Comparison of Lornoxicam and Paracetamol for Pre-emptive Intravenous Analgesia for Elective Inguinal Hernia Repair
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Inguinal Hernia Postoperative Pain |
Other: Sterile Saline Drug: Intravenous lornoxicam Drug: Intravenous paracetamol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Pre-emptive Intravenous Analgesia for Elective Inguinal Hernia Repair: Prospective Randomized Double-blinded Placebo Controlled Comparison of Lornoxicam and Paracetamol |
- Postoperative pain and comfort [ Time Frame: 24 and 48 hours ] [ Designated as safety issue: Yes ]
- Postoperative late pain complaint and quality of life [ Time Frame: 4. week ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo Control
Group I (Placebo Control) 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.
|
Other: Sterile Saline
Group I: 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.
Other Name: Saline
|
|
Active Comparator: Lornoxicam
Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.
|
Drug: Intravenous lornoxicam
Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.
Other Name: Lornoxicam: Xefo
|
|
Active Comparator: Paracetamol
Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.
|
Drug: Intravenous paracetamol
Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.
Other Name: Paracetamol: Perfalgan
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- inguinal hernia
- unilateral hernia
- general anesthesia
- elective repair
Exclusion Criteria:
- drug allergy
- bilateral hernia
- local anesthesia
- local blockade
- regional anesthesia
- emergency surgery
- complicated hernia
- recurrent hernia
Contacts and Locations| Turkey | |
| Diskapi Teaching and Research Hospital | Not yet recruiting |
| Ankara, Turkey | |
| Contact: Alp Alptekin, MD +90 312 5962370 alptekinmd@yahoo.com | |
| Contact: Hakan Kulacoglu, MD, FACS hakankulacoglu@hotmail.com | |
| Principal Investigator: | Ercan Sonmez, MD | Diskapi Teaching and Research Hospital |
More Information
No publications provided
| Responsible Party: | Diskapi Teaching and Research Hospital, Ministry of Health |
| ClinicalTrials.gov Identifier: | NCT01069055 History of Changes |
| Other Study ID Numbers: | HerniaAnalgesia2010-001 |
| Study First Received: | February 16, 2010 |
| Last Updated: | February 23, 2010 |
| Health Authority: | Turkey: Ministry of Health |
Keywords provided by Diskapi Teaching and Research Hospital:
|
inguinal hernia surgery general anesthesia |
analgesia pre-emptive SF36 |
Additional relevant MeSH terms:
|
Hernia Hernia, Inguinal Pain, Postoperative Pathological Conditions, Anatomical Hernia, Abdominal Postoperative Complications Pathologic Processes Pain Signs and Symptoms Acetaminophen Lornoxicam Piroxicam Antipyretics Physiological Effects of Drugs |
Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013