With a known allergy or contraindication to gabapentin, or diclofenac sodium
- A history of peptic ulcer disease
- A history of gastrointestinal bleeding
- Hepatic or renal dysfunction
- Pregnancy or lactation
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 |
|---|---|---|
| Gabapentin 600mgPatients received a single oral dose of gabapentin 600 mg one hour before surgery. | Drug | Gabapentin group |
| Diclofenac Sodium 100 MGPatients were given a single oral dose of diclofenac sodium 100 mg one hour before surgery. | Drug | Diclofenac group |
Primary outcome
Pain reduction
Time frame: 12 hours
Patients were considered to have effective pain relief ("Yes") if their VAS score remained ≤3 throughout the monitoring period without requiring rescue analgesia.
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 Dec 2025.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Saima Noreen principal investigator
Quid-e-Azam Medical College, Bahawalpur
Ambreen Khan principal investigator
Quid-e-Azam Medical College, Bahawalpur
Qazi Anees principal investigator
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 600mg and Diclofenac Sodium 100 MG in people with Postoperative Pain, 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 5 inclusion and 9 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 Dec 2025. 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 reduction (time frame: 12 hours). 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 Dec 2025.