Comparison of Lornoxicam and Paracetamol for Pre-emptive Intravenous Analgesia for Elective Inguinal Hernia Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Diskapi Teaching and Research Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT01069055
First received: February 16, 2010
Last updated: February 23, 2010
Last verified: February 2010
  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

Resource links provided by NLM:


Further study details as provided by Diskapi Teaching and Research Hospital:

Primary Outcome Measures:
  • Postoperative pain and comfort [ Time Frame: 24 and 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069055

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   
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
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, Inguinal
Hernia
Pain, Postoperative
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Hernia, Abdominal
Lornoxicam
Piroxicam
Acetaminophen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipyretics

ClinicalTrials.gov processed this record on September 30, 2014