Pain ManagementNCT06594224
Comparison of IV Nalbuphine Versus Ibuprofen for Postoperative Pain Control in Cesarean Section
A study testing Ibuprofen and Nalbuphine in people with Pain Management, run by Muhammad Aamir Latif at 2 sites in Pakistan.
Trial summary
The local data is insufficient to directly compare IV nalbuphine versus ibuprofen among people in this region. The findings of this study would add to the existing data and would be helpful for health providers to opt for a better option for postoperative pain relief following a cesarean section under general… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pain Management
- What is being tested?
- Ibuprofen and Nalbuphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Mar 2024to 31 Aug 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Parturient females
- Aged between 18-45 years
- Gestational age above 32 weeks
- ASA class I to II
- Anticipated hospital stay for at least 24 hours
Who cannot join
- Known allergy to the drugs being evaluated in this study
- Renal and/or hepatic impairment (as per medical record)
- History of bronchial asthma or history or risk of intracranial hemorrhage (as per medical record)
- Low platelets count (\<70000) or with bleeding diathesis
- BMI above 30 kg/m2
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Nishtar Hospital
Multan, Punjab Province, 66000
Nishtar Medical University
Multan, Punjab Province, 66000
About this study
The local data is insufficient to directly compare IV nalbuphine versus ibuprofen among people in this region. The findings of this study would add to the existing data and would be helpful for health providers to opt for a better option for postoperative pain relief following a cesarean section under general anesthesia.
- Conditions
- Pain Management
- Being tested
- Ibuprofen, Nalbuphine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Patients were given 800 mg Ibuprofen in 200 cc normal saline intravenously at the time of arrival in the ward.
NalbuphineDrug
Patients received 20 mg nalbuphine in 200 cc normal saline IV at the time of arrival in the ward.
| Study group | Role | What they receive |
|---|---|---|
| IV Ibuprofen Group | Experimental | Females in this group (n=40) were given 800 mg Ibuprofen in 200 cc normal saline intravenously at the time of arrival in the ward Receives: Drug: Ibuprofen |
| IV Nalbuphine | Experimental | Patients in this group received 20 mg nalbuphine in 200 cc normal saline IV at the time of arrival in the ward. Receives: Drug: Nalbuphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in pain control
Outcome was noted in the form of VAS pain scores. Scores from 1 to 3 were labeled as mild pain, 4 to 6 as moderate pain, and 7 to 10 as severe pain.
Measured: At 1 hour, 3 hours, and 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Mar 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies 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
- 80 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
- Mehnaz Khakwani, FCPS, Principal investigator, Department of Obstetric and Gynecology Nishtar Medical University, MultanHajra Sultana, FCPS, Principal investigator, Department of Obstetric and Gynecology Nishtar Medical University, Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594224
- Sponsor's protocol ID
- NishterMultan-1
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared with other researchers on a reasonable request
Publications
Khakwani M, Parveen R, Sultana H. Comparison of IV Nalbuphine versus ibuprofen for Postoperative Pain control in cesarean section. Pak J Med Sci. 2025 Sep;41(9):2612-2617. doi: 10.12669/pjms.41.9.11016.
PubMed 41070313
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of IV Nalbuphine Versus Ibuprofen for Postoperative Pain Control in Cesarean Section
- ClinicalTrials.gov ID
- NCT06594224
- Acronym / sponsor ID
- NishterMultan-1
- Conditions
- Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 19 Sep 2024 (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 local data is insufficient to directly compare IV nalbuphine versus ibuprofen among people in this region. The findings of this study would add to the existing data and would be helpful for health providers to opt for a better option for postoperative pain relief following a cesarean section under general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Ibuprofen Group | Experimental | Drug: IbuprofenFemales in this group (n=40) were given 800 mg Ibuprofen in 200 cc normal saline intravenously at the time of arrival in the ward |
| IV Nalbuphine | Experimental | Drug: NalbuphinePatients in this group received 20 mg nalbuphine in 200 cc normal saline IV at the time of arrival in the ward. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Parturient females
- Aged between 18-45 years
- Gestational age above 32 weeks
- ASA class I to II
- Anticipated hospital stay for at least 24 hours
Key exclusion criteria (5 listed)
- Known allergy to the drugs being evaluated in this study
- Renal and/or hepatic impairment (as per medical record)
- History of bronchial asthma or history or risk of intracranial hemorrhage (as per medical record)
- Low platelets count (\<70000) or with bleeding diathesis
- BMI above 30 kg/m2
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 |
|---|---|---|
| IbuprofenPatients were given 800 mg Ibuprofen in 200 cc normal saline intravenously at the time of arrival in the ward. | Drug | IV Ibuprofen Group |
| NalbuphinePatients received 20 mg nalbuphine in 200 cc normal saline IV at the time of arrival in the ward. | Drug | IV Nalbuphine |
Primary outcome
Efficacy in pain control
Time frame: At 1 hour, 3 hours, and 6 hours.
Outcome was noted in the form of VAS pain scores. Scores from 1 to 3 were labeled as mild pain, 4 to 6 as moderate pain, and 7 to 10 as severe pain.
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 19 Sep 2024.
- Derived from this study: PubMed 41070313Khakwani M, Parveen R, Sultana H. Comparison of IV Nalbuphine versus ibuprofen for Postoperative Pain control in cesarean section. Pak J Med Sci. 2025 Sep;41(9):2612-2617. doi: 10.12669/pjms.41.9.11016.
- Individual participant dataSharing planned: No. Data can be shared with other researchers on a reasonable request
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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.
Mehnaz Khakwani, FCPS principal investigator
Department of Obstetric and Gynecology Nishtar Medical University, Multan
Hajra Sultana, FCPS principal investigator
Department of Obstetric and Gynecology Nishtar Medical University, Multan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen and Nalbuphine in people with Pain Management, run by Muhammad Aamir Latif at 2 sites 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 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Efficacy in pain control (time frame: At 1 hour, 3 hours, and 6 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06594224, which also lists 1 linked publication.
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 19 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.