LaparoceleNCT07049380
Post-Operative Analgesic Effect of Tramadol and Nalbuphine in Smoker and Non-Smoker Patients in LC
An observational study of Laparocele, run by Superior University at 1 site in Pakistan.
Trial summary
This study aims to compare pain severity and analgesic requirements between smokers and nonsmokers following laparoscopic cholecystectomy, evaluating the efficacy of two analgesics, tramadol and nalbuphine. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Laparocele
- What is being tested?
- Comparative cross sectional
- How many people
- 132 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Mar 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study anticipates revealing significant variations in pain perception and analgesic requirements, potentially guiding tailored perioperative protocols for smokers. By addressing gaps in pain management strategies specific to smoking status, this research could enhance postoperative recovery outcomes and inform clinical practices for optimizing analgesia in diverse patient populations.
Who may be able to join
- Both Male and female patients are included.
- Adults' patients with Greater than 30 years of age
- Both Smoker and non-Smokers patients are added (Patients who are chain smoker at least 10 cigarettes per day).
Who cannot join
- Patients are excluded if they have smoking history other than cigarettes smoking like Vapes, Cigar and smokeless tobacco.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Allama Iqbal Teaching hospital
Dera Ghazi Khan, Punjab Province
About this study
Official title: Post-Operative Analgesic Effect of Tramadol and Nalbuphine in Smoker and Non-Smoker Patients Following Laparoscopic Cholecystectomy
This study aims to compare pain severity and analgesic requirements between smokers and nonsmokers following laparoscopic cholecystectomy, evaluating the efficacy of two analgesics, tramadol and nalbuphine.
Read the detailed description
The primary objectives are to estimate pain severity in smokers versus nonsmokers and identify the effect of tramadol and nalbuphine between these groups.A comparative cross-Sectional design will be employed from Allama Iqbal Teaching Hospital, DG Khan, over four months. Participants will be stratified into subgroups receiving either tramadol or nalbuphine.
- Conditions
- Laparocele
- Being tested
- Comparative cross sectional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparative cross sectionalDiagnostic test
evaluating the efficacy of two analgesics, tramadol and nalbuphine. The primary objectives are to estimate pain severity in smokers versus nonsmokers and identify the effect of tramadol and nalbuphine between these groups
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a tool used to measure pain intensity, mood, or other subjective experiences. It typically involves a 10 cm (100mm) line with descriptive anchors at each end, such as "no pain" and "worst pain imaginable
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start17 Mar 2025
- Primary completion1 Aug 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoceleStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049380
- Sponsor's protocol ID
- MSAHSW/Batch-Fall23/910
- Status last verified
- Jun 2025
- First submitted
- 25 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Analgesic Effect of Tramadol and Nalbuphine in Smoker and Non-Smoker Patients Following Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07049380
- Acronym / sponsor ID
- MSAHSW/Batch-Fall23/910
- Conditions
- Laparocele
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 3 Jul 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.
This study aims to compare pain severity and analgesic requirements between smokers and nonsmokers following laparoscopic cholecystectomy, evaluating the efficacy of two analgesics, tramadol and nalbuphine.
Detailed description
The primary objectives are to estimate pain severity in smokers versus nonsmokers and identify the effect of tramadol and nalbuphine between these groups.A comparative cross-Sectional design will be employed from Allama Iqbal Teaching Hospital, DG Khan, over four months. Participants will be stratified into subgroups receiving either tramadol or nalbuphine.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study anticipates revealing significant variations in pain perception and analgesic requirements, potentially guiding tailored perioperative protocols for smokers. By addressing gaps in pain management strategies specific to smoking status, this research could enhance postoperative recovery outcomes and inform clinical practices for optimizing analgesia in diverse patient populations.
Key inclusion criteria (3 listed)
- Both Male and female patients are included.
- Adults' patients with Greater than 30 years of age
- Both Smoker and non-Smokers patients are added (Patients who are chain smoker at least 10 cigarettes per day).
Key exclusion criteria (1 listed)
- Patients are excluded if they have smoking history other than cigarettes smoking like Vapes, Cigar and smokeless tobacco.
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 |
|---|---|---|
| Comparative cross sectionalevaluating the efficacy of two analgesics, tramadol and nalbuphine. The primary objectives are to estimate pain severity in smokers versus nonsmokers and identify the effect of tramadol and nalbuphine between these groups | Diagnostic test | – |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 12 Months
The Visual Analog Scale (VAS) is a tool used to measure pain intensity, mood, or other subjective experiences. It typically involves a 10 cm (100mm) line with descriptive anchors at each end, such as "no pain" and "worst pain imaginable
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Laparocele
Active, not recruitingObservational study
Evaluation of Hemodynamic Changes Using Different IAP for LC Under General Anesthesia
Laparocele
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparocele, run by Superior University 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 1 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: under way, not looking for participants, as of the sponsor's last update on 3 Jul 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?
This study is still under way. Results are not available in the source record yet.
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?
Visual Analog Scale (VAS) (time frame: 12 Months). 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 3 Jul 2025.