Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics

Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics in Patients Undergoing Laparoscopic or Open Inguinal and/or Umbilical Hernia Repair? A Randomized, Double-Blind, Prospective Trial

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01297829

Enrollment

Registered

2011-02-17

Start date

2011-02-28

Completion date

2015-03-31

Last updated

2014-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

ibuprofen, postoperative narcotics, visual analog pain scale, inguinal hernia repair, umbilical hernia repair

Brief summary

Caldolor® is an intravenous (IV) formulation of ibuprofen encompassing analgesic, anti-inflammatory and antipyretic (anti-fever) properties. Caldolor® is the first IV antipyretic approved by the US Food and Drug Administration (FDA), providing an alternate route for administration of ibuprofen when the oral route is not preferable. Recent studies have reported that Caldolor® decreases morphine use and pain at rest and with movement compared to patients not receiving this drug. The hypothesis of the proposed study is that a single dose of Caldolor® 800 mg given 30 minutes preoperatively for patients undergoing laparoscopic or open inguinal and/or umbilical hernia repair will result in a \>20% decrease in postoperative narcotic use within the first 24 hours and at 7 days, and decreased VAS Pain Score at 2 hours, 1 day, 3 days and 7 days after surgery. The use of less postoperative narcotics has been associated with a faster return of normal bowel function and resumption of normal ambulatory status thus resulting in improved general well being for the patient.

Interventions

DRUGIntravenous Ibuprofen

800 mg IV ibuprofen 30 minutes preoperatively

OTHERIV Placebo

IV normal saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* primary inguinal and/or umbilical hernia repair * age \> 18 years old

Exclusion criteria

* history of gastrointestinal bleeding * allergy to ibuprofen * creatinine \> 1.5 mg/dL

Design outcomes

Primary

Measure	Time frame	Description
Postoperative Narcotic Use	7 days	Post-operatively, the patient will receive a journal to record daily medication used up to and including post-operative day 7.

Secondary

Measure	Time frame	Description
Postoperative Visual Analog Pain Scale	7 days	The patient will receive a Visual Analog Pain Scale to complete 2 hrs post-operatively, post-operative day 1, post-operative day 3 and post-operative day 7

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026