Inguinal HerniaPhase 3NCT01069055
Comparison of Lornoxicam and Paracetamol for Pre-emptive Intravenous Analgesia for Elective Inguinal Hernia Repair
A Phase 3 study testing Sterile Saline, Intravenous lornoxicam and Intravenous paracetamol in people with Inguinal Hernia and Postoperative Pain, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine whether lornoxicam or paracetamol is more effective in providing pre-emptive analgesia for adult patients undergoing elective unilateral inguinal hernia repair under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia, Postoperative Pain
- What is being tested?
- Sterile Saline, Intravenous lornoxicam and Intravenous paracetamol
- 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 siteTurkey (Türkiye)
- Study dates
- Feb 2010to Jun 2010
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- inguinal hernia
- unilateral hernia
- general anesthesia
- elective repair
Who cannot join
- drug allergy
- bilateral hernia
- local anesthesia
- local blockade
- regional anesthesia
- emergency surgery
- complicated hernia
- recurrent hernia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Teaching and Research Hospital
Ankara
Alp Alptekin, MD, +90 312 5962370, alptekinmd@yahoo.com
Hakan Kulacoglu, MD, FACS, hakankulacoglu@hotmail.com
About this study
Official title: Pre-emptive Intravenous Analgesia for Elective Inguinal Hernia Repair: Prospective Randomized Double-blinded Placebo Controlled Comparison of Lornoxicam and Paracetamol
The purpose of this study is to determine whether lornoxicam or paracetamol is more effective in providing pre-emptive analgesia for adult patients undergoing elective unilateral inguinal hernia repair under general anesthesia.
Read the detailed description
Early postoperative pain is the major cause that may restric physical activity of the patients and delay in returning work. Newer non-steroid analgesic drugs (NSAD) can be helpful in overcoming this problem, especially in pre-emptive use. In this prospective randomized placebo controlled double blinded study we aimed to determine whether lornoxicam, as a NSAD, or paracetamol is more effective in providing pre-emptive analgesia for patients undergo elective unilateral inguinal hernai repair under general anesthesia. 60 patients above the age of 18, ASA score of I to III will be assigned into 3 groups. All the patients will be operated under general anesthesia. Recurrent hernia cases, pregnant or lactated women, patients allergic to the two drugs, patients with documented gastric disorders or bleeding disorder or under anticoagulent therapy will be excluded.
Group designs:
Group I: 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.
Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.
Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.
All patients will receive patient controlled intravenous analgesia with morphine for 24 hours postoperatively.
Postoperative pain levels will be determined by VAS (visual analog scale) and morphine consumption will be recorded.
Patients will be prescribed with oral paracetamol (300 mg) plus codein (15 mg)at discharge at the end first 24 hours.
Patients will be asked to record daily consumption of given analgesic, pain response to physical activity by using Likert scale, and VAS scores daily.
The first follow-up examination will take place on day-7. The patients will be asked to keep recording the same parameters until the second hospital visit at 4th week.
On the follow-up examination at 4th week quality of life will be determined by SF-36 form.
The results will be analyzed using SPSS for Windows software.
- Conditions
- Inguinal Hernia, Postoperative Pain
- Being tested
- Sterile Saline, Intravenous lornoxicam, Intravenous paracetamol
- Keywords
- inguinal hernia, surgery, general anesthesia, analgesia, pre-emptive, SF36
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile SalineOther
Also called Saline
Group I: 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.
Intravenous lornoxicamDrug
Also called Lornoxicam: Xefo
Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.
Intravenous paracetamolDrug
Also called Paracetamol: Perfalgan
Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control | Placebo comparator | Group I (Placebo Control) 100 ml intravenous saline infusion as placebo 30 minitues before the surgery. Receives: Other: Sterile Saline |
| Lornoxicam | Active comparator | Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery. Receives: Drug: Intravenous lornoxicam |
| Paracetamol | Active comparator | Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery. Receives: Drug: Intravenous paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain and comfort
Measured: 24 and 48 hours
Secondary outcomes (1)
Postoperative late pain complaint and quality of life
Measured: 4. week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ercan Sonmez, MD, Principal investigator, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069055
- Sponsor's protocol ID
- HerniaAnalgesia2010-001
- Status last verified
- Feb 2010
- First submitted
- 16 Feb 2010
- Last updated
- 24 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-emptive Intravenous Analgesia for Elective Inguinal Hernia Repair: Prospective Randomized Double-blinded Placebo Controlled Comparison of Lornoxicam and Paracetamol
- ClinicalTrials.gov ID
- NCT01069055
- Acronym / sponsor ID
- HerniaAnalgesia2010-001
- Conditions
- Inguinal Hernia, Postoperative Pain
- Keywords
- inguinal hernia, surgery, general anesthesia, analgesia, pre-emptive, SF36
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 17 Feb 2010 (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.
The purpose of this study is to determine whether lornoxicam or paracetamol is more effective in providing pre-emptive analgesia for adult patients undergoing elective unilateral inguinal hernia repair under general anesthesia.
Detailed description
Early postoperative pain is the major cause that may restric physical activity of the patients and delay in returning work. Newer non-steroid analgesic drugs (NSAD) can be helpful in overcoming this problem, especially in pre-emptive use. In this prospective randomized placebo controlled double blinded study we aimed to determine whether lornoxicam, as a NSAD, or paracetamol is more effective in providing pre-emptive analgesia for patients undergo elective unilateral inguinal hernai repair under general anesthesia. 60 patients above the age of 18, ASA score of I to III will be assigned into 3 groups. All the patients will be operated under general anesthesia. Recurrent hernia cases, pregnant or lactated women, patients allergic to the two drugs, patients with documented gastric disorders or bleeding disorder or under anticoagulent therapy will be excluded.
Group designs:
Group I: 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.
Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.
Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.
All patients will receive patient controlled intravenous analgesia with morphine for 24 hours postoperatively.
Postoperative pain levels will be determined by VAS (visual analog scale) and morphine consumption will be recorded.
Patients will be prescribed with oral paracetamol (300 mg) plus codein (15 mg)at discharge at the end first 24 hours.
Patients will be asked to record daily consumption of given analgesic, pain response to physical activity by using Likert scale, and VAS scores daily.
The first follow-up examination will take place on day-7. The patients will be asked to keep recording the same parameters until the second hospital visit at 4th week.
On the follow-up examination at 4th week quality of life will be determined by SF-36 form.
The results will be analyzed using SPSS for Windows software.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Control | Placebo comparator | Other: Sterile SalineGroup I (Placebo Control) 100 ml intravenous saline infusion as placebo 30 minitues before the surgery. |
| Lornoxicam | Active comparator | Drug: Intravenous lornoxicamGroup II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery. |
| Paracetamol | Active comparator | Drug: Intravenous paracetamolGroup III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- inguinal hernia
- unilateral hernia
- general anesthesia
- elective repair
Key exclusion criteria (8 listed)
- drug allergy
- bilateral hernia
- local anesthesia
- local blockade
- regional anesthesia
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 |
|---|---|---|
| Sterile SalineAlso: SalineGroup I: 100 ml intravenous saline infusion as placebo 30 minitues before the surgery. | Other | Placebo Control |
| Intravenous lornoxicamAlso: Lornoxicam: XefoGroup II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery. | Drug | Lornoxicam |
| Intravenous paracetamolAlso: Paracetamol: PerfalganGroup III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery. | Drug | Paracetamol |
Primary outcome
Postoperative pain and comfort
Time frame: 24 and 48 hours
1 secondary outcome
Postoperative late pain complaint and quality of life
Time frame: 4. week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2010.
Related trials for Inguinal Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
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.
Ercan Sonmez, MD principal investigator
Diskapi Teaching and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sterile Saline, Intravenous lornoxicam and Intravenous paracetamol in people with Inguinal Hernia and Postoperative Pain, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 24 Feb 2010. 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 Turkey (Türkiye). 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain and comfort (time frame: 24 and 48 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 24 Feb 2010.