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Lornoxicam vs. Paracetamol After Lower Abdominal Surgery

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Phase 4

Locations

Saudi Arabia

Study Type

Interventional

Intervention

placebo

Paracetamol

Lornoxicam

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Lower abdominal surgery, Paracetamol, Lornoxicam, Morphine

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

lower abdominal surgery

Exclusion Criteria:

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

Sites / Locations

Dammam University, KFHU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Lornoxicam

Control

Paracetamol

Arm Description

Lornoxicam 16 mg will be given at skin closure and 8 mg will be given 12 hours postoperatively

Patients will receive normal saline at skin closure, at 6, 12, 18 hours postoperatively.

1 gm of paracetamol will be given at skin closure, 6, 12, 18 hours postoperatively

Outcomes

Primary Outcome Measures

Postoperative pain

Postoperative pain scores measured by the verbal pain score (VPS)1, 2, 4, 8, 12 and 24 hours postoperatively.

Secondary Outcome Measures

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

Incidence of side-effects

incidence of side effects was measured at 1,2,4,8, 12, 24 hr postoperatively.

Full Information

NCT ID

NCT01564680

First Posted

March 26, 2012

Last Updated

March 27, 2012

Sponsor

Imam Abdulrahman Bin Faisal University

1. Study Identification

Unique Protocol Identification Number

NCT01564680

Brief Title

Lornoxicam vs. Paracetamol After Lower Abdominal Surgery

Official Title

Intravenous Lornoxicam is More Effective Than Paracetamol as a Supplemental Analgesic After Lower Abdominal Surgery; A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Imam Abdulrahman Bin Faisal University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

Lower abdominal surgery, Paracetamol, Lornoxicam, Morphine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lornoxicam

Arm Type

Experimental

Arm Description

Lornoxicam 16 mg will be given at skin closure and 8 mg will be given 12 hours postoperatively

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Patients will receive normal saline at skin closure, at 6, 12, 18 hours postoperatively.

Arm Title

Paracetamol

Arm Type

Experimental

Arm Description

1 gm of paracetamol will be given at skin closure, 6, 12, 18 hours postoperatively

Intervention Type

Other

Intervention Name(s)

placebo

Other Intervention Name(s)

0.9 N sodium chloride

Intervention Description

normal saline

Intervention Type

Drug

Intervention Name(s)

Paracetamol

Other Intervention Name(s)

perfalgan

Intervention Description

IV paracetamol infusion

Intervention Type

Drug

Intervention Name(s)

Lornoxicam

Other Intervention Name(s)

xefo

Intervention Description

16 mg at skin closure and 8 mg 12 hours postoperative

Primary Outcome Measure Information:

Title

Postoperative pain

Description

Postoperative pain scores measured by the verbal pain score (VPS)1, 2, 4, 8, 12 and 24 hours postoperatively.

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Morphine consumption

Description

pain was treated postoperatively using morphine patient-controlled analgesia. Morphine consumption was measured at 1, 2, 4, 8, 12 and 24 hours postoperatively

Time Frame

24 hours

Title

Incidence of side-effects

Description

incidence of side effects was measured at 1,2,4,8, 12, 24 hr postoperatively.

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: lower abdominal surgery Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hany A Mowafi, MD

Organizational Affiliation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dammam University, KFHU

City

Al-Khobar

State/Province

ZIP/Postal Code

31952

Country

Saudi Arabia

12. IPD Sharing Statement

Citations:

PubMed Identifier

22584689

Citation

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.

Results Reference

derived

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Lornoxicam vs. Paracetamol After Lower Abdominal Surgery

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