Postoperative PainPhase 4NCT01564680
Lornoxicam vs. Paracetamol After Lower Abdominal Surgery
A Phase 4 study testing Paracetamol and Lornoxicam in people with Postoperative Pain, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial summary
Background: The aim of this prospective, randomized, double-blind study is to determine the most effective supplemental analgesic, paracetamol or lornoxicam for postoperative pain relief after lower abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Paracetamol and Lornoxicam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Mar 2009to Mar 2011
- Phase
- Phase 4
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lower abdominal surgery
Who cannot join
- body weight more than 150% of their ideal body weight
- history of significant cardiac, pulmonary, renal, hepatic or hematological disease; chronic drug or alcohol abuse; hypersensitivity to any of the studied drugs; bronchial asthma; gastritis or peptic ulcer; and pregnancy
- patients who received any analgesic drug a day before surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Lornoxicam is More Effective Than Paracetamol as a Supplemental Analgesic After Lower Abdominal Surgery; A Randomized Controlled Trial
Background: The aim of this prospective, randomized, double-blind study is to determine the most effective supplemental analgesic, paracetamol or lornoxicam for postoperative pain relief after lower abdominal surgery.
Methods: Sixty patients scheduled for lower abdominal surgery under general anesthesia were randomly allocated to receive either isotonic saline (Control group), intravenous paracetamol 1 g every 6 h (Paracetamol group) or lornoxicam 16 mg then 8 mg after 12 h (Lornoxicam group). Additionally pain was treated postoperatively using morphine patient-controlled analgesia. Postoperative pain scores measured by the verbal pain score (VPS), morphine consumption and the incidence of side effects were measured at 1, 2, 4, 8, 12 and 24 hours postoperatively.
- Conditions
- Postoperative Pain
- Being tested
- placebo, Paracetamol, Lornoxicam
- Keywords
- Lower abdominal surgery, Paracetamol, Lornoxicam, Morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
Also called 0.9 N sodium chloride
normal saline
ParacetamolDrug
Also called perfalgan
IV paracetamol infusion
LornoxicamDrug
Also called xefo
16 mg at skin closure and 8 mg 12 hours postoperative
| Study group | Role | What they receive |
|---|---|---|
| Lornoxicam | Experimental | Lornoxicam 16 mg will be given at skin closure and 8 mg will be given 12 hours postoperatively Receives: Drug: Lornoxicam |
| Control | Placebo comparator | Patients will receive normal saline at skin closure, at 6, 12, 18 hours postoperatively. Receives: Other: placebo |
| Paracetamol | Experimental | 1 gm of paracetamol will be given at skin closure, 6, 12, 18 hours postoperatively Receives: Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain scores measured by the verbal pain score (VPS)1, 2, 4, 8, 12 and 24 hours postoperatively.
Measured: 24 hours
Secondary outcomes (2)
Morphine consumption
pain was treated postoperatively using morphine patient-controlled analgesia. Morphine consumption was measured at 1, 2, 4, 8, 12 and 24 hours postoperatively
Measured: 24 hours
Incidence of side-effects
incidence of side effects was measured at 1,2,4,8, 12, 24 hr postoperatively.
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 posted28 Mar 2012 (estimated)
- Study startMar 2009
- Primary completionMar 2011
- Study completionMar 2011
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hany A Mowafi, MD, Principal investigator, UD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564680
- Sponsor's protocol ID
- #201021
- Status last verified
- Mar 2012
- First submitted
- 26 Mar 2012
- Last updated
- 28 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mowafi HA, Elmakarim EA, Ismail S, Al-Mahdy M, El-Saflan AE, Elsaid AS. Intravenous lornoxicam is more effective than paracetamol as a supplemental analgesic after lower abdominal surgery: a randomized controlled trial. World J Surg. 2012 Sep;36(9):2039-44. doi: 10.1007/s00268-012-1649-2.
PubMed 22584689
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Lornoxicam is More Effective Than Paracetamol as a Supplemental Analgesic After Lower Abdominal Surgery; A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01564680
- Acronym / sponsor ID
- #201021
- Conditions
- Postoperative Pain
- Keywords
- Lower abdominal surgery, Paracetamol, Lornoxicam, Morphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 28 Mar 2012 (estimated)
- 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.
Background: The aim of this prospective, randomized, double-blind study is to determine the most effective supplemental analgesic, paracetamol or lornoxicam for postoperative pain relief after lower abdominal surgery.
Methods: Sixty patients scheduled for lower abdominal surgery under general anesthesia were randomly allocated to receive either isotonic saline (Control group), intravenous paracetamol 1 g every 6 h (Paracetamol group) or lornoxicam 16 mg then 8 mg after 12 h (Lornoxicam group). Additionally pain was treated postoperatively using morphine patient-controlled analgesia. Postoperative pain scores measured by the verbal pain score (VPS), morphine consumption and the incidence of side effects were measured at 1, 2, 4, 8, 12 and 24 hours postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lornoxicam | Experimental | Drug: LornoxicamLornoxicam 16 mg will be given at skin closure and 8 mg will be given 12 hours postoperatively |
| Control | Placebo comparator | Other: placeboPatients will receive normal saline at skin closure, at 6, 12, 18 hours postoperatively. |
| Paracetamol | Experimental | Drug: Paracetamol1 gm of paracetamol will be given at skin closure, 6, 12, 18 hours postoperatively |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- lower abdominal surgery
Key exclusion criteria (3 listed)
- body weight more than 150% of their ideal body weight
- history of significant cardiac, pulmonary, renal, hepatic or hematological disease; chronic drug or alcohol abuse; hypersensitivity to any of the studied drugs; bronchial asthma; gastritis or peptic ulcer; and pregnancy
- patients who received any analgesic drug a day before surgery
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 |
|---|---|---|
| placeboAlso: 0.9 N sodium chloridenormal saline | Other | Control |
| ParacetamolAlso: perfalganIV paracetamol infusion | Drug | Paracetamol |
| LornoxicamAlso: xefo16 mg at skin closure and 8 mg 12 hours postoperative | Drug | Lornoxicam |
Primary outcome
Postoperative pain
Time frame: 24 hours
Postoperative pain scores measured by the verbal pain score (VPS)1, 2, 4, 8, 12 and 24 hours postoperatively.
2 secondary outcomes
Morphine consumption
Time frame: 24 hours
Incidence of side-effects
Time frame: 24 hours
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 28 Mar 2012.
- Derived from this study: PubMed 22584689Mowafi HA, Elmakarim EA, Ismail S, Al-Mahdy M, El-Saflan AE, Elsaid AS. Intravenous lornoxicam is more effective than paracetamol as a supplemental analgesic after lower abdominal surgery: a randomized controlled trial. World J Surg. 2012 Sep;36(9):2039-44. doi: 10.1007/s00268-012-1649-2.
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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.
Hany A Mowafi, MD principal investigator
UD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol and Lornoxicam in people with Postoperative Pain, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
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 1 inclusion and 3 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 28 Mar 2012. 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Postoperative pain (time frame: 24 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 NCT01564680, 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 28 Mar 2012.