NCT01564680

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 postoperative-pain

Timeline
Completed

Started Mar 2009

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
Last Updated

March 28, 2012

Status Verified

March 1, 2012

Enrollment Period

2 years

First QC Date

March 26, 2012

Last Update Submit

March 27, 2012

Conditions

Postoperative Pain

Keywords

Lower abdominal surgeryParacetamolLornoxicamMorphine

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

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

    24 hours

Secondary Outcomes (2)

  • Morphine consumption

    24 hours

  • Incidence of side-effects

    24 hours

Study Arms (3)

Lornoxicam

EXPERIMENTAL

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

Drug: Lornoxicam

Control

PLACEBO COMPARATOR

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

Other: placebo

Paracetamol

EXPERIMENTAL

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

Drug: Paracetamol

Interventions

placeboOTHER

normal saline

Also known as: 0.9 N sodium chloride
Control
ParacetamolDRUG

IV paracetamol infusion

Also known as: perfalgan
Paracetamol
LornoxicamDRUG

16 mg at skin closure and 8 mg 12 hours postoperative

Also known as: xefo
Lornoxicam

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lower abdominal surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dammam University, KFHU

Khobar, EP, 31952, Saudi Arabia

Location

Related Publications (1)

  • 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.

    PMID: 22584689DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophenlornoxicam

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Hany A Mowafi, MD

    UD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2012

First Posted

March 28, 2012

Study Start

March 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 28, 2012

Record last verified: 2012-03

Locations

SA(1)